Hepatitis CPhase 1NCT02045693
Drug Interaction & Methadone & Buprenorphine
A Phase 1 study testing Methadone, DCV 3DAA FDC and BMS-791325 in people with Hepatitis C, run by Bristol-Myers Squibb at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Methadone, DCV 3DAA FDC and BMS-791325
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2014to Apr 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must be on stable Methadone or Buprenorphine regimens for at least 28 days prior to screening
Who cannot join
- Subjects must be healthy except for history of Methadone or Buprenorphine treatment regimens
- Prior exposure to DCV, ASV or BMS-791325 within 3 months of screening or any other investigational drug or placebo within 4 weeks of study drug administration
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Anaheim Clinical Trials Llc
Anaheim, California, 92801
Cri Lifetree
Philadelphia, Pennsylvania, 19139
Lifetree Clinical Research
Salt Lake City, Utah, 84106
About this study
Official title: 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
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.
Read the detailed description
IND number: 101,943
Primary purpose: Other: Phase 1 Clinical Pharmacology drug interaction study in healthy subjects
- Conditions
- Hepatitis C
- Being tested
- Methadone, DCV 3DAA FDC, BMS-791325, Buprenorphine, Naloxone
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
DCV 3DAA FDCDrug
BMS-791325Drug
BuprenorphineDrug
NaloxoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Methadone + DCV 3DAA FDC + BMS-791325 | Experimental | Methadone 40-120 mg tablet or solution orally once on Day 1
Methadone 40-120 mg tablet or solution orally once daily + DCV 3DAA FDC (Daclatasvir 30 mg/Asunaprevir 200 mg/BMS-791325 75 mg 3 direct-acting antiviral (3DAA) fixed dose combination tablet) orally twice daily + BMS-791325 75 mg tablet orally twice daily on Days 2 through 12 Receives: Drug: Methadone; Drug: DCV 3DAA FDC; Drug: BMS-791325 |
| Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325 | Active comparator | Buprenorphine/Naloxone 8/2 - 24/6 mg tablet or sublingual film orally once on Day 1
Buprenorphine/Naloxone 8/2 - 24/6 mg tablet or sublingual film orally once + DCV 3DAA FDC (Daclatasvir 30 mg/Asunaprevir 200 mg/BMS-791325 75 mg 3DAA fixed dose combination tablet) orally twice daily + BMS-791325 75 mg tablet orally twice daily on Days 2 through 12 Receives: Drug: DCV 3DAA FDC; Drug: BMS-791325; Drug: Buprenorphine; Drug: Naloxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax) of R-Methadone for Part 1
Measured: 24 timepoints up to Day 13
Area under the concentration-time curve in one dosing interval (AUC(TAU)) of R-Methadone for Part 1
Measured: 24 timepoints up to Day 13
Cmax of Buprenorphine and Norbuprenorphine for Part 2
Measured: 24 timepoints up to Day 13
AUC(TAU) of Buprenorphine and Norbuprenorphine for Part 2
Measured: 24 timepoints up to Day 13
Secondary outcomes (15)
Cmax of S-Methadone and Total Methadone for Part 1
Measured: 24 timepoints up to 13 days
AUC(TAU) of S-Methadone and Total Methadone for Part 1
Measured: 24 timepoints up to 13 days
Concentration at 24 hours (C24) of S-Methadone, Total Methadone and R-Methadone for Part 1
Measured: 24 timepoints up to 13 days
Time of maximum observed concentration (Tmax) of S-Methadone, Total Methadone and R-Methadone for Part 1
Measured: 24 timepoints up to 13 days
C24 of Buprenorphine and Norbuprenorphine for Part 2
Measured: 24 timepoints up to 13 days
Tmax of Buprenorphine and Norbuprenorphine for Part 2
Measured: 24 timepoints up to 13 days
Ratio of metabolite AUC(TAU) to parent AUC(TAU) (MR_AUC(TAU)) of Norbuprenorphine to Buprenorphine
Measured: 24 timepoints up to 13 days
Cmax of of Daclatasvir (DCV) , Asunaprevir (ASV) , BMS-791325, and BMS-794712
Measured: 10 timepoints on Day 12
AUC(TAU) of DCV, ASV, BMS-791325, and BMS-794712
Measured: 10 timepoints on Day 12
Concentration at 12 hours (C12) of DCV, ASV, BMS-791325, and BMS-794712
Measured: 10 timepoints on Day 12
Tmax of DCV, ASV, BMS-791325, and BMS-794712
Measured: 10 timepoints on Day 12
MR_AUC(TAU) for BMS-794712 to BMS-791325
Measured: 10 timepoints on Day 12
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), death and AEs leading to discontinuation
Measured: Up to day 13
Results of vital signs, Electrocardiograms (ECGs), Physical Examinations (PEs) and clinical labs
Measured: Up to day 13
Scores of Clinical Opiate Withdrawal Scale (COWS), Subjective Opiate Withdrawal Scale (SOWS), Objective Opiate Withdrawal Scale (OOWS), and Opiate Overdose Assessment (OOA)
Measured: Up to day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02045693
- Sponsor's protocol ID
- AI443-108
- Status last verified
- Jun 2014
- First submitted
- 21 Jan 2014
- Last updated
- 17 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02045693
- Acronym / sponsor ID
- AI443-108
- Conditions
- Hepatitis C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 27 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
IND number: 101,943
Primary purpose: Other: Phase 1 Clinical Pharmacology drug interaction study in healthy subjects
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Methadone + DCV 3DAA FDC + BMS-791325 | Experimental | Drug: Methadone, Drug: DCV 3DAA FDC, Drug: BMS-791325Methadone 40-120 mg tablet or solution orally once on Day 1 Methadone 40-120 mg tablet or solution orally once daily + DCV 3DAA FDC (Daclatasvir 30 mg/Asunaprevir 200 mg/BMS-791325 75 mg 3 direct-acting antiviral (3DAA) fixed dose combination tablet) orally twice daily + BMS-791325 75 mg tablet orally twice daily on Days 2 through 12 |
| Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325 | Active comparator | Drug: DCV 3DAA FDC, Drug: BMS-791325, Drug: Buprenorphine, Drug: NaloxoneBuprenorphine/Naloxone 8/2 - 24/6 mg tablet or sublingual film orally once on Day 1 Buprenorphine/Naloxone 8/2 - 24/6 mg tablet or sublingual film orally once + DCV 3DAA FDC (Daclatasvir 30 mg/Asunaprevir 200 mg/BMS-791325 75 mg 3DAA fixed dose combination tablet) orally twice daily + BMS-791325 75 mg tablet orally twice daily on Days 2 through 12 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject must be on stable Methadone or Buprenorphine regimens for at least 28 days prior to screening
Key exclusion criteria (2 listed)
- Subjects must be healthy except for history of Methadone or Buprenorphine treatment regimens
- Prior exposure to DCV, ASV or BMS-791325 within 3 months of screening or any other investigational drug or placebo within 4 weeks of study drug administration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methadone | Drug | Part 1: Methadone + DCV 3DAA FDC + BMS-791325 |
| DCV 3DAA FDC | Drug | Part 1: Methadone + DCV 3DAA FDC + BMS-791325, Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325 |
| BMS-791325 | Drug | Part 1: Methadone + DCV 3DAA FDC + BMS-791325, Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325 |
| Buprenorphine | Drug | Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325 |
| Naloxone | Drug | Part 2: Buprenorphine/Naloxone + DCV 3DAA FDC + BMS-791325 |
Primary outcome
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
15 secondary outcomes
Cmax of S-Methadone and Total Methadone for Part 1
Time frame: 24 timepoints up to 13 days
AUC(TAU) of S-Methadone and Total Methadone for Part 1
Time frame: 24 timepoints up to 13 days
Concentration at 24 hours (C24) of S-Methadone, Total Methadone and R-Methadone for Part 1
Time frame: 24 timepoints up to 13 days
Time of maximum observed concentration (Tmax) of S-Methadone, Total Methadone and R-Methadone for Part 1
Time frame: 24 timepoints up to 13 days
C24 of Buprenorphine and Norbuprenorphine for Part 2
Time frame: 24 timepoints up to 13 days
Tmax of Buprenorphine and Norbuprenorphine for Part 2
Time frame: 24 timepoints up to 13 days
Ratio of metabolite AUC(TAU) to parent AUC(TAU) (MR_AUC(TAU)) of Norbuprenorphine to Buprenorphine
Time frame: 24 timepoints up to 13 days
Cmax of of Daclatasvir (DCV) , Asunaprevir (ASV) , BMS-791325, and BMS-794712
Time frame: 10 timepoints on Day 12
AUC(TAU) of DCV, ASV, BMS-791325, and BMS-794712
Time frame: 10 timepoints on Day 12
Concentration at 12 hours (C12) of DCV, ASV, BMS-791325, and BMS-794712
Time frame: 10 timepoints on Day 12
Tmax of DCV, ASV, BMS-791325, and BMS-794712
Time frame: 10 timepoints on Day 12
MR_AUC(TAU) for BMS-794712 to BMS-791325
Time frame: 10 timepoints on Day 12
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), death and AEs leading to discontinuation
Time frame: Up to day 13
Results of vital signs, Electrocardiograms (ECGs), Physical Examinations (PEs) and clinical labs
Time frame: Up to day 13
Scores of Clinical Opiate Withdrawal Scale (COWS), Subjective Opiate Withdrawal Scale (SOWS), Objective Opiate Withdrawal Scale (OOWS), and Opiate Overdose Assessment (OOA)
Time frame: Up to day 13
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Methadone, DCV 3DAA FDC and BMS-791325 in people with Hepatitis C, run by Bristol-Myers Squibb at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed concentration (Cmax) of R-Methadone for Part 1 (time frame: 24 timepoints up to Day 13). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2014.