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Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (n=16) buprenorphine/naloxone + BEM/RZR | Experimental |
| |
| (n=16) methadone + BEM/RZR | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine/Naloxone + BEM/RZR | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone | Cmax | Day -5 to Day 13 |
| Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone | AUC | Day -5 to Day 13 |
| Effect of BEM/RZR on PK of methadone | Cmax | Day -5 to Day 13 |
| Effect of BEM/RZR on PK of methadone | AUC | Day -5 to Day 13 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Atea Study Clinical Trials Administrator | Contact | 888-481-1607 | ateaclinicaltrials@ateapharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atea Study Site | Recruiting | Hollywood | Florida | 33019 | United States |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D009270 | Naloxone |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Methadone +BEM/RZR | Drug | 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 | Recruiting | Overland Park | Kansas | 66212 | United States |
|
| Atea Study Site | Recruiting | Marlton | New Jersey | 08053 | United States |
|
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |