Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing

July 18, 2017 updated by: ViiV Healthcare

Study of the Absolute Bioavailability of BMS-626529 in Healthy Subjects Following Oral Dosing of BMS-663068 and Intravenous Dosing of BMS-626529

A phase I absolute bioavailability study of BMS-626529 following oral and intravenous dosing

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

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

  • United Kingdom
      • Lisburn, United Kingdom, BT 28 2 RF
        • GSK Investigational Site

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Generally healthy
  • BMI 18.0-32.0 kg/m2
  • Men sexually active with women of childbearing potential must follow instructions for contraception for the duration of treatment plus 90 days
  • Men must refrain from sperm donation for the length of the study and for 90 days
  • Sign informed consent

Exclusion Criteria:

  • Significant medical illness
  • Tobacco use in the last 12 months
  • Major surgery within 4 weeks of study administration
  • Donation of blood within 4 weeks of study administration
  • Current or recent (within 3 months of study administration) of gastrointestinal disease

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral dose of BMS-663068 + intravenous dose of [13C]BMS 626529
Single oral dose of BMS-663068 followed by Single intravenous dose of [13C]BMS 626529
Drug: BMS-663068
Single oral dose of BMS-663068
Drug: BMS-626529
Single intravenous dose of [13C]BMS 626529

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The absolute bioavailability of BMS-626529 after single oral (BMS-663068) and single intravenous dosing ([13C]-BMS-626529) by assessing the primary endpoints AUC(inf)
Time Frame: up to 11 days
up to 11 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of single oral dose of BMS-663068 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests
Time Frame: up to 31 days
up to 31 days
Safety and tolerability of single intravenous dose of [13C]-BMS-626529 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests
Time Frame: up to 31 days
up to 31 days

Collaborators and Investigators

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

Sponsor

ViiV Healthcare

Collaborators

GlaxoSmithKline

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)

March 15, 2016

Primary Completion (Actual)

May 5, 2016

Study Completion (Actual)

May 5, 2016

Study Registration Dates

First Submitted

May 31, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimate)

June 20, 2016

Study Record Updates

Last Update Posted (Actual)

July 21, 2017

Last Update Submitted That Met QC Criteria

July 18, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 206218
  • AI438-075 (Other Identifier: Bristol-Myers Squibb)

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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