Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing
Primary Purpose
Infection, Human Immunodeficiency Virus
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
BMS-663068
BMS-626529
Sponsored by
About this trial
This is an interventional treatment trial for Infection, Human Immunodeficiency Virus
Eligibility Criteria
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
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oral dose of BMS-663068 + intravenous dose of [13C]BMS 626529
Arm Description
Single oral dose of BMS-663068 followed by Single intravenous dose of [13C]BMS 626529
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT02805556
First Posted
May 31, 2016
Last Updated
July 18, 2017
Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
1. Study Identification
Unique Protocol Identification Number
NCT02805556
Brief Title
Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing
Official Title
Study of the Absolute Bioavailability of BMS-626529 in Healthy Subjects Following Oral Dosing of BMS-663068 and Intravenous Dosing of BMS-626529
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
March 15, 2016 (Actual)
Primary Completion Date
May 5, 2016 (Actual)
Study Completion Date
May 5, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ViiV Healthcare
Collaborators
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
A phase I absolute bioavailability study of BMS-626529 following oral and intravenous dosing
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection, Human Immunodeficiency Virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral dose of BMS-663068 + intravenous dose of [13C]BMS 626529
Arm Type
Experimental
Arm Description
Single oral dose of BMS-663068 followed by Single intravenous dose of [13C]BMS 626529
Intervention Type
Drug
Intervention Name(s)
BMS-663068
Intervention Description
Single oral dose of BMS-663068
Intervention Type
Drug
Intervention Name(s)
BMS-626529
Intervention Description
Single intravenous dose of [13C]BMS 626529
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
ViiV Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Lisburn
ZIP/Postal Code
BT 28 2 RF
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing
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