A Study to Assess the Drug-drug Interaction of BMS 663068 With Methadone and Also With Buprenorphine/Naloxone

Infection, Human Immunodeficiency Virus Clinical Trial

Official title:

A Phase 1, Open-Label, Drug-Drug Interaction Study Between Methadone and BMS-663068; and Between Buprenorphine/Naloxone and BMS-663068

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02666001
• Other study ID #: 206216
• Secondary ID: AI438-068
• Status: Completed
• Phase: Phase 1
• First received: January 6, 2016
• Last updated: August 8, 2017
• Start date: January 12, 2016
• Est. completion date: June 29, 2016

Study information

• Verified date: August 2017
• Source: ViiV Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is being conducted to assess the effect of multiple doses of BMS-663068 on the exposure of methadone in subjects on a stable dose of methadone, and the exposure of buprenorphine and norbuprenorphine in subjects on a stable dose of buprenorphine and norbuprenorphine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 29, 2016
• Est. primary completion date: June 29, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Signed Informed Consent

2. Target population: Subjects on methadone maintenance therapy (for inclusion in Part 1) or buprenorphine and norbuprenorphine maintenance therapy (for inclusion in Part 2), who have been reliably participating in an oral methadone or buprenorphine and norbuprenorphine program and who are on a stable dose for at least 30 days prior to study screening

3. Male and Female Subjects with body mass index of 18 to 34 kg/m2, inclusive

4. Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test and 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, smoking and alcohol abuse

2. Any Gastrointestinal (GI) surgery within 4 weeks of study drug administration that could affect its absorption

3. 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.

4. History of allergy to any drugs, BMS-663068, HIV attachment inhibitors, or related compounds

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Immunologic Deficiency Syndromes
• Infection, Human Immunodeficiency Virus

Intervention

Drug:
• BMS-663068
BMS-663068
• Methadone
Methadone
• Buprenorphine and Norbuprenorphine
Buprenorphine and Norbuprenorphine

Locations

Country	Name	City	State
United States	GSK Investigational Site	Orlando	Florida
United States	GSK Investigational Site	Overland Park	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
ViiV Healthcare	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2)		Days 1 to 10
Primary	AUC(TAU) for Methadone (Part 1) and buprenorphine and norbuprenorphine (Part 2)		Days 1 to 10
Secondary	Incidence of Adverse events (AEs), serious AEs (SAEs), and AEs leading to discontinuation.		For AEs, Days 1 to 10; for SAEs, Screening, Days 1 to 10 and up to 30 days post discontinuation of dosing