Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (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

NCT00740649

3248A1-1001

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 it's effect on the body in Japanese male subjects.

Enrollment: 74 estimated patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

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

1

Experimental group

Description:

HSD-016

Treatment:

Drug: HSD-016

2

Other group

Description:

placebo

Treatment:

Drug: placebo