NCT00854009

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_1 healthy

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

First Submitted

Initial submission to the registry

February 13, 2009

Completed
7 days until next milestone

Study Start

First participant enrolled

February 20, 2009

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 2, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2009

Completed
Last Updated

September 27, 2018

Status Verified

September 1, 2018

Enrollment Period

1 month

First QC Date

February 13, 2009

Last Update Submit

September 25, 2018

Conditions

Healthy

Keywords

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
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men, aged 20 to 50 years of age inclusive at screening.
  • Body mass index (BMI) in the range of 17.6 to 26.4 kg/m2 and body weight ≥45 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

Tokyo, 1710014, Japan

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
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2009

First Posted

March 2, 2009

Study Start

February 20, 2009

Primary Completion

April 1, 2009

Study Completion

April 27, 2009

Last Updated

September 27, 2018

Record last verified: 2018-09

Locations

JP(1)