Infections, Respiratory TractPhase 1NCT02202187

A Single Oral Escalating Dose Study of GSK2140944 in Healthy Volunteers

A Phase 1 study testing GSK2140944 in people with Infections, Respiratory Tract, run by GlaxoSmithKline at 1 site in United States.

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 60 yearsHealthy volunteers can take part
Conditions the study is for: Infections, Respiratory Tract
What is being tested?: GSK2140944
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 1 siteUnited States
Study dates: 26 Sep 2011to 15 Feb 2012
Phase: Phase 1
Are there results?: None posted in the registry

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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Male or female ranging from 18 to 60 years of age, at the time of signing the informed consent. Female subject must be of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/mL (<147 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
Body weight ≥ 50 kg and BMI within the range 19 - 31 kg/m2, inclusive.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
QTcF < 450 msec, or QTc < 480 msec in subjects with Bundle Branch Block., at screening.

Who cannot join

Any clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of such conditions that, in the opinion of the investigator may place the subject at an unacceptable risk as a participant in this trial or may interfere with the absorption, distribution, metabolism or excretion of drugs.
A positive urine test for drugs of abuse or alcohol (or alcohol breath test) at screening.
A screening urinalysis positive for protein or glucose (greater than "trace" findings of protein or glucose).
Positive for Human Immunodeficiency Virus (HIV) antibody, hepatitis B virus surface antigen, or hepatitis C virus antibody at screening.
History of drug abuse within 6 months of the study.
History of smoking or use of nicotine containing products within 3 months of screening, or a positive urine cotinine indicative of smoking at screening.

Show all 15Show fewer

History of regular alcohol consumption exceeding an average weekly intake of greater than or equal to 21 units for men/14 units for women or an average daily intake of greater than or equal to 3 units for men/2 units for women. One unit is equivalent to a 285 mL glass of full strength beer or 425 mL schooner of light beer or 1 (30 mL) measure of spirits or 1 glass (100 mL) of wine.
The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication.
Use of prescription or non-prescription drugs, including vitamins above the recommended daily intake (National Health and Medical Research Council in Australia guideline), herbal and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, or use of St. John's Wort within 14 days prior to the first dose of study medication. By exception, the volunteer may take paracetamol or acetaminophen (≤ 2 grams/day) or ibuprofen (1600 mg/day) up to 48 hours prior to the first dose of study medication. However, the investigator and study team can review medication use on a case by case basis to determine if its use would compromise subject safety or interfere with study procedures or data interpretation.
Consumption of red wine, seville oranges, grapefruit or grapefruit juice, pummelos, exotic citrus fruits or grapefruit hybrids or fruit juices containing such products for 7 days prior to administration of study medication.
Donation of blood in excess of 550 mL within 12 weeks prior to dosing.
An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women, or an unwillingness of male subjects to use a condom and spermicide, in addition to having their female partner use another form of contraception such as an IUD, diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation, if engaging in sexual intercourse with a female partner who could become pregnant. This criterion must be followed from the time of study medication administration and until 84 days after study medication administration.
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 physician responsible, contraindicates their participation.
History of sensitivity to heparin or heparin-induced thrombocytopenia (if the clinical research unit uses heparin to maintain intravenous cannula patency).
An unwillingness to comply with lifestyle and/or dietary restrictions as described in Section 8.

Trial locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Minneapolis, Minnesota, 55404

Other trials in United States

About this study

Official title: A Randomized, Single Blind, Placebo Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Escalating Oral Doses of GSK2140944 in Healthy Adult Subjects

GSK2140944 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of antibiotics. GSK2140944 has demonstrated in vitro and in vivo activity against Gram positive including methicillin resistant Staphylococcus aureus (MRSA) and Gram-negative pathogens associated with respiratory tract, skin and soft tissue infections including isolates resistant to existing classes of antimicrobials. This is a First Time in Human (FTIH) study to assess the safety, tolerability, and pharmacokinetics of single oral doses of GSK2140944 in healthy volunteers. This study will be a single-blind, randomized, placebo-controlled, dose-rising study in healthy subjects. The proposed single doses will range from 100 mg to 3000 mg.

Read the detailed description

GSK2140944 belongs to the Bacterial Type II Topoisomerase Inhibitor (BTI) class of antibiotics which is being developed for treatment of Gram positive [including methicillin resistant Staphylococcus aureus (MRSA)] and Gram-negative pathogens associated with respiratory tract and skin and soft tissue infections including isolates resistant to existing classes of antimicrobials.

Study BTZ114595 will be the first administration of GSK2140944 in humans. This study will examine the safety, tolerability, and pharmacokinetics of escalating single oral doses of GSK2140944. The predicted clinical target for efficacy, based on preclinical efficacy models, is an AUC(0-24) of 16-30 μg.h/mL. This study aims to explore the safety and tolerability at and above target exposures in order to establish a therapeutic window for this compound.

This study will investigate the safety, tolerability, and pharmacokinetics of escalating single oral doses of GSK2140944.

This will be a randomized, placebo-controlled, single-blind study to determine safety, tolerability, and single dose pharmacokinetic (PK) profile of GSK2140944 in healthy subjects.

The projected single escalating doses of GSK2140944 will range from a starting dose of 100 mg to a maximum dose of 3000 mg. The current plan is to administer the study drug after an overnight fast, but based on emerging PK and safety data, it may be necessary to administer the study drug under fed state to better understand safety, tolerability or PK of GSK2140944. Any decision to remove or modify fasting requirements will be made by the GSK Study Team and the investigator based on joint review of the emerging safety, tolerability and preliminary pharmacokinetic data from prior dose-levels.

Conditions: Infections, Respiratory Tract
Being tested: GSK2140944, Placebo
Medical subject headings: Respiratory Tract Infections

What participants receive

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

GSK2140944Drug
Investigational Study Drug
PlaceboOther
Placebo

Study groups in NCT02202187
Study group	Role	What they receive
GSK2140944	Experimental	Dose range 100mg to 3000mg single dose Receives: Drug: GSK2140944
Matching Placebo	Placebo comparator	Placebo Receives: Other: Placebo

What is being measured

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

GSK2140944 clinical safety data assessed as change from baseline in 12-lead ECG
12-lead ECGs will be obtained at each timepoint using an ECG machine, after the subject has rested in the supine position for at least 10 minutes
Measured: Day 1, Day 2, Day 3 and at the Follow-up visit
GSK2140944 clinical safety data from dual-lead cardiac monitoring
Continuous dual-lead cardiac monitoring will be obtained at each timepoints using an ECG machine
Measured: Day -1, Day 1
GSK2140944 clinical safety data assessed as change from baseline in clinical laboratory tests
Clinical laboratory assessments will include hematology, clinical chemistry, routine urinalysis and additional parameters
Measured: Day -1, Day 2, Day 3 and the Follow-up visit
GSK2140944 clinical safety data assessed as by number of adverse events (AE)
Safety and tolerability parameters will include recording of AEs, throughout the study
Measured: Up to the Follow-up visit
GSK2140944 clinical safety data assessed as change from baseline in blood pressure
Vital sign measurements will include systolic and diastolic blood pressure
Measured: Day -1, Day 1, Day 2, Day 3 and the Follow-up visit
GSK2140944 clinical safety data assessed as change from baseline in heart rate
Vital sign measurements will include pulse rate
Measured: Day -1, Day 1, Day 2, Day 3 and the Follow-up visit

Secondary outcomes (9)

Pharmacokinetic parameter: AUC(0-t) following single dose of GSK2140944
Pharmacokinetic data will include area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-t)) following single dose of GSK2140944
Measured: Up to Day 4
Pharmacokinetic parameter: AUC(0-infinity) following single dose of GSK2140944
Pharmacokinetic data will include area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC(0-infinity)) following single dose of GSK2140944
Measured: Up to Day 4
Pharmacokinetic parameter: Cmax following single dose of GSK2140944
Pharmacokinetic data will include maximum observed concentration (Cmax) following single dose of GSK2140944
Measured: Up to Day 4
Pharmacokinetic parameter: tmax following single dose of GSK2140944
Pharmacokinetic data will include time of occurrence of Cmax (tmax) following single dose of GSK2140944
Measured: Up to Day 4
Pharmacokinetic parameter: t1/2 following single dose of GSK2140944
Pharmacokinetic data will include terminal phase half-life (t1/2) following single dose of GSK2140944
Measured: Up to Day 4
To assess preliminary dose proportionality using PK parameter AUC(0-infinity) following single dose of GSK2140944
Preliminary dose proportionality will be assessed using PK parameter (AUC(0-infinity)) following single dose of GSK2140944
Measured: Up to Day 4
To assess preliminary dose proportionality using PK parameter Cmax following single dose of GSK2140944
Preliminary dose proportionality will be assessed using PK parameter Cmax following single dose of GSK2140944
Measured: Up to Day 4
Pharmacokinetic parameter: (Ae) following single dose of GSK2140944
Pharmacokinetic data will include urinary recovery of unchanged drug (Ae) following single dose of GSK2140944
Measured: Up to Day 4
Pharmacokinetic parameter: (CLr) following single dose of GSK2140944
Pharmacokinetic data will include renal clearance (CLr) following single dose of GSK2140944
Measured: Up to Day 4

Timeline

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

26 Sep 201115 Feb 2012

First posted28 Jul 2014 (estimated)
Study start26 Sep 2011
Primary completion15 Feb 2012
Study completion15 Feb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Infections, Respiratory TractStudies 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 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02202187
Sponsor's protocol ID: 114595
Status last verified: Jun 2017
First submitted: 29 Mar 2012
Last updated: 12 Jun 2017
Results posted: No

Publications

Tiffany C, Dumont EF, Hossain M, Srinivasan M, Swift B. Pharmacokinetics, safety, and tolerability of gepotidacin administered as single or repeat ascending doses, in healthy adults and elderly subjects. Clin Transl Sci. 2022 Sep;15(9):2251-2264. doi: 10.1111/cts.13359. Epub 2022 Jul 13.
PubMed 35769034

Want to know more?

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.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Single Blind, Placebo Controlled Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single Escalating Oral Doses of GSK2140944 in Healthy Adult Subjects
ClinicalTrials.gov ID: NCT02202187
Acronym / sponsor ID: 114595
Conditions: Infections, Respiratory Tract
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 26 Sep 2011 (actual)
Primary completion: 15 Feb 2012 (actual)
Study completion: 15 Feb 2012 (actual)
First posted: 28 Jul 2014 (estimated)
Results: Not posted in the source record

Clinical summary

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

Detailed description

This study will investigate the safety, tolerability, and pharmacokinetics of escalating single oral doses of GSK2140944.

This will be a randomized, placebo-controlled, single-blind study to determine safety, tolerability, and single dose pharmacokinetic (PK) profile of GSK2140944 in healthy subjects.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
GSK2140944	Experimental	Drug: GSK2140944Dose range 100mg to 3000mg single dose
Matching Placebo	Placebo comparator	Other: PlaceboPlacebo

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

AST, ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Male or female ranging from 18 to 60 years of age, at the time of signing the informed consent. Female subject must be of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/mL (<147 pmol/L) is confirmatory]. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in Section 8.1 if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
Body weight ≥ 50 kg and BMI within the range 19 - 31 kg/m2, inclusive.
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Key exclusion criteria (15 listed)

Any clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of such conditions that, in the opinion of the investigator may place the subject at an unacceptable risk as a participant in this trial or may interfere with the absorption, distribution, metabolism or excretion of drugs.
A positive urine test for drugs of abuse or alcohol (or alcohol breath test) at screening.
A screening urinalysis positive for protein or glucose (greater than "trace" findings of protein or glucose).
Positive for Human Immunodeficiency Virus (HIV) antibody, hepatitis B virus surface antigen, or hepatitis C virus antibody at screening.
History of drug abuse within 6 months of the study.

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
GSK2140944Investigational Study Drug	Drug	GSK2140944
PlaceboPlacebo	Other	Matching Placebo

Primary outcome

GSK2140944 clinical safety data assessed as change from baseline in 12-lead ECG
Time frame: Day 1, Day 2, Day 3 and at the Follow-up visit
12-lead ECGs will be obtained at each timepoint using an ECG machine, after the subject has rested in the supine position for at least 10 minutes
GSK2140944 clinical safety data from dual-lead cardiac monitoring
Time frame: Day -1, Day 1
Continuous dual-lead cardiac monitoring will be obtained at each timepoints using an ECG machine
GSK2140944 clinical safety data assessed as change from baseline in clinical laboratory tests
Time frame: Day -1, Day 2, Day 3 and the Follow-up visit
Clinical laboratory assessments will include hematology, clinical chemistry, routine urinalysis and additional parameters
GSK2140944 clinical safety data assessed as by number of adverse events (AE)
Time frame: Up to the Follow-up visit
Safety and tolerability parameters will include recording of AEs, throughout the study
GSK2140944 clinical safety data assessed as change from baseline in blood pressure
Time frame: Day -1, Day 1, Day 2, Day 3 and the Follow-up visit
Vital sign measurements will include systolic and diastolic blood pressure
GSK2140944 clinical safety data assessed as change from baseline in heart rate
Time frame: Day -1, Day 1, Day 2, Day 3 and the Follow-up visit
Vital sign measurements will include pulse rate

9 secondary outcomes

Pharmacokinetic parameter: AUC(0-t) following single dose of GSK2140944
Time frame: Up to Day 4
Pharmacokinetic parameter: AUC(0-infinity) following single dose of GSK2140944
Time frame: Up to Day 4
Pharmacokinetic parameter: Cmax following single dose of GSK2140944
Time frame: Up to Day 4
Pharmacokinetic parameter: tmax following single dose of GSK2140944
Time frame: Up to Day 4
Pharmacokinetic parameter: t1/2 following single dose of GSK2140944
Time frame: Up to Day 4
To assess preliminary dose proportionality using PK parameter AUC(0-infinity) following single dose of GSK2140944
Time frame: Up to Day 4
To assess preliminary dose proportionality using PK parameter Cmax following single dose of GSK2140944
Time frame: Up to Day 4
Pharmacokinetic parameter: (Ae) following single dose of GSK2140944
Time frame: Up to Day 4
Pharmacokinetic parameter: (CLr) following single dose of GSK2140944
Time frame: Up to Day 4

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
Derived from this study: PubMed 35769034Tiffany C, Dumont EF, Hossain M, Srinivasan M, Swift B. Pharmacokinetics, safety, and tolerability of gepotidacin administered as single or repeat ascending doses, in healthy adults and elderly subjects. Clin Transl Sci. 2022 Sep;15(9):2251-2264. doi: 10.1111/cts.13359. Epub 2022 Jul 13.
Results for study 114595 can be found on the GSK Clinical Study Register.Link provided by the sponsor.

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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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK2140944 in people with Infections, Respiratory Tract, run by GlaxoSmithKline at 1 site in United States.

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 6 inclusion and 15 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 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

GSK2140944 clinical safety data assessed as change from baseline in 12-lead ECG (time frame: Day 1, Day 2, Day 3 and at the Follow-up visit). The study lists 6 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 NCT02202187, 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 12 Jun 2017.