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

September 25, 2018 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan, 1710014

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Placebo
Drug: Placebo
Experimental: 1
BLI-489
Drug: BLI-489

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
15 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics as evaluated by drug concentrations in the blood and urine.
Time Frame: 4 days
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2009

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 27, 2009

Study Registration Dates

First Submitted

February 13, 2009

First Submitted That Met QC Criteria

February 27, 2009

First Posted (Estimate)

March 2, 2009

Study Record Updates

Last Update Posted (Actual)

September 27, 2018

Last Update Submitted That Met QC Criteria

September 25, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3219K1-1004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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