Healthy Subjects
Conditions
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 subjects.
Interventions
DRUGHSD-016
DRUGplacebo
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion: 1. Men, aged 20 to 45 years inclusive at screening. 2. Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 kg 3. Healthy as determined by the investigator on the basis of screening evaluations. 4. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| clinical labs, adverse events | 6 months |
Countries
Japan
Outcome results
None listed