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Clinical Trials

MainTitle

Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing

This study has been completed
Sponsor
ViiV Healthcare

Collaborator
GlaxoSmithKline

Information provided by (Responsible Party)
ViiV Healthcare
ClinicalTrials.gov Identifier
NCT02805556

First received: May 31, 2016
Last updated: July 18, 2017
Last Verified: July 2017
History of Changes
Purpose

Purpose

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

Condition Intervention Phase
Infection, Human Immunodeficiency Virus

Drug : BMS-663068
Drug : BMS-626529
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by ViiV Healthcare:

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) [ Time Frame: up to 11 days ]
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 [ Time Frame: 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 ]

Enrollment: 36
Study Start Date: March 15, 2016
Study Completion Date: May 5, 2016
Primary Completion Date: May 5, 2016 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
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

Eligibility

Eligibility

Ages Eligible for Study: 18 Years to 50 Years  
Sexes Eligible for Study: Male  
Accepts Healthy Volunteers: Yes  

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02805556

Locations

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

Sponsors and Collaborators

ViiV Healthcare
GlaxoSmithKline

Investigators

Study Director: GSK Clinical Trials ViiV Healthcare
More Information

More Information


Responsible Party: ViiV Healthcare  
ClinicalTrials.gov Identifier: NCT02805556   History of Changes  
Other Study ID Numbers: 206218  
  AI438-075  
Study First Received: May 31, 2016  
Last Updated: July 18, 2017  

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections

ClinicalTrials.gov processed this data on October 20, 2017
This information is provided by ClinicalTrials.gov.