Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Day -5 to Day -1:buprenorphine/naloxone as individualized QD doses up to 24mg/6mg. Day 1 to Day 5:Individualized QD doses of buprenorphine/naloxone. Day 6 to Day 12:Individualized QD doses of buprenorphine/naloxone + BEM 550mg/RZR 180mg QD. Day 13 Individualized QD doses of buprenorphine/naloxone.
Day -5 to Day -1:methadone individualized QD doses: 30-150mg. Day 1 to Day 5:Individualized QD does of methadone. Day 6 to Day 12:Individualized QD doses of methadone + BEM 550mg/RZR 180mg QD. Day 13 Individualized QD doses of methadone.
Atea Study Site
Hollywood, Florida, United States
RECRUITINGAtea Study Site
Overland Park, Kansas, United States
RECRUITINGAtea Study Site
Marlton, New Jersey, United States
RECRUITINGEffect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone
Cmax
Time frame: Day -5 to Day 13
Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone
AUC
Time frame: Day -5 to Day 13
Effect of BEM/RZR on PK of methadone
Cmax
Time frame: Day -5 to Day 13
Effect of BEM/RZR on PK of methadone
AUC
Time frame: Day -5 to Day 13
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