Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HSD-016

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: HSD-016; Other: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00739232

3248A1-1000

Details and patient eligibility

About

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.

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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74 participants in 2 patient groups, including a placebo group

Active

Active Comparator group

Description:

Active

Treatment:

Drug: HSD-016

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: placebo