A Study to Evaluate the Effect of BMS-955176 on Pharmacokinetics of Dolutegravir and the Effect of Dolutegravir on the Pharmacokinetics of BMS-955176

NCT02715479 | Completed Phase 1

• 2 other identifiers: 206222AI468-052
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate how BMS955176 affects pharmacokinetics (PK) of Dolutegravir (DTG) and also how DTG administration affects the PK of BMS955176

Conditions

Infection, Human Immunodeficiency Virus

Outcome Measures

Primary Outcomes (4)

• Maximum observed plasma concentration (Cmax) for DTG

  Days 1 to 5 and days 15 to 21

• Area under the concentration-time curve in 1 dosing interval AUC (tau) for DTG

  Days 1 to 5 and days 15 to 21

• Maximum observed plasma concentration (Cmax) for BMS-955176

  Days 8-21

• Area under the concentration-time curve in 1 dosing interval AUC (tau) for BMS-955176

  Days 8-21

Secondary Outcomes (1)

• Adverse events (AEs)

  Days 1-21; for SAEs up to 30 days post discontinuation of dosing

Study Arms (3)

Treatment A

EXPERIMENTAL

Single DTG tablet under fed conditions for a specified period

Drug: Dolutegravir

Treatment B

EXPERIMENTAL

Two BMS955176 tablets under fed conditions for a specified period

Drug: BMS955176

Treatment C

EXPERIMENTAL

Single DTG tablet and Two BMS955176 tablets under fed conditions for a specified period

Drug: Dolutegravir; Drug: BMS955176

Interventions

Dolutegravir DRUG

Dolutegravir

Treatment A; Treatment C

BMS955176 DRUG

BMS955176

Treatment B; Treatment C

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed Informed Consent
• Target population: Healthy males and females.
• Women of child bearing potential (WOCBP) with negative serum pregnancy test
• Women must not be breastfeeding
• Men and WOCBP must agree to follow instructions for contraception

You may not qualify if:

• History of any chronic or acute illness, gastrointestinal disease, GI surgery, cardiac disease or clinically significant cardiac arrhythmia
• History of frequent headaches or acute diarrhoea.
• Any major surgery within 4 weeks of study drug administration
• Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
• History of allergy to HIV maturation and integrase inhibitors,or related compounds
• History of smoking

Sponsors & Collaborators

• ViiV Healthcare: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

GSK Investigational Site

Austin, Texas, 78744, United States

Location

Related Links

• Description BMS Clinical Trial Education Resource
• Description Investigator Inquiry Form
• Description FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Infections; Acquired Immunodeficiency Syndrome

Interventions

dolutegravir; BMS-955176

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• GSK Clinical Trials

  ViiV Healthcare

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 22, 2016
• Study Start: April 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: January 19, 2017

Record last verified: 2017-01

Locations

US (1)