Study Evaluating Single Doses of BLI-489 in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820404
• Other study ID #: 3219K1-1000
• Status: Completed
• Phase: Phase 1
• First received: January 9, 2009
• Last updated: July 16, 2009
• Start date: January 2009
• Est. completion date: April 2009

Study information

• Verified date: July 2009
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• 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 subjects, and also how the drug is absorbed and eliminated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Men or women of nonchildbearing potential, 18 to 50 years of age inclusive at screening.

2. Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to 50 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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

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

United States, 

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	Yes
Secondary	Pharmacokinetics as evaluated by drug concentrations in the blood and urine.		4 days	No