Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing

• Sponsor: ViiV Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02805556
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 36
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.7
• Patients Per Site Per Month: 21.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infection, Human Immunodeficiency Virus	Drug: BMS-663068; Drug: BMS-626529	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: N/A
• 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
• Actual Study Start Date: Mar 15, 2016
• Actual Primary Completion Date: May 5, 2016
• Actual Study Completion Date: May 5, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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) [up to 11 days]

Secondary Outcome Measures

1. 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 [up to 31 days]

2. 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 [up to 31 days]

Eligibility Criteria

Criteria

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

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

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Lisburn		United Kingdom	BT 28 2 RF

Sponsors and Collaborators

• ViiV Healthcare
• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, ViiV Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: ViiV Healthcare
• ClinicalTrials.gov Identifier: NCT02805556
• Other Study ID Numbers: 206218; AI438-075
• First Posted: Jun 20, 2016
• Last Update Posted: Jul 21, 2017
• Last Verified: Jul 1, 2017

• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Fostemsavir

Study Results

No Results Posted as of Jul 21, 2017