Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of HSD-016

Wyeth is now a wholly owned subsidiary of Pfizer74 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy Subjects

Interventions

HSD-016DRUG

placeboDRUG

Eligibility

Sex: MALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Toshima-ku, Tokyo, Japan

Outcomes

Primary Outcomes

clinical labs, adverse events

Time frame: 6 months

Data from ClinicalTrials.gov

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