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The objective of this study is to estimate the effect of lersivirine on the pharmacokinetics of R-methadone and S-methadone and to investigate the safety and tolerability of lersivirine when co-administered with methadone. Symptoms of methadone withdrawal will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methadone | Active Comparator | Dose of methadone must not change from 1 week prior to study start and through the duration of the study. |
|
| Lersivirine + Methadone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methadone | Drug | Methadone 50 - 150 mg QD (Day 1) |
| |
| Lersivirine + Methadone |
| Measure | Description | Time Frame |
|---|---|---|
| R-methadone and S-methadone plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h on Days 1 and 11 | Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments | Day 12 | |
| Symptoms of methadone withdrawal as assessed by the Short Opiate Withdrawal Scale (SOWS), Desires for Drug Questionnaire (DDQ) and Pupillary Diameter measurement performed on Days 0 -12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19139 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Term |
|---|---|
| D008691 | Methadone |
| C531151 | UK 453,061 |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| Drug |
Lersivirine 1000 mg QD + Methadone 50 - 150 mg QD (Days 2-11) |
|
| Day 12 |