Healthy Subjects
Conditions
Brief summary
This is intended to provide an initial safety assessment of HSD-016 and also to evaluate how the drug is absorbed and eliminated and its effect on the body in healthy 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
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men or women of nonchildbearing potential aged 18 to 50 years. 2. Healthy as determined by investigator on the basis of medical history and physical examination, laboratory test results, and 12-lead ECG. 3. Nonsmoker or smoker of fewer than 10 cigarettes per day.
Exclusion criteria
1. No history of thyroid abnormalities. 2. No presence or history of any disorder that may prevent the successful completion of the study. 3. No history of drug abuse. 4. No use of any systemic steroids for 3 months. 5. No history of claustrophobia.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety will be evaluated from reported AEs, scheduled physical, vital sign measurements, 12 lead ECGs, and clinical laboratory test results. | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Levels of drug concentrations will be evaluated after receiving multiple doses of HSD-016 | 3 months |
Countries
United States
Outcome results
None listed