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

Healthy Clinical Trial

Official title:

Ascending Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of BLI-489 Administered Intravenously to Healthy Japanese Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00854009
• Other study ID #: 3219K1-1004
• Status: Completed
• Phase: Phase 1
• Start date: February 20, 2009
• Est. completion date: April 27, 2009

Study information

• Verified date: September 2018
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 27, 2009
• Est. primary completion date: April 1, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BLI-489

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics as evaluated by drug concentrations in the blood and urine.		4 days