Study Evaluating Single Doses of BLI-489 in Healthy Japanese Male Subjects

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BLI-489; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00854009

3219K1-1004

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of single doses of BLI-489 administered intravenously in healthy Japanese male subjects, and how the drug is absorbed and eliminated.

Enrollment: 40 patients

Sex: Male

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Men, aged 20 to 50 years of age 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 the screening evaluations.
4. Nonsmoker of smoker of fewer than 10 cigarettes per day as determined by history.

Exclusion criteria

1. Presence of history of any disorder that may prevent the successful completion of the study.
2. 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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40 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

BLI-489

Treatment:

Drug: BLI-489

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo