NCT00820404

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

July 17, 2009

Status Verified

July 1, 2009

Enrollment Period

3 months

First QC Date

January 9, 2009

Last Update Submit

July 16, 2009

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Pharmacokinetics as evaluated by drug concentrations in the blood and urine.

    4 days

Study Arms (2)

1

EXPERIMENTAL

BLI-489

Drug: BLI-489

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

BLI-489DRUG
1
PlaceboDRUG
2

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Philadelphia, Pennsylvania, 19148, United States

Location

MeSH Terms

Interventions

BLI-489

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 9, 2009

First Posted

January 12, 2009

Study Start

January 1, 2009

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

July 17, 2009

Record last verified: 2009-07

Locations

US(1)