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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BLI-489; Drug: Placebo

• Registration Number: NCT00854009
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-13
• Study Start: 2009-02-20
• Study First Submitted QC: 2009-02-27
• Study First Posted: 2009-03-02
• Primary Completion: 2009-04-01
• Study Completion: 2009-04-27
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-25
• Last Update Posted: 2018-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	BLI-489	BLI-489
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Safety as measured by the number of adverse events and serious adverse events. Tolerability will be assessed based upon the occurrence of dose limiting toxicities.	15 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics as evaluated by drug concentrations in the blood and urine.	4 days