Healthy Subjects Clinical Trial
Official title:
Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HSD-016 Administered Orally to Healthy Subjects
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.
Status | Completed |
Enrollment | 74 |
Est. completion date | February 2009 |
Est. primary completion date | February 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion: 1. Men or women of nonchildbearing potential aged 18 to 50 years inclusive at screening. 2. Healthy as determined by the investigator on the basis of screening evaluations. 3. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Exclusion: 1. No presence or history of any disorder that may prevent the successful completion of the study. 2. No history of drug abuse within 1 year. |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Wyeth is now a wholly owned subsidiary of Pfizer |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and Tolerability | 3 months | Yes | |
Secondary | Profiles of Drug Concentrations | 3 months | No |
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