Virus DiseasesPhase 2NCT02469298

Safety, Tolerability and Clinical Effect of Danirixin in Adults With Influenza

A Phase 2 study testing GSK1325756 (Danirixin) and Oseltamivir Phosphate in people with Virus Diseases, run by GlaxoSmithKline at 33 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Virus Diseases
What is being tested?: GSK1325756 (Danirixin) and Oseltamivir Phosphate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 45 participants
Where: 33 sitesin 3 countries
Study dates: 1 Jun 2015to 25 Apr 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Between 18 and 64 years of age inclusive, at the time of signing the informed consent;
Onset of influenza-like illness symptoms within 48 hours prior to study enrollment. Onset of symptoms is defined as the time when the subject's temperature was measured as elevated (>=38.0°C [>=100.4°F]) OR the time when the subject first experienced at least one symptom (cough, sore throat, nasal congestion, headache, feeling feverish, body aches and pains, or fatigue);
Subjects have an oral temperature >=38.0°C (>=100.4°F) at screening visit or history of feeling feverish within the 24 hours prior to screening visit;
At least one respiratory symptom (cough, sore throat, nasal congestion) and at least one systemic symptom (headache, body aches and pain, fatigue) due to influenza infection;
A positive influenza rapid antigen test;
Body weight >60 Kilogram (kg) for men and >45 kg for women; and Body Mass Index (BMI) between 19 to 35 kilogram per meters squared (kg/m^2), inclusive;

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Male or Female subjects could be eligible if :
Male subjects with female partners of child-bearing potential must comply with the following contraception requirements from the time of first dose of study medication until at least 36 hours (five half-lives) of study medication after the last dose of study medication:
Vasectomy with documentation of azoospermia; Male condom plus partner use of one of the following contraceptive options: Contraceptive subdermal implant; Intrauterine device or intrauterine system; Oral Contraceptive, either combined or progestogen alone; Injectable progestogen; Contraceptive vaginal ring ; Percutaneous contraceptive patches; This is an all-inclusive list of those methods that meet the following GlaxoSmithKline (GSK) definition of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. For non-product methods (e.g., male sterility), the investigator determines what is consistent and correct use. The GSK definition is based on the definition provided by the International Conference on Harmonisation (ICH). The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception;
Female subject: is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin [hCG] test), not lactating, and at least one of the following conditions applies
Non-reproductive potential defined as:
Pre-menopausal females with one of the following: documented Tubal ligation; Documented Hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; Hysterectomy; Documented Bilateral oophorectomy; Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone [FSH] and estradiol levels consistent with menopause). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study.
Reproductive potential agrees to follow one of the options listed below in the GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from the time of screening, during dosing, and until at least 36 hrs after the last dose of study medication and completion of the follow-up visit.
GSK List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) meeting GSK criteria of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. This list does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penilevaginal intercourse on a long term and persistent basis.
Contraceptive subdermal implant; Intrauterine device or intrauterine system; Combined estrogen and progestogen oral contraceptive; Injectable progestogen; Contraceptive vaginal ring; Percutaneous contraceptive patches; Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject.
These allowed methods of contraception are only effective when used consistently, correctly and in accordance with the product label. The investigator is responsible for ensuring that subjects understand how to properly use these methods of contraception.
Subjects willing and able to give written informed consent to participate in the study and to adhere to the procedures stated in the protocol.

Who cannot join

Subject defined as being at high risk of complications from influenza infection according to the World Health Organization (WHO) Guidelines for Pharmacological Management of Pandemic Influenza A (H1N1) and other Influenza Viruses: Pregnant women; Persons of any age with chronic pulmonary disease (e.g. Mild persistent, Moderate or severe asthma, Chronic Obstruction Pulmonary Disease [COPD], cystic fibrosis, bronchiectasis); Persons of any age with chronic cardiac disease (e.g. congestive cardiac failure);
Persons with metabolic disorders (e.g. diabetes); Persons with chronic renal disease, chronic hepatic disease, certain neurological conditions (including neuromuscular, neurocognitive and seizure disorders, but not including autism spectrum disorders); Hemoglobinopathies, or immunosuppression, whether due to primary immunosuppressive conditions, such as Human Immunodeficiency Virus (HIV) infection, or secondary conditions, such as immunosuppressive medication or malignancy;
Subjects in whom treatment with an influenza antiviral is considered essential;
Severity of illness requiring or anticipated to require in-hospital care;
Pulse Oximetry levels <92% (at rest on room air) at screening or requirement for supplemental oxygen;
Any complication of respiratory tract infection, signs of severe or progressive disease, or worsening of any pre-existing medical condition at the time of enrollment, that, in the opinion of the investigator, would place the subject at an unreasonably increased risk of participation in this study;

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Suspicion or confirmation of bacterial infection (e.g. otitis media, sinusitis, bronchitis, focal pneumonia) or who are requiring oral or systemic antibiotics within one week before enrollment;
Women who are pregnant as determined by a positive urine human chorionic gonadotrophin (hCG) test prior to dosing or women who are breastfeeding;
Current or chronic documented history of liver disease (including Hepatitis A, B, or C), or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones); In this case "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records). In questionable cases the subject cannot be enrolled;
Corrected QT interval (QTc) >450 millisecond (msec) or QTc >480 msec in subjects with Bundle Branch Block.
Subjects currently using or expected to use: oral or injectable Cytochrome P450 3A4 (CYP3A4) or Breast Cancer Resistance Protein (BCRP) substrates with a narrow therapeutic index, or oral or systemic glucocorticoids during the study period; Antacids can be used but should not be taken for at least 3 hours preceding and 2 hours after administration of study drug; proton pump inhibitors and histamine H2-receptor antagonists are prohibited from the screening visit until 12 hours after completion of the final dose of study treatment.
Subjects who have taken an approved or investigational anti-influenza medication (e.g., oseltamivir, zanamivir, peramivir, laninamivir, amantadine, rimantidine, ribavirin) within the past 4 weeks before enrollment;
Subjects who received the live attenuated influenza virus vaccine within the past 21 days;
Subjects treated with systemic steroids or immunosuppressants within 2 weeks of study start.
History of alcohol/drug abuse within 6 months of the study start;
Consumption of >3 alcoholic units for males and females over the past 24 hours. One unit is equivalent to 8 grams of alcohol: a half-pint (~240 milliliter [mL]) of beer; 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period;
The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer);
Exposure to more than four investigational medicinal products within 12 months prior to the first dosing day.

Trial locations and contacts

33 sites in 3 countries.

Country

City, postcode or hospital

33 sites in 3 countries

Australia20 sites

GSK Investigational Site
Applecross, Western Australia, 6153
GSK Investigational Site
Baldivis, Western Australia, 6171
GSK Investigational Site
Baulkham Hills, New South Wales, 2153
GSK Investigational Site
Berwick, Victoria, 3806
GSK Investigational Site
Brookvale, New South Wales, 2100
GSK Investigational Site
Browns Plains, Queensland, 4118
GSK Investigational Site
Claremont, Western Australia, 6010
GSK Investigational Site
Everton Plaza, Queensland, 4053
GSK Investigational Site
Glenelg East, South Australia, 5045
GSK Investigational Site
Happy Valley, South Australia, 5159
GSK Investigational Site
Hinchinbrook, New South Wales, 2168
GSK Investigational Site
Kedron, Queensland, 4031
GSK Investigational Site
Liverpool, New South Wales, 2170
GSK Investigational Site
Lynbrook, Victoria, 3975
GSK Investigational Site
Morley, Western Australia, 6062
GSK Investigational Site
Noble Park, Victoria, 3174
GSK Investigational Site
Pakenham, Victoria, 3180
GSK Investigational Site
Springfield, Queensland, 4300
GSK Investigational Site
Tarneit, Victoria, 3029
GSK Investigational Site
Yokine, Western Australia, 6060

Other trials in Australia

South Africa8 sites

GSK Investigational Site
Johannesburg, Gauteng, 1818
GSK Investigational Site
Johannesburg, Gauteng, 2113
GSK Investigational Site
Middelburg, Mpumalanga, 1055
GSK Investigational Site
Moloto South, Gauteng, 1022
GSK Investigational Site
Port Elizabeth, Eastern Cape, 6001
GSK Investigational Site
Pretoria, Gauteng, 0152
GSK Investigational Site
Reiger Park, 1459
GSK Investigational Site
Western Cape, Western Province

Other trials in South Africa

United States5 sites

GSK Investigational Site
Blackfoot, Idaho, 83221
GSK Investigational Site
Marshfield, Wisconsin, 54449
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Oklahoma City, Oklahoma, 73120
GSK Investigational Site
Palmetto Bay, Florida, 33157

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety, Tolerability and Clinical Effect of Oral Danirixin (GSK1325756) in the Treatment of Healthy Adults With Acute, Uncomplicated Influenza (201682)

Study 201682 is a Phase IIa, randomized, double blind, placebo-controlled four arm outpatient study evaluating the safety, tolerability and clinical effect of danirixin or danirixin + oseltamivir combination in comparison to placebo or oseltamivir twice daily for 5 days in otherwise healthy adults with laboratory confirmed influenza infection. Danirixin is a selective and reversible C-X-C Chemokine Receptor 2 (CXCR2) antagonist that inhibits neutrophil transmigration and activation to areas of inflammation. The study endpoints are intended to test the hypothesis that inhibition of neutrophil activation by approximately 50-60% (as previously measured by cluster of differentiation [CD11b] expression in response to chemokine [C-X-C motif] ligand 1 [CXCL1] stimulation ex vivo in human studies) will not impact safety parameters or worsen clinical manifestations of disease, disease-related events of interest, or viral load, and may possibly improve these parameters when administered within 48 hours of symptom onset. The aim of this exploratory study is to obtain data on the safety, tolerability and clinical effect of GSK1325756 (danirixin [DNX]) alone or in combination with oseltamivir (OSV) in otherwise healthy adults with acute, uncomplicated influenza prior to future evaluation in hospitalized patients with complicated influenza. The primary objective is to assess safety and tolerability of DNX with and without a neuraminidase inhibitor through the evaluation of AEs, SAEs, clinical laboratory tests, vital signs, and electrocardiogram (ECG) parameters. Safety assessments will also include an assessment of disease related events (DREs) of interest and associated antibiotic use. The Influenza Intensity and Impact Questionnaire (FluiiQ™) will be used in the study to document patient reported outcomes (PROs). The screening visit in Australia will be composed of a pre-screen for influenza infection with an influenza rapid antigen test followed by a screen for the remaining eligibility criteria for those subjects with a positive result on the influenza rapid antigen test. FluiiQ is trademark owned by Measured Solutions for Health Private Limited.

Conditions: Virus Diseases
Being tested: GSK1325756 (Danirixin), Placebo To Match GSK1325756, Oseltamivir Phosphate, Placebo To Match Oseltamivir Phosphate
Keywords: acute, uncomplicated influenza, Danirixin, oseltamivir
Medical subject headings: Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK1325756 (Danirixin)Drug
It will be supplied as capsule shaped white film coated tablet containing 75 mg GSK1325756 for oral use
Placebo To Match GSK1325756Drug
It will be supplied as capsule shaped white film coated placebo tablet for oral use
Oseltamivir PhosphateDrug
It will be supplied as size 0 Swedish Orange capsule containing 75 mg Oseltamivir phosphate and overfill of pre-gelatinized starch for oral use
Placebo To Match Oseltamivir PhosphateDrug
It will be supplied as size 0 Swedish Orange capsule containing pre-gelatinized starch and magnesium stearate for oral use

Study groups in NCT02469298
Study group	Role	What they receive
Danirixin + Oseltamivir matching placebo	Experimental	Subjects will receive 75 mg oral Danirixin twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days Receives: Drug: GSK1325756 (Danirixin); Drug: Placebo To Match Oseltamivir Phosphate
Danirixin matching placebo + Oseltamivir matching placebo	Placebo comparator	Subjects will receive Danirixin matching placebo twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days Receives: Drug: Placebo To Match GSK1325756; Drug: Placebo To Match Oseltamivir Phosphate
Danirixin + Oseltamivir	Experimental	Subjects will receive 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days Receives: Drug: GSK1325756 (Danirixin); Drug: Oseltamivir Phosphate
Danirixin matching placebo + Oseltamivir	Active comparator	Subjects will receive Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days Receives: Drug: Placebo To Match GSK1325756; Drug: Oseltamivir Phosphate

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
Measured: Up to Day 28/withdrawal
Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count
Hematology parameters included Basophils, Eosinophils, Lymphocytes, Monocytes, Total neutrophils (Total ANC), Platelet count and WBC count. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Measured: Baseline (Day 1) and up to Day 28/withdrawal
Change From Baseline in Hematology Parameters- Hemoglobin
Hematology parameters included Hemoglobin. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Measured: Baseline (Day 1) and up to Day 28/withdrawal
Change From Baseline in Hematology Parameters- Hematocrit
Hematology parameters included Hematocrit. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Measured: Baseline (Day 1) and up to Day 28/withdrawal
Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH)
Hematology parameters included Mean corpuscle hemoglobin (MCH). Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Measured: Baseline (Day 1) and up to Day 28/withdrawal
Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV)
Hematology parameters included Mean corpuscle volume (MCV). Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Measured: Baseline (Day 1) and up to Day 28/withdrawal
Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count
Hematology parameters included RBC count and Reticulocytes count. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Measured: Baseline (Day 1) and up to Day 28/withdrawal
Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein
Clinical chemistry parameters included Albumin and Total protein. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Measured: Baseline (Day 1) and up to Day 28/withdrawal
Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT)
Clinical chemistry parameters included Alkaline phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase and Gamma Glutamyl Transferase. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Measured: Baseline (Day 1) and up to Day 28/withdrawal
Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid
Clinical chemistry parameters included Direct Bilirubin, Total Bilirubin, Creatinine and Uric acid. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Measured: Baseline (Day 1) and up to Day 28/withdrawal
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)
Clinical chemistry parameters included Calcium, CO2 content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/(BUN). Blood samples were collected on Day 1, Day 3, Day 5 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Measured: Baseline (Day 1) and up to Day 28/withdrawal
Change From Baseline in Urinalysis Parameters- Urine pH
Urinalysis parameters included urine pH. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. Urinalysis was done on Day 1, Day 5 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Measured: Baseline (Day 1), Day 5 and Day 28/withdrawal
Change From Baseline in Urinalysis Parameters- Urine Specific Gravity
Urinalysis parameter included Urine specific gravity and was measured on Day 1, Day 5 and Day 28. Urinary specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Measured: Baseline (Day 1), Day 5 and Day 28/withdrawal
Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick)
The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine occult blood can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.
Measured: Up to Day 28/withdrawal
Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick)
The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine glucose can be read as negative, Trace, 1+ or 1/4 gram per deciliter (G/dL), 2+ OR 1/2 G/dL, 3+ or 1 G/dL and 4+ indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.
Measured: Up to Day 28/withdrawal
Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick)
The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.
Measured: Up to Day 28/withdrawal
Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Vital signs were measured in semi-supine position after 5 minutes rest and included systolic and diastolic blood pressure. Three readings of blood pressure were taken; the first reading was rejected and the second and third readings were averaged to give the measurement to be recorded. Vital signs were obtained on Baseline (Day 1), Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Measured: Baseline (Day 1) and up to Day 28/withdrawal
Change From Baseline in Vital Signs- Heart Rate (HR)
Vital signs were measured in semi-supine position after 5 minutes rest and included HR. Three readings of pulse rate were taken; the first reading was rejected and the second and third readings were averaged to give the measurement to be recorded. Vital signs were obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Measured: Baseline (Day 1) and up to Day 28/withdrawal
Change From Baseline in Vital Signs- Respiration Rate (RR)
Vital signs were measured in semi-supine position after 5 minutes rest and included RR. RR was obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Measured: Baseline (Day 1) and up to Day 28/withdrawal
Change From Baseline in Vital Signs- Temperature
Vital signs were measured in semi-supine position after 5 minutes rest and included temperature. Oral temperature was obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Measured: Baseline (Day 1) and up to Day 28/withdrawal
Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB)
Vital signs were measured in semi-supine position after 5 minutes rest and included POB. POB was obtained on Baseline (Day 1), Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Measured: Baseline (Day 1) and up to Day 28/withdrawal
Change From Baseline in Electrocardiogram (ECG) Parameters
12-lead ECGs were obtained on Day 1, Day 3 and Day28/withdrawal using an ECG machine that automatically calculates and measures RR, PR, QRS, QT, and Corrected QT Interval using Bazette's formula (QTcB) and Corrected QT Interval using Fridericia forumula (QTcF) intervals. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Measured: Baseline (Day 1) and up to Day 28/withdrawal
Number of Participants With Disease Related Events (DREs) of Interest
Disease-related events of interest included Otitis media, Sinusitis, Bronchitis and Pneumonia and were captured separately from AEs and SAEs. DREs of interest were assessed and recorded by the site on all clinical visit days.
Measured: Up to Day 28/withdrawal
Number of Participants With DRE of Interest-associated Antibiotic Use
Use of antibiotics for DREs of interest was monitored. Roxithromycin was used for DRE sinusitis by one participant.
Measured: Up to Day 28/withdrawal

Secondary outcomes (9)

Time to Resolution of Fever Over Time Post Initiation of Treatment
Time to resolution of fever was defined as the time when oral temperature was <= 37.2 degree Celsius (<=99.0 degree Fahrenheit) for at least 24 hours (with one hour window) without having taken any antipyretic medication for at least 4 hours. Temperature was taken orally and recorded in the eDiary, thrice daily from Day 1 to Day 5 (morning, noon, evening) and twice daily (morning, evening) from Day 6 to Day 14 by the participant using a digital thermometer provided by the study. For participants whose fever was not resolved by the Day 14 visit then after Day 14, participants continued to take oral temperature twice daily until temperature <=37.2 degree Celsius or <=99 degree Fahrenheit for 24 hours.
Measured: Up to Day 28/withdrawal
Number of Afebrile Participants Over Time Post Initiation of Treatment
Afebrile participants were defined as participants with oral temperature <=37.2 degree Celsius, <=99.0 degree Fahrenheit over time post initiation of treatment. Temperature was taken orally and recorded in the eDiary, thrice daily from Day 1 to Day 5 (morning, noon, evening) and twice daily (morning, evening) from Day 6 to Day 14 by the participant using a digital thermometer provided by the study. For participants whose fever was not resolved by the Day 14 visit then after Day 14, participants continued to take oral temperature twice daily until temperature <=37.2 degree Celsius or <=99 degree Fahrenheit for 24 hours.
Measured: Up to Day 28/withdrawal
Number of Participants Who Used Relief Medication
Use of study supplied relief medications (paracetamol and dextromethorphan for symptom relief were recorded in the eDiary and accordingly number of participants using these medications were recorded.
Measured: Up to Day 28/withdrawal
Number of Hospital Admissions Due to Influenza Infection
Number of participants admitted in hospital due to influenza infection was recorded.
Measured: Up to Day 28/withdrawal
Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14
Influenza viral load as measured by quantitative reverse transcription - polymerase chain reaction (qRT-PCR) from nasopharyngeal swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 was recorded. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Measured: Baseline (Day 1) and Day 3, Day 5, Day 8 and Day 14
Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14
Number of participants with no detectable influenza viral ribonucleic acid (RNA) by qRT-PCR from nasopharyngeal swabs on Baseline (Day1), Day 3, Day 5, Day 8 and Day 14 were recorded. Assessments recorded on Day 1 were considered as Baseline.
Measured: Up to Day 14
Total Dose of Relief Medication
Use of study supplied relief medications (paracetamol and dextromethorphan for symptom relief were recorded in the eDiary and accordingly number of participants using these medications were recorded. The total dose of these relief medications used by these participants are presented.
Measured: Up to Day 28/withdrawal
Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14
Influenza viral load as measured by quantitative virus culture from nasopharyngeal swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14 was recorded. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Measured: Baseline (Day 1) and Day 3, Day 5, Day 8 and Day 14
Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14
Number of participants with no detectable influenza viral RNA by quantitative virus culture from nasopharyngeal swabs on Baseline (Day1), Day 3, Day 5, Day 8 and Day 14 were recorded. Assessments recorded on Day 1 were considered as Baseline.
Measured: Up to Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201525 Apr 2016

First posted11 Jun 2015 (estimated)
Study start1 Jun 2015
Primary completion25 Apr 2016
Study completion25 Apr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Virus DiseasesStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02469298
Sponsor's protocol ID: 201682
Status last verified: Jul 2019
First submitted: 23 Apr 2015
Last updated: 23 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

Publications

Roberts G, Chen S, Yates P, Madan A, Walker J, Washburn ML, Peat AJ, Soucie G, Kerwin E, Roy-Ghanta S. Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Clinical Effect of Danirixin in Adults With Acute, Uncomplicated Influenza. Open Forum Infect Dis. 2019 Apr 22;6(4):ofz072. doi: 10.1093/ofid/ofz072. eCollection 2019 Apr.
PubMed 31024969

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The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

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What is the study trying to find out?
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Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
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Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Virus Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety, Tolerability and Clinical Effect of Oral Danirixin (GSK1325756) in the Treatment of Healthy Adults With Acute, Uncomplicated Influenza (201682)
ClinicalTrials.gov ID: NCT02469298
Acronym / sponsor ID: 201682
Conditions: Virus Diseases
Keywords: acute, uncomplicated influenza, Danirixin, oseltamivir
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Jun 2015 (actual)
Primary completion: 25 Apr 2016 (actual)
Study completion: 25 Apr 2016 (actual)
First posted: 11 Jun 2015 (estimated)
Results: Posted 24 Aug 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Danirixin + Oseltamivir matching placebo	Experimental	Drug: GSK1325756 (Danirixin), Drug: Placebo To Match Oseltamivir PhosphateSubjects will receive 75 mg oral Danirixin twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
Danirixin matching placebo + Oseltamivir matching placebo	Placebo comparator	Drug: Placebo To Match GSK1325756, Drug: Placebo To Match Oseltamivir PhosphateSubjects will receive Danirixin matching placebo twice daily with Oseltamivir matching placebo twice daily for a total of ten doses over five days
Danirixin + Oseltamivir	Experimental	Drug: GSK1325756 (Danirixin), Drug: Oseltamivir PhosphateSubjects will receive 75 mg oral Danirixin twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days
Danirixin matching placebo + Oseltamivir	Active comparator	Drug: Placebo To Match GSK1325756, Drug: Oseltamivir PhosphateSubjects will receive Danirixin matching placebo twice daily with 75 mg Oseltamivir twice daily for a total of ten doses over five days

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (17 listed)

Between 18 and 64 years of age inclusive, at the time of signing the informed consent;
Onset of influenza-like illness symptoms within 48 hours prior to study enrollment. Onset of symptoms is defined as the time when the subject's temperature was measured as elevated (>=38.0°C [>=100.4°F]) OR the time when the subject first experienced at least one symptom (cough, sore throat, nasal congestion, headache, feeling feverish, body aches and pains, or fatigue);
Subjects have an oral temperature >=38.0°C (>=100.4°F) at screening visit or history of feeling feverish within the 24 hours prior to screening visit;
At least one respiratory symptom (cough, sore throat, nasal congestion) and at least one systemic symptom (headache, body aches and pain, fatigue) due to influenza infection;
A positive influenza rapid antigen test;

Key exclusion criteria (20 listed)

Subject defined as being at high risk of complications from influenza infection according to the World Health Organization (WHO) Guidelines for Pharmacological Management of Pandemic Influenza A (H1N1) and other Influenza Viruses: Pregnant women; Persons of any age with chronic pulmonary disease (e.g. Mild persistent, Moderate or severe asthma, Chronic Obstruction Pulmonary Disease [COPD], cystic fibrosis, bronchiectasis); Persons of any age with chronic cardiac disease (e.g. congestive cardiac failure);
Persons with metabolic disorders (e.g. diabetes); Persons with chronic renal disease, chronic hepatic disease, certain neurological conditions (including neuromuscular, neurocognitive and seizure disorders, but not including autism spectrum disorders); Hemoglobinopathies, or immunosuppression, whether due to primary immunosuppressive conditions, such as Human Immunodeficiency Virus (HIV) infection, or secondary conditions, such as immunosuppressive medication or malignancy;
Subjects in whom treatment with an influenza antiviral is considered essential;
Severity of illness requiring or anticipated to require in-hospital care;
Pulse Oximetry levels <92% (at rest on room air) at screening or requirement for supplemental oxygen;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSK1325756 (Danirixin)It will be supplied as capsule shaped white film coated tablet containing 75 mg GSK1325756 for oral use	Drug	Danirixin + Oseltamivir, Danirixin + Oseltamivir matching placebo
Placebo To Match GSK1325756It will be supplied as capsule shaped white film coated placebo tablet for oral use	Drug	Danirixin matching placebo + Oseltamivir, Danirixin matching placebo + Oseltamivir matching placebo
Oseltamivir PhosphateIt will be supplied as size 0 Swedish Orange capsule containing 75 mg Oseltamivir phosphate and overfill of pre-gelatinized starch for oral use	Drug	Danirixin + Oseltamivir, Danirixin matching placebo + Oseltamivir
Placebo To Match Oseltamivir PhosphateIt will be supplied as size 0 Swedish Orange capsule containing pre-gelatinized starch and magnesium stearate for oral use	Drug	Danirixin + Oseltamivir matching placebo, Danirixin matching placebo + Oseltamivir matching placebo

Primary outcome

Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
Time frame: Up to Day 28/withdrawal
AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant.
Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Hematology parameters included Basophils, Eosinophils, Lymphocytes, Monocytes, Total neutrophils (Total ANC), Platelet count and WBC count. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Change From Baseline in Hematology Parameters- Hemoglobin
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Hematology parameters included Hemoglobin. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Change From Baseline in Hematology Parameters- Hematocrit
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Hematology parameters included Hematocrit. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH)
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Hematology parameters included Mean corpuscle hemoglobin (MCH). Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV)
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Hematology parameters included Mean corpuscle volume (MCV). Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes Count
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Hematology parameters included RBC count and Reticulocytes count. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Change From Baseline in Clinical Chemistry Parameters- Albumin and Total Protein
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Clinical chemistry parameters included Albumin and Total protein. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Change From Baseline in Clinical Chemistry- Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST) and Gamma Glutamyl Transferase (GGT)
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Clinical chemistry parameters included Alkaline phosphatase, Alanine Amino Transferase, Aspartate Amino Transferase and Gamma Glutamyl Transferase. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Change From Baseline in Clinical Chemistry Parameters- Direct Bilirubin, Total Bilirubin, Creatinine and Uric Acid
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Clinical chemistry parameters included Direct Bilirubin, Total Bilirubin, Creatinine and Uric acid. Blood samples were collected on Day 1, Day 3, Day 5 and Day28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Change From Baseline in Clinical Chemistry Parameters- Calcium, Carbon Dioxide (CO2) Content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Clinical chemistry parameters included Calcium, CO2 content/ Bicarbonate, Glucose, Potassium, Sodium and Urea/(BUN). Blood samples were collected on Day 1, Day 3, Day 5 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Change From Baseline in Urinalysis Parameters- Urine pH
Time frame: Baseline (Day 1), Day 5 and Day 28/withdrawal
Urinalysis parameters included urine pH. pH is calculated on a scale of 0 to 14, such that, the lower the number, more acidic the urine and higher the number, more alkaline the urine with 7 being neutral. Urinalysis was done on Day 1, Day 5 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Change From Baseline in Urinalysis Parameters- Urine Specific Gravity
Time frame: Baseline (Day 1), Day 5 and Day 28/withdrawal
Urinalysis parameter included Urine specific gravity and was measured on Day 1, Day 5 and Day 28. Urinary specific gravity is a measure of the concentration of solutes in the urine. It measures the ratio of urine density compared with water density and provides information on the kidney's ability to concentrate urine. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Occult Blood (Dipstick)
Time frame: Up to Day 28/withdrawal
The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine occult blood can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.
Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Glucose (Dipstick)
Time frame: Up to Day 28/withdrawal
The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine glucose can be read as negative, Trace, 1+ or 1/4 gram per deciliter (G/dL), 2+ OR 1/2 G/dL, 3+ or 1 G/dL and 4+ indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.
Number of Participants With Maximum Post-baseline Urine Dipstick Abnormalities- Urine Protein (Dipstick)
Time frame: Up to Day 28/withdrawal
The dipstick test gives results in a semi-quantitative manner, and results for urinalysis parameter of urine protein can be read as negative, Trace, 1+, 2+, 3+ and 4+, indicating proportional concentrations in the urine sample. Assessments recorded on Day 1 were considered as Baseline.
Change From Baseline in Vital Signs- Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Vital signs were measured in semi-supine position after 5 minutes rest and included systolic and diastolic blood pressure. Three readings of blood pressure were taken; the first reading was rejected and the second and third readings were averaged to give the measurement to be recorded. Vital signs were obtained on Baseline (Day 1), Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Change From Baseline in Vital Signs- Heart Rate (HR)
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Vital signs were measured in semi-supine position after 5 minutes rest and included HR. Three readings of pulse rate were taken; the first reading was rejected and the second and third readings were averaged to give the measurement to be recorded. Vital signs were obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Change From Baseline in Vital Signs- Respiration Rate (RR)
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Vital signs were measured in semi-supine position after 5 minutes rest and included RR. RR was obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Change From Baseline in Vital Signs- Temperature
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Vital signs were measured in semi-supine position after 5 minutes rest and included temperature. Oral temperature was obtained on Day 1, Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Change From Baseline in Vital Signs- Percent Oxygen in Blood (POB)
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
Vital signs were measured in semi-supine position after 5 minutes rest and included POB. POB was obtained on Baseline (Day 1), Day 3, Day 5, Day 8, Day 14 and Day 28/withdrawal. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Change From Baseline in Electrocardiogram (ECG) Parameters
Time frame: Baseline (Day 1) and up to Day 28/withdrawal
12-lead ECGs were obtained on Day 1, Day 3 and Day28/withdrawal using an ECG machine that automatically calculates and measures RR, PR, QRS, QT, and Corrected QT Interval using Bazette's formula (QTcB) and Corrected QT Interval using Fridericia forumula (QTcF) intervals. Assessments recorded on Day 1 were considered as Baseline. Change from Baseline was equal to Post-Dose Visit Value minus Baseline.
Number of Participants With Disease Related Events (DREs) of Interest
Time frame: Up to Day 28/withdrawal
Disease-related events of interest included Otitis media, Sinusitis, Bronchitis and Pneumonia and were captured separately from AEs and SAEs. DREs of interest were assessed and recorded by the site on all clinical visit days.
Number of Participants With DRE of Interest-associated Antibiotic Use
Time frame: Up to Day 28/withdrawal
Use of antibiotics for DREs of interest was monitored. Roxithromycin was used for DRE sinusitis by one participant.

9 secondary outcomes

Time to Resolution of Fever Over Time Post Initiation of Treatment
Time frame: Up to Day 28/withdrawal
Number of Afebrile Participants Over Time Post Initiation of Treatment
Time frame: Up to Day 28/withdrawal
Number of Participants Who Used Relief Medication
Time frame: Up to Day 28/withdrawal
Number of Hospital Admissions Due to Influenza Infection
Time frame: Up to Day 28/withdrawal
Change From Baseline in Influenza Viral Load as Measured by Quantitative Reverse Transcription-polymerase Chain Reaction (qRT-PCR) From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14
Time frame: Baseline (Day 1) and Day 3, Day 5, Day 8 and Day 14
Number of Participants With no Detectable Influenza Viral RNA by qRT-PCR From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14
Time frame: Up to Day 14
Total Dose of Relief Medication
Time frame: Up to Day 28/withdrawal
Change From Baseline in Influenza Viral Load as Measured by Quantitative Virus Culture From Nasopharyngeal Swabs on Day 3, Day 5, Day 8 and Day 14
Time frame: Baseline (Day 1) and Day 3, Day 5, Day 8 and Day 14
Number of Participants With no Detectable Influenza Viral RNA by Quantitative Virus Culture From Nasopharyngeal Swabs on Baseline (Day 1), Day 3, Day 5, Day 8 and Day 14
Time frame: Up to Day 14

Results and safety

Results posted to the registry on 24 Aug 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Danirixin (DNX) 75 mg	15	14
Placebo (PBO)	7	6
Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	16	14
Oseltamivir (OSV) 75 mg	7	5

Primary outcome: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

Time frame: Up to Day 28/withdrawal. Count of participants. Unit: Participants

Measure	Danirixin (DNX) 75 mg n = 15	Placebo (PBO) n = 7	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n = 16	Oseltamivir (OSV) 75 mg n = 7
AE	3	4	7	0
SAE	1	0	0	0

Population analysed: Safety population comprised of all randomized participants who received at least one dose of investigational product (IP).

Primary outcome: Change From Baseline in Hematology Parameters-Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (Total Absolute Neutrophil Count [Total ANC]), Platelet Count and White Blood Cell (WBC) Count

Time frame: Baseline (Day 1) and up to Day 28/withdrawal. Mean (Standard Deviation). Unit: Giga cells per litre (GI/L)

Measure	Danirixin (DNX) 75 Milligram (mg) n = 15	Placebo (PBO) n = 7	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n = 16	Oseltamivir (OSV) 75 mg n = 7
Basophils: Day 3	-0.011 (0.0511)	-0.002 (0.0377)	-0.008 (0.0196)	-0.008 (0.0130)
Basophils: Day 5	-0.009 (0.0569)	0.017 (0.0427)	-0.007 (0.0172)	-0.002 (0.0110)
Basophils: Day 8	-0.008 (0.0634)	0.013 (0.0356)	0.005 (0.0190)	0.008 (0.0311)
Basophils: Day 28/withdrawal	-0.007 (0.0517)	0.003 (0.0287)	0.030 (0.0520)	0.010 (0.0332)
Eosinophils: Day 3	0.017 (0.0929)	0.026 (0.0477)	-0.012 (0.1378)	-0.012 (0.0661)
Eosinophils: Day 5	0.034 (0.1048)	0.035 (0.0846)	0.012 (0.1856)	0.136 (0.3057)
Eosinophils: Day 8	0.074 (0.1248)	0.078 (0.1332)	0.036 (0.1416)	-0.000 (0.0959)
Eosinophils: Day 28/withdrawal	0.030 (0.1335)	0.163 (0.2016)	0.032 (0.1432)	-0.018 (0.0487)

Population analysed: Safety population. Only those participants available at the specified time points were analyzed.

Primary outcome: Change From Baseline in Hematology Parameters- Hemoglobin

Time frame: Baseline (Day 1) and up to Day 28/withdrawal. Mean (Standard Deviation). Unit: Grams per Litre (G/L)

Measure	Danirixin (DNX) 75 mg n = 15	Placebo (PBO) n = 7	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n = 16	Oseltamivir (OSV) 75 mg n = 7
Day 3	0.0 (6.08)	2.2 (5.78)	-4.4 (6.87)	-8.8 (9.78)
Day 5	-1.3 (6.37)	0.4 (4.96)	-5.9 (10.87)	-7.4 (11.28)
Day 8	-5.2 (6.27)	-0.6 (4.65)	-6.1 (11.65)	-7.0 (13.77)
Day 28/withdrawal	-5.9 (9.61)	-5.1 (4.49)	-10.1 (7.83)	-4.4 (12.14)

Population analysed: Safety population. Only those participants available at the specified time points were analyzed.

Primary outcome: Change From Baseline in Hematology Parameters- Hematocrit

Time frame: Baseline (Day 1) and up to Day 28/withdrawal. Mean (Standard Deviation). Unit: Fraction

Measure	Danirixin (DNX) 75 mg n = 15	Placebo (PBO) n = 7	Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg n = 16	Oseltamivir (OSV) 75 mg n = 7
Day 3	-0.0051 (0.01940)	0.0050 (0.01917)	-0.0126 (0.02310)	-0.0294 (0.03218)
Day 5	-0.0056 (0.01917)	-0.0029 (0.01734)	-0.0182 (0.03470)	-0.0250 (0.03033)
Day 8	-0.0173 (0.01958)	-0.0063 (0.01612)	-0.0176 (0.03636)	-0.0244 (0.04140)
Day 28/withdrawal	-0.0224 (0.02773)	-0.0171 (0.01933)	-0.0331 (0.02586)	-0.0136 (0.03978)

Population analysed: Safety population. Only those participants available at the specified time points were analyzed.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 28 days. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Danirixin (DNX) 75 Milligram (mg)	1 of 15 (6.7%)	1 of 15 (6.7%)	0 of 15
Placebo (PBO)	0 of 7 (0%)	2 of 7 (28.6%)	0 of 7
Danirixin (DNX) 75 mg + Oseltamivir (OSV) 75 mg	0 of 16 (0%)	3 of 16 (18.8%)	0 of 16
Oseltamivir (OSV) 75 mg	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31024969Roberts G, Chen S, Yates P, Madan A, Walker J, Washburn ML, Peat AJ, Soucie G, Kerwin E, Roy-Ghanta S. Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Clinical Effect of Danirixin in Adults With Acute, Uncomplicated Influenza. Open Forum Infect Dis. 2019 Apr 22;6(4):ofz072. doi: 10.1093/ofid/ofz072. eCollection 2019 Apr.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

33 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK1325756 (Danirixin) and Oseltamivir Phosphate in people with Virus Diseases, run by GlaxoSmithKline at 33 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in Australia, South Africa, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) (time frame: Up to Day 28/withdrawal). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02469298, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.