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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02715479
Recruitment Status : Completed
First Posted : March 22, 2016
Last Update Posted : January 19, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

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

Condition or disease Intervention/treatment Phase
Infection, Human Immunodeficiency Virus Drug: Dolutegravir Drug: BMS955176 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Two-way Drug Interaction Study to Evaluate the Effect of BMS-955176 on the Pharmacokinetics of Dolutegravir and the Effect of Dolutegravir on the Pharmacokinetics of BMS-955176
Study Start Date : April 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Treatment A
Single DTG tablet under fed conditions for a specified period
Drug: Dolutegravir
Dolutegravir

Experimental: Treatment B
Two BMS955176 tablets under fed conditions for a specified period
Drug: BMS955176
BMS955176

Experimental: Treatment C
Single DTG tablet and Two BMS955176 tablets under fed conditions for a specified period
Drug: Dolutegravir
Dolutegravir

Drug: BMS955176
BMS955176




Primary Outcome Measures :
  1. Maximum observed plasma concentration (Cmax) for DTG [ Time Frame: Days 1 to 5 and days 15 to 21 ]
  2. Area under the concentration-time curve in 1 dosing interval AUC (tau) for DTG [ Time Frame: Days 1 to 5 and days 15 to 21 ]
  3. Maximum observed plasma concentration (Cmax) for BMS-955176 [ Time Frame: Days 8-21 ]
  4. Area under the concentration-time curve in 1 dosing interval AUC (tau) for BMS-955176 [ Time Frame: Days 8-21 ]

Secondary Outcome Measures :
  1. Adverse events (AEs) [ Time Frame: Days 1-21; for SAEs up to 30 days post discontinuation of dosing ]
    The incidence of observed AEs will be tabulated and reviewed for potential significance and clinical importance.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. History of any chronic or acute illness, gastrointestinal disease, GI surgery, cardiac disease or clinically significant cardiac arrhythmia
  2. History of frequent headaches or acute diarrhoea.
  3. Any major surgery within 4 weeks of study drug administration
  4. 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
  5. History of allergy to HIV maturation and integrase inhibitors,or related compounds
  6. History of smoking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02715479


Locations
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United States, Texas
GSK Investigational Site
Austin, Texas, United States, 78744
Sponsors and Collaborators
ViiV Healthcare
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials ViiV Healthcare
Additional Information:
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Responsible Party: ViiV Healthcare
ClinicalTrials.gov Identifier: NCT02715479    
Other Study ID Numbers: 206222
AI468-052 ( Other Identifier: Bristol-Myers Squibb )
First Posted: March 22, 2016    Key Record Dates
Last Update Posted: January 19, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Dolutegravir
BMS-955176
HIV Integrase Inhibitors
Integrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents