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.
IND number: 101,943 Primary purpose: Other: Phase 1 Clinical Pharmacology drug interaction study in healthy subjects
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
32
Anaheim Clinical Trials Llc
Anaheim, California, United States
Cri Lifetree
Philadelphia, Pennsylvania, United States
Lifetree Clinical Research
Salt Lake City, Utah, United States
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
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
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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