InfluenzaPhase 1NCT00657111
CS-8958 Single Inhaled Dose in Elderly
A Phase 1 study testing CS-8958 formulated as dry powder in people with Influenza, run by Biota Scientific Management Pty Ltd at 1 site in United Kingdom.
Trial summary
The purpose of this study is to test the safety and tolerability of an investigational inhaled flu medication, CS-8958. Study participants will include 38 elderly males and females, age 65 and older. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- CS-8958 formulated as dry powder
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2008to Oct 2009
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Ambulatory male and female adults aged 65 years and older.
- Elderly adults in good health, as determined by vital signs (heart rate less than 100 bpm, blood pressure [systolic less than or equal to 160 mm Hg and diastolic less than or equal to 90 mm Hg], oral temperature less than or equal to 37.7 degrees C and SpO2 of at least 95%), stable medical condition and a full physical examination. A stable medical condition is defined as no change in medication, dose, or frequency of medication in the last 1 month; health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months; and no unplanned hospitalizations within the last 3 months (hospitalizations for minor elective procedures may be considered for inclusion on a case by case basis following discussion between the Investigator and the DMID Medical Monitor).
- Female subjects must be surgically sterile or post-menopausal (defined by a measurement of follicle stimulating hormone [FSH] greater than 18 mlU/mL and serum oestradiol less than 110 pmol/L (or 30 pg/mL), or by 24 consecutive months of amenorrhoea for which there is no other obvious pathological cause) and have a negative serum pregnancy test.
- No clinically significant abnormality in the ECG. QTc must be less than 450 ms and PR 120-209 ms. Any ECGs considered abnormal will be reviewed and approved by an independent cardiologist, (normal variants such as sinus arrhythmia and sinus bradycardia do no need to be independently reviewed).
- Negative results in Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface antigen (HBsAg) and Hepatitis C antibody tests.
- Negative results in urine drug screen and alcohol breath test.
- Able to understand and comply with all planned study procedures including ability to perform respiratory testing and use the inhaler device after training.
- Provide informed consent prior to any study procedures and is available for all study visits.
Who cannot join
- A Grade 2 biochemistry, hematology or urinalysis abnormal finding as defined in the Appendix to the protocol. Subjects with a Grade 1 biochemistry, hematology or urinalysis abnormality will be considered for inclusion on a case by case basis following discussion between the Investigator and the DMID Medical Monitor.
- Has any malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder diagnosed or treated actively during the past 5 years.
- A history or clinical evidence of hepatic disease, including abnormal laboratory values for AST, ALT or total bilirubin or abnormal laboratory values for potassium.
- A history or clinical evidence of hematological abnormalities; specifically abnormal laboratory values for hemoglobin, platelets, WBC or neutrophils.
- A history or clinical evidence of renal disease; specifically abnormal laboratory values for serum creatinine.
- A history or clinical evidence of ventricular arrhythmias, or any subject with an implantable defibrillator.
Show all 23Show fewer
- A history or clinical evidence of significant respiratory disease (including asthma, hyper-reactive lung disease, COPD [on oral steroids or with chronic bronchitis], cystic fibrosis and/or recurrent lower respiratory tract infection, pneumonectomy or pulmonary insufficiency requiring home O2) and/or upper respiratory tract infection within the last 3 weeks or lower respiratory tract infection within the last 3 months.
- Any diagnosis of dementia (such as Alzheimer's disease) or current treatment for dementia (e.g. Aricept), or a mini mental state score of less than or equal to 25 at Screening.
- A Geriatric Depression Scale-Short Form (GDS-SF) score of greater than or equal to 6 (out of a total possible score of 15) at Screening, or a history or clinical evidence of endogenous depression, or a history or clinical evidence or treatment of exogenous depression within 1 year prior to enrollment in this study.
- A score of less than or equal to 16 out of 20 in the Clock Drawing Test (CDT) on Day 0.
- Has an acute or chronic medical condition that in the opinion of the Investigator would interfere with the evaluation of response.
- Is using parenteral or oral steroids, inhaled medications, anticoagulants, immune modulators (oral or topical) or other immunosuppressive or cytotoxic drugs within 2 weeks prior to enrolment in this study.
- Has received any other neuraminidase inhibitor within 2 weeks prior to enrollment in this study.
- A history or clinical evidence of dizziness with unknown cause.
- History of severe adverse reaction or hypersensitivity to lactose or neuraminidase inhibitors.
- Intake of any investigational drug product within 4 months prior to the intake of investigational product (Day 1).
- Receipt of blood or blood products or loss of 450 mL or more of blood during the last 3 months before screening.
- Has a clinically significant history of alcohol abuse or drug abuse.
- Body Mass Index (BMI) less than 18.5 kg/m2 or greater than 32.0 kg/m2.
- FEV1 less than or equal to 85%, FEV1.0% less than or equal to 70%, and/or FVC less than or equal to 80% of the predicted value, as calculated from standard age and height formula. If the first assessment is borderline then 2 further assessments may be made, both of which must have values above these criteria for the subject to be eligible.
- Subjects who smoke or have been non-smokers for less than 6 months prior to Screening.
- Subjects who were previously enrolled in this study.
- Poor veins or fear of venipuncture or sight of blood.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Covance Clinical Research Unit Ltd (Covance CRU)
Leeds, LS2 9LH
About this study
Official title: CS-8958 - A Phase I, Double-Blind, Placebo Controlled, Ascending Single Inhaled Dose, Safety, Tolerability and Pharmacokinetic Study in Elderly Subjects
The purpose of this study is to test the safety and tolerability of an investigational inhaled flu medication, CS-8958. Study participants will include 38 elderly males and females, age 65 and older. Participants will be divided into 1 of 4 possible treatment groups (Groups A, B, C and D) to receive the study drug or placebo (substance containing no medication). Group A will receive 5 mg CS-8958, Group B will receive 10 mg CS-8958, Group C will receive 20 mg CS-8958 and Group D will receive 40mg CS-8958. Safety information will be reviewed prior to administering a higher dose of treatment. Study procedures will include blood and urine samples, ECGs (measure of heart activity), and a 7 day clinic stay. Participants will be involved in study related procedures for up to 6 weeks.
Read the detailed description
Influenza is an acute febrile illness caused by influenza A and B virus affecting all age groups. Influenza occurs annually and each year it is estimated that influenza epidemics cause 36,000 deaths and 114,000 hospitalizations in the US alone. Influenza infections are generally self-limiting; however significant morbidity and mortality can occur, predominantly in high risk groups such as the elderly and those suffering from chronic conditions. This study is a Phase I, double-blind, placebo-controlled, ascending single inhaled dose, safety, tolerability and pharmacokinetic study in elderly subjects with stable health status. The primary objective of this study is to evaluate the safety and tolerability of CS-8958 (5, 10 20 and 40 mg) in elderly subjects after a single dose administered via inhalation. Primary outcome measures of safety and tolerability will be addressed in terms of occurrences of treatment-emergent adverse events (AEs), changes in vital signs including blood pressure and pulse rate, functional oxygen saturation of arterial hemoglobin, oral body temperature, electrocardiogram, spirometry [Forced Vital Capacity (FVC)], Forced Expiratory Volume in 1 second (FEV1), Forced Expiry Volume percentage in 1 second (FEV1.0%), Forced Expiratory Flow Rate (FEF) 25%-75%), Peak Expiratory Flow Rate (PEFR, also called PEF), physical examinations, psychological assessments, and laboratory parameters. The secondary objectives of this study are to assess the systemic exposure of CS-8958 and its active metabolite R-125489 after single inhaled doses of CS-8958 in elderly subjects. The secondary outcome measures of pharmacokinetic parameters will be calculated for CS-8958 and R-125489 (active metabolite) concentrations in plasma and urine using a non-compartmental approach. These measurements will be used to assess the systemic exposure of CS-8958 and its active metabolite in elderly subjects after a single inhaled dose of CS-8958 (5, 10, 20 and 40 mg). This data will help to determine safety margins for dosing of elderly subjects in future studies. Thirty-eight healthy adults (male and female), aged 65 years and older, with stable health status, will be recruited for this UK based study. Subjects will be studied in 4 groups (Groups A to D) with each group consisting of at least 8 subjects. Within each group, subjects will be randomly allocated to Arm 1 or Arm 2. Arm 1 will receive the investigational drug with lactose to 25 mg (placebo) and Arm 2 will receive placebo only. Treatment will begin with a low dose of 5 mg (Group A) and subsequent higher doses of 10, 20 and 40 mg (Group B, C and D, respectively) It is planned that doses will be administered in an escalating manner. The Safety Monitoring Committee will review the safety, tolerability and pharmacokinetic data from each group prior to administration of the next dose. Following these reviews, the dose increment for subsequent groups may be increased, or the doses administered may be reduced, and may be lower than the starting dose. The maximum dose level to be studied will be 40 mg. The duration of the study for each subject will be a maximum of 6 weeks from initial screen to the follow-up visit. The screening period will be at most 4 weeks followed by 7 days in the clinic and a follow up visit 5-7 days after leaving the clinic.
- Conditions
- Influenza
- Being tested
- CS-8958 formulated as dry powder, Placebo
- Keywords
- influenza, elderly, United Kingdom, Vaxart
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CS-8958 formulated as dry powderDrug
CS-8958, formulated as a dry-powder and will be administered from capsules containing 5 mg CS-8958 and lactose to 25 mg (placebo) inserted into a FlowCaps inhaler device.
PlaceboOther
placebo capsules containing 25 mg lactose
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | Subjects 01-08; 5 mg CS-8958 Receives: Drug: CS-8958 formulated as dry powder |
| A2 | Placebo comparator | Subjects 01-08; placebo Receives: Other: Placebo |
| B1 | Experimental | Subjects 09-16; 10 mg CS-8958 Receives: Drug: CS-8958 formulated as dry powder |
| B2 | Placebo comparator | Subjects 09-16; placebo Receives: Other: Placebo |
| C1 | Experimental | Subjects 17-24; 20 mg CS-8958 Receives: Drug: CS-8958 formulated as dry powder |
| C2 | Placebo comparator | Subjects 17-24; placebo Receives: Other: Placebo |
| D1 | Experimental | Subjects 25-32; 40mg CS-8958 Receives: Drug: CS-8958 formulated as dry powder |
| D2 | Placebo comparator | Subjects 25-32; placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability: treatment-emergent AEs, changes in vital signs including BP and PR, SpO2, oral body temperature, ECG, spirometry, PEFR, physical examinations, psychological assessments and laboratory parameters.
Measured: Duration of study
Secondary outcomes (1)
Pharmacokinetic parameters for CS-8958 and R-125489.
Measured: Days 1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biota Scientific Management Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas ET Lee, MBChB MRCP DGM, Principal investigator, Covance CRU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657111
- Sponsor's protocol ID
- 07-0064
- Other IDs
- CCRU 1833-174
- Status last verified
- Sep 2018
- First submitted
- 10 Apr 2008
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CS-8958 - A Phase I, Double-Blind, Placebo Controlled, Ascending Single Inhaled Dose, Safety, Tolerability and Pharmacokinetic Study in Elderly Subjects
- ClinicalTrials.gov ID
- NCT00657111
- Acronym / sponsor ID
- 07-0064
- Conditions
- Influenza
- Keywords
- influenza, elderly, United Kingdom, Vaxart
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Biota Scientific Management Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Apr 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 14 Apr 2008 (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.
The purpose of this study is to test the safety and tolerability of an investigational inhaled flu medication, CS-8958. Study participants will include 38 elderly males and females, age 65 and older. Participants will be divided into 1 of 4 possible treatment groups (Groups A, B, C and D) to receive the study drug or placebo (substance containing no medication). Group A will receive 5 mg CS-8958, Group B will receive 10 mg CS-8958, Group C will receive 20 mg CS-8958 and Group D will receive 40mg CS-8958. Safety information will be reviewed prior to administering a higher dose of treatment. Study procedures will include blood and urine samples, ECGs (measure of heart activity), and a 7 day clinic stay. Participants will be involved in study related procedures for up to 6 weeks.
Detailed description
Influenza is an acute febrile illness caused by influenza A and B virus affecting all age groups. Influenza occurs annually and each year it is estimated that influenza epidemics cause 36,000 deaths and 114,000 hospitalizations in the US alone. Influenza infections are generally self-limiting; however significant morbidity and mortality can occur, predominantly in high risk groups such as the elderly and those suffering from chronic conditions. This study is a Phase I, double-blind, placebo-controlled, ascending single inhaled dose, safety, tolerability and pharmacokinetic study in elderly subjects with stable health status. The primary objective of this study is to evaluate the safety and tolerability of CS-8958 (5, 10 20 and 40 mg) in elderly subjects after a single dose administered via inhalation. Primary outcome measures of safety and tolerability will be addressed in terms of occurrences of treatment-emergent adverse events (AEs), changes in vital signs including blood pressure and pulse rate, functional oxygen saturation of arterial hemoglobin, oral body temperature, electrocardiogram, spirometry [Forced Vital Capacity (FVC)], Forced Expiratory Volume in 1 second (FEV1), Forced Expiry Volume percentage in 1 second (FEV1.0%), Forced Expiratory Flow Rate (FEF) 25%-75%), Peak Expiratory Flow Rate (PEFR, also called PEF), physical examinations, psychological assessments, and laboratory parameters. The secondary objectives of this study are to assess the systemic exposure of CS-8958 and its active metabolite R-125489 after single inhaled doses of CS-8958 in elderly subjects. The secondary outcome measures of pharmacokinetic parameters will be calculated for CS-8958 and R-125489 (active metabolite) concentrations in plasma and urine using a non-compartmental approach. These measurements will be used to assess the systemic exposure of CS-8958 and its active metabolite in elderly subjects after a single inhaled dose of CS-8958 (5, 10, 20 and 40 mg). This data will help to determine safety margins for dosing of elderly subjects in future studies. Thirty-eight healthy adults (male and female), aged 65 years and older, with stable health status, will be recruited for this UK based study. Subjects will be studied in 4 groups (Groups A to D) with each group consisting of at least 8 subjects. Within each group, subjects will be randomly allocated to Arm 1 or Arm 2. Arm 1 will receive the investigational drug with lactose to 25 mg (placebo) and Arm 2 will receive placebo only. Treatment will begin with a low dose of 5 mg (Group A) and subsequent higher doses of 10, 20 and 40 mg (Group B, C and D, respectively) It is planned that doses will be administered in an escalating manner. The Safety Monitoring Committee will review the safety, tolerability and pharmacokinetic data from each group prior to administration of the next dose. Following these reviews, the dose increment for subsequent groups may be increased, or the doses administered may be reduced, and may be lower than the starting dose. The maximum dose level to be studied will be 40 mg. The duration of the study for each subject will be a maximum of 6 weeks from initial screen to the follow-up visit. The screening period will be at most 4 weeks followed by 7 days in the clinic and a follow up visit 5-7 days after leaving the clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: CS-8958 formulated as dry powderSubjects 01-08; 5 mg CS-8958 |
| A2 | Placebo comparator | Other: PlaceboSubjects 01-08; placebo |
| B1 | Experimental | Drug: CS-8958 formulated as dry powderSubjects 09-16; 10 mg CS-8958 |
| B2 | Placebo comparator | Other: PlaceboSubjects 09-16; placebo |
| C1 | Experimental | Drug: CS-8958 formulated as dry powderSubjects 17-24; 20 mg CS-8958 |
| C2 | Placebo comparator | Other: PlaceboSubjects 17-24; placebo |
| D1 | Experimental | Drug: CS-8958 formulated as dry powderSubjects 25-32; 40mg CS-8958 |
| D2 | Placebo comparator | Other: PlaceboSubjects 25-32; placebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (8 listed)
- Ambulatory male and female adults aged 65 years and older.
- Elderly adults in good health, as determined by vital signs (heart rate less than 100 bpm, blood pressure [systolic less than or equal to 160 mm Hg and diastolic less than or equal to 90 mm Hg], oral temperature less than or equal to 37.7 degrees C and SpO2 of at least 95%), stable medical condition and a full physical examination. A stable medical condition is defined as no change in medication, dose, or frequency of medication in the last 1 month; health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months; and no unplanned hospitalizations within the last 3 months (hospitalizations for minor elective procedures may be considered for inclusion on a case by case basis following discussion between the Investigator and the DMID Medical Monitor).
- Female subjects must be surgically sterile or post-menopausal (defined by a measurement of follicle stimulating hormone [FSH] greater than 18 mlU/mL and serum oestradiol less than 110 pmol/L (or 30 pg/mL), or by 24 consecutive months of amenorrhoea for which there is no other obvious pathological cause) and have a negative serum pregnancy test.
- No clinically significant abnormality in the ECG. QTc must be less than 450 ms and PR 120-209 ms. Any ECGs considered abnormal will be reviewed and approved by an independent cardiologist, (normal variants such as sinus arrhythmia and sinus bradycardia do no need to be independently reviewed).
- Negative results in Human Immunodeficiency Virus (HIV) antibody, Hepatitis B surface antigen (HBsAg) and Hepatitis C antibody tests.
Key exclusion criteria (23 listed)
- A Grade 2 biochemistry, hematology or urinalysis abnormal finding as defined in the Appendix to the protocol. Subjects with a Grade 1 biochemistry, hematology or urinalysis abnormality will be considered for inclusion on a case by case basis following discussion between the Investigator and the DMID Medical Monitor.
- Has any malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder diagnosed or treated actively during the past 5 years.
- A history or clinical evidence of hepatic disease, including abnormal laboratory values for AST, ALT or total bilirubin or abnormal laboratory values for potassium.
- A history or clinical evidence of hematological abnormalities; specifically abnormal laboratory values for hemoglobin, platelets, WBC or neutrophils.
- A history or clinical evidence of renal disease; specifically abnormal laboratory values for serum creatinine.
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 |
|---|---|---|
| CS-8958 formulated as dry powderCS-8958, formulated as a dry-powder and will be administered from capsules containing 5 mg CS-8958 and lactose to 25 mg (placebo) inserted into a FlowCaps inhaler device. | Drug | A1, B1, C1, D1 |
| Placeboplacebo capsules containing 25 mg lactose | Other | A2, B2, C2, D2 |
Primary outcome
Safety and tolerability: treatment-emergent AEs, changes in vital signs including BP and PR, SpO2, oral body temperature, ECG, spirometry, PEFR, physical examinations, psychological assessments and laboratory parameters.
Time frame: Duration of study
1 secondary outcome
Pharmacokinetic parameters for CS-8958 and R-125489.
Time frame: Days 1-7
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 17 Sep 2018.
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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.
Douglas ET Lee, MBChB MRCP DGM principal investigator
Covance CRU
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 CS-8958 formulated as dry powder in people with Influenza, run by Biota Scientific Management Pty Ltd at 1 site in United Kingdom.
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 8 inclusion and 23 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 17 Sep 2018. 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 Kingdom. 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?
Safety and tolerability: treatment-emergent AEs, changes in vital signs including BP and PR, SpO2, oral body temperature, ECG, spirometry, PEFR, physical examinations, psychological assessments and laboratory parameters. (time frame: Duration of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2018; AzTrials last refreshed its copy on 29 Oct 2026.