Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00311714
Status:
COMPLETED
Last Update Posted:
2018-05-30
First Post:
2006-04-05
Brief Title:
Safety Tolerability and Pharmacokinetic Study of Biota-CS-8958
Sponsor:
Biota Scientific Management Pty Ltd
Organization:
Vaxart
Study Overview
Official Title:
CS-8958 - A Phase I Double-Blind Placebo-Controlled Ascending Single Inhaled Dose Safety Tolerability and Pharmacokinetic Study in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will look at the safety tolerability and what the body does to CS-8958 given to 40 healthy volunteers 18-55 years old CS-8958 is a dry-powder investigational drug that is breathed into the lungs through an inhaler device The researchers will collect information about any problems that volunteers have while taking the drug and about changes in blood pressure and how the heart is working Volunteers will have breathing tests physical examinations and blood samples collected for laboratory tests The researchers will also look at how much of the medication travels throughout the body versus how much stays only in the lungs Doses of the medication will be tested at one level and then at higher and higher levels after a safety committee reviews the safety and tolerability information on volunteers prior to the next higher dose being given Each volunteer will participate for up to 6 weeks from initial screening to the follow up visit and spend 7 days in the clinic
Detailed Description:
This study is a phase I double-blind placebo-controlled ascending single inhaled dose safety tolerability and pharmacokinetic study of CS-8958 in healthy subjects CS-8958 is an investigational drug substance which is formulated as a dry-powder Capsules of the dry powder are inserted into a FlowCaps inhaler device FlowCaps is a re-fillable dry-powder breath-actuated inhaler device which holds up to 14 capsules Upon actuation the powder contained in one capsule is delivered to the respiratory tract The primary study objective is to evaluate the safety and tolerability of CS-8958 5 10 20 and 40 mg in healthy subjects after a single dose administered via inhalation Parameters are adverse events AEs vital signs including blood pressurepulse rate BPPR measurements functional oxygen saturation of arterial haemoglobin SpO2 electrocardiogram ECG examinations spirometry Forced Vital Capacity FVC Forced Expiratory Volume in 1 second FEV1 FEV percentage in 1 second FEV 1 FEV1FVC ratio Forced Expiratory Flow Rate FEF 25-75 Peak Expiratory Flow Rate PEFR physical examinations mood assessments and laboratory parameters The secondary study objective is to assess the systemic exposure of CS-8958 and its active metabolite R-125489 after single inhaled doses of CS-8958 in healthy subjects At Covance Clinical Research Unit Ltd Leeds UK 40 subjects will be studied in 4 groups Groups A to D with each group consisting of 10 subjects Healthy male and female subjects aged 18-55 years inclusive will be recruited for the study There will be four investigational product treatment groups Groups A B C and D Within each group subjects will be randomly allocated to Arm 1 or Arm 2 The study product doses will be administered in an escalating manner The Safety Monitoring Committee SMC will review the safety and tolerability 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 primary outcome measures include safety and tolerability These outcome measures will be addressed in terms of occurrences of treatment-emergent AEs changes in vital signs including BP and PR SpO2 oral body temperature ECG spirometry FVC FEV1 FEV 1 FEV1FVC ratio FEF 25-75 and PEFR physical examinations mood assessments and laboratory parameters Secondary outcome measures will include pharmacokinetic parameters These parameters will be calculated for CS-8958 and R-125489 concentrations in plasma and urine using a non-compartmental approach
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1833-094 | None | None | None |