Study Evaluating Single Doses of BLI-489 in Healthy Subjects

This study is enrolling participants by invitation only.

First Received: January 9, 2009 Last Updated: March 5, 2009 History of Changes

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00820404

Purpose

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.

Condition	Intervention	Phase
Healthy Subjects	Drug: BLI-489 Drug: Placebo	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment, Safety Study
Official Title:	Ascending Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of BLI-489 Administered Intravenously to Healthy Subjects

Further study details as provided by Wyeth:

Primary Outcome Measures:

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. [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics as evaluated by drug concentrations in the blood and urine. [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	56
Study Start Date:	January 2009
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental BLI-489	Drug: BLI-489
2: Placebo Comparator Placebo	Drug: Placebo

Eligibility

Ages Eligible for Study:	20 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Men or women of nonchildbearing potential, 18 to 50 years of age inclusive at screening.
Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight greater than or equal to 50 kg.
Healthy as determined by the investigator on the basis of the screening evaluations.
Nonsmoker of smoker of fewer than 10 cigarettes per day as determined by history.

Exclusion Criteria:

Presence of history of any disorder that may prevent the successful completion of the study.
History of drug abuse within 1 year.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820404

Locations

United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19148

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	3219K1-1000
Study First Received:	January 9, 2009
Last Updated:	March 5, 2009
ClinicalTrials.gov Identifier:	NCT00820404 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 06, 2009