Status:
COMPLETED
Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of HSD-016
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Healthy Subjects
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
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 it's effect on the body in Japanese male su...
Eligibility Criteria
Inclusion
- Inclusion:
- Men, aged 20 to 45 years inclusive at screening.
- Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg
- Healthy as determined by the investigator on the basis of screening evaluations.
- Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history.
- Exclusion:
- No presence or history of any disorder that may prevent the successful completion of the study.
- No history of drug abuse within 1 year.
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00740649
Start Date
October 1 2008
End Date
March 1 2009
Last Update
March 31 2009
Active Locations (1)
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1
Toshima-ku, Tokyo, Japan, 171-0014