Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Wyeth |
---|---|
Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00739232 |
This is a single ascending dose study of HSD-016 to provide the initial assessment of the safety, tolerability, how the drug is absorbed and eliminated, and its effect on the body.
Condition | Intervention | Phase |
---|---|---|
Healthy Subjects |
Drug: HSD-016 Other: placebo |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety Study |
Official Title: | Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HSD-016 Administered Orally to Healthy Subjects |
Estimated Enrollment: | 74 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active: Active Comparator
Active
|
Drug: HSD-016 |
Placebo: Placebo Comparator
Placebo
|
Other: placebo |
Ages Eligible for Study: | 18 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion:
Exclusion:
Contact: Trial Manager | clintrialparticipation@wyeth.com |
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 3248A1-1000 |
Study First Received: | August 20, 2008 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00739232 |
Health Authority: | United States: Food and Drug Administration |
Safety and tolerability of HSD-016 |
Healthy |