Study Evaluating the Safety, Pharmacokinetics (PK), and Pharmacodynamices (PD) of HSD-016

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: placebo; Drug: HSD-016

Study type: Interventional

Funder types: Industry

Identifiers

NCT00838461

3248A1-1002

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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32 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

HSD-016

Treatment:

Drug: HSD-016

2

Placebo Comparator group

Description:

placebo

Treatment:

Drug: placebo