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

• Sponsor: ViiV Healthcare (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02715479
• Collaborator: GlaxoSmithKline (Industry)
• Enrollment: 14
• Location: 1
• Arms: 3
• Duration (Days): 30
• Patients Per Site Per Month: 14.2

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Apr 1, 2016
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Maximum observed plasma concentration (Cmax) for DTG [Days 1 to 5 and days 15 to 21]

2. Area under the concentration-time curve in 1 dosing interval AUC (tau) for DTG [Days 1 to 5 and days 15 to 21]

3. Maximum observed plasma concentration (Cmax) for BMS-955176 [Days 8-21]

4. Area under the concentration-time curve in 1 dosing interval AUC (tau) for BMS-955176 [Days 8-21]

Secondary Outcome Measures

1. Adverse events (AEs) [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.

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Austin	Texas	United States	78744

Sponsors and Collaborators

• ViiV Healthcare
• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, ViiV Healthcare

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: ViiV Healthcare
• ClinicalTrials.gov Identifier: NCT02715479
• Other Study ID Numbers: 206222; AI468-052
• First Posted: Mar 22, 2016
• Last Update Posted: Jan 19, 2017
• Last Verified: Jan 1, 2017

• Additional relevant MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Dolutegravir; BMS-955176

Study Results

No Results Posted as of Jan 19, 2017