NCT02045693 is a Phase 1 clinical trial of Methadone in Hepatitis C, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT02045693?

NCT02045693 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT02045693?

Interventions in NCT02045693: Methadone, DCV 3DAA FDC, BMS-791325, Buprenorphine, Naloxone.

What condition does NCT02045693 study?

NCT02045693 studies Hepatitis C.

Is NCT02045693 still recruiting?

NCT02045693 is currently completed. Last updated 16 June 2014.

Last reviewed 2014-06-16 · How we verify

NCT02045693

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase1, Open-Label, Drug-Drug Interaction Study Between Methadone and Daclatasvir/Asunaprevir/BMS-791325 3 DAA FDC + 75mg BMS-791325 and Between Buprenorphine/Naloxone and Daclatasvir/Asunaprevir/BMS-791325 3 DAA FDC +75mg BMS-791325

Completed Phase 1 Last updated 16 June 2014

What this trial tests

Phase 1 trial testing Methadone in Hepatitis C in 32 participants. Completed in 1 April 2014.

Timeline

1 February 2014

Primary endpoint
1 April 2014

1 April 2014

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Enrollment	32
Start date	1 February 2014
Primary completion	1 April 2014
Estimated completion	1 April 2014
Sites	3 locations across United States

Drugs / interventions tested

Methadone (METHADONE) — full drug profile →
DCV 3DAA FDC — full drug profile →
BMS-791325 — full drug profile →
Buprenorphine (BUPRENORPHINE) — full drug profile →
Naloxone (NALOXONE) — full drug profile →

Conditions studied

Hepatitis C — all drugs for Hepatitis C →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

Adults 18 to 65, any sex, with Hepatitis C. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Maximum observed concentration (Cmax) of R-Methadone for Part 1
Time frame: 24 timepoints up to Day 13
Area under the concentration-time curve in one dosing interval (AUC(TAU)) of R-Methadone for Part 1
Time frame: 24 timepoints up to Day 13
Cmax of Buprenorphine and Norbuprenorphine for Part 2
Time frame: 24 timepoints up to Day 13
AUC(TAU) of Buprenorphine and Norbuprenorphine for Part 2
Time frame: 24 timepoints up to Day 13

Sponsor's own description

The purpose of this study is to assess the effects of steady state DCV/ASV/BMS-791325 fixed dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of Methadone in subjects with the stable dose of Methadone and on the PK of Buprenorphine in subjects with the stable dose of Buprenorphine.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Methadone

Trials testing the same drug.

NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
NCT07227064 — Methadone in THA for Post-op Pain and Opioid Reduction · Phase 3 · recruiting
NCT06868589 — Reducing Pain With Methadone and Ketamine in Liver Transplant · Phase 4 · active not recruiting
NCT06810336 — Pain Control and Quality of Recovery After Intravenous Methadone Versus Intravenous Remifentanil in Craniotomy Surgery · EARLY_PHASE1 · not yet recruiting
NCT06576830 — Optimization of Pediatric Tonsillectomy to IMprove AnaLgesia · Phase 4 · recruiting

Other recruiting trials for Hepatitis C

Currently open trials in the same condition.

NCT06263829 — HCV Tappt Adherence Study · NA · recruiting
NCT06179498 — Partner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs · NA · recruiting
NCT06367465 — Feasibility and Acceptability of HCV Treatment in Pregnancy · recruiting
NCT05668780 — Buprenorphine Integration Research and Community Health · NA · active not recruiting
NCT05208697 — Tele-Harm Reduction · NA · active not recruiting

Other Bristol-Myers Squibb trials

Trials by the same sponsor.

NCT07441408 — Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07459543 — A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unre · Phase 4 · not yet recruiting
NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder · Phase 3 · not yet recruiting
NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism · Phase 3 · not yet recruiting
NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02045693 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 16 June 2014

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02045693.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing