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| ID | Type | Description | Link |
|---|---|---|---|
| VX-950-TiDP24-C135 | Other Identifier | Tibotec-Virco Virology BVBA |
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| Name | Class |
|---|---|
| Vertex Pharmaceuticals Incorporated | INDUSTRY |
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The purpose of this study is to evaluate the effect of steady-state (constant concentration of medication in the blood) telaprevir 750 mg every 8 hours on the steady-state pharmacokinetics (how the drug concentrations change over time) of R- and S-methadone.
This is a Phase 1, open-label (all people know the identity of the intervention), single-sequence study to evaluate the potential interaction of steady-state telaprevir on the steady-state pharmacokinetics of methadone. The study consists of 3 phases: the screening phase (within 21 days prior to the start of supervised methadone intake on Day -14), treatment phase, and follow-up phase. Participants on stable methadone maintenance therapy will be enrolled in this study and their methadone doses will not be changed starting at Day -14. During the treatment phase, telaprevir will be added for 7 days (from Day 1 to Day 7) to participants' current methadone therapy. The methadone dosage will not to be changed from Day -14 until Day 7. All the intakes of methadone and telaprevir will be supervised and pharmacokinetic parameters will be measured during the study. Safety evaluations for adverse events, clinical laboratory tests, alcohol breath test, cardiovascular safety, and other evaluations (physical examination, and pharmacodynamic assessments) will be performed throughout the study. The total duration of the study for each participant is approximately 60 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telaprevir + Methadone | Experimental | Patients will receive telaprevir 750 mg orally, every 8 hours from Day 1 to Day 7, along with methadone 30 to 130 mg, once daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telaprevir | Drug | Telaprevir 750 mg will be administered orally, every 8 hours from Day 1 to Day 7, along with methadone, once daily. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of telaprevir | Pharmacokinetic parameter Cmax of telaprevir is measured when telaprevir will be administered at 750 mg every 8 hours for 7 days added to stable methadone maintenance therapy. | On Day 7 |
| Minimum plasma concentration (Cmin) of telaprevir | Pharmacokinetic parameter Cmin of telaprevir is measured when telaprevir will be administered every 8 hours for 7 days added to stable methadone maintenance therapy. | On Day 7 |
| Area under the plasma concentration-time curve (AUC) of telaprevir | Pharmacokinetic parameter AUC of telaprevir is measured when telaprevir will be administered every 8 hours for 7 days added to stable methadone maintenance therapy. | On Day 7 |
| Cmax of R-methadone | Pharmacokinetic parameter Cmax of R-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir at 750 mg every 8 hours. | Day -1 and Day 7 |
| Cmin of R-methadone | Pharmacokinetic parameter Cmin of R-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir every 8 hours. | Day -1 and Day 7 |
| AUC of R-methadone | Pharmacokinetic parameter AUC of R-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir every 8 hours. | Day -1 and Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Short Opiate Withdrawal Scale [SOWS] | Pharmacodynamic assessments of methadone withdrawal are performed by means of SOWS. | Day -7, and Day -2 to Day 7 |
| Desires for Drugs Questionnaire [DDQ] | Pharmacodynamic assessments of methadone withdrawal are performed by means of DDQ. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tibotec-Virco Virology BVBA Clinical Trial | Tibotec BVBA | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23478952 | Derived | van Heeswijk R, Verboven P, Vandevoorde A, Vinck P, Snoeys J, Boogaerts G, De Paepe E, Van Solingen-Ristea R, Witek J, Garg V. Pharmacokinetic interaction between telaprevir and methadone. Antimicrob Agents Chemother. 2013 May;57(5):2304-9. doi: 10.1128/AAC.02262-12. Epub 2013 Mar 11. |
| Label | URL |
|---|---|
| A Phase I, open-label, single-sequence drug-drug interaction trial in subjects on stable methadone maintenance therapy, to investigate the potential interaction between telaprevir 750 mg q8h and methadone, at steady-state. | View source |
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| ID | Term |
|---|---|
| C486464 | telaprevir |
| D008691 | Methadone |
| ID | Term |
|---|---|
| D007659 | Ketones |
| D009930 | Organic Chemicals |
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| Methadone | Drug | Methadone 30 to 130 mg will be administered as a stable oral therapy from Day -14 to Day -1, in combination with telaprevir from Day 1 to Day 7, and then alone as a continued intake dose for an additional 30 to 32 days. |
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| Cmax of S-methadone |
Pharmacokinetic parameter Cmax of S-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir at 750 mg every 8 hours. |
| Day -1 and Day 7 |
| Cmin of S-methadone | Pharmacokinetic parameter Cmin of S-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir every 8 hours. | Day -1 and Day 7 |
| AUC of S-methadone | Pharmacokinetic parameter AUC of S-methadone is measured during stable methadone maintenance therapy alone and in the presence of steady-state telaprevir every 8 hours. | Day -1 and Day 7 |
| Day -7, and Day -2 to Day 7 |
| Pupillometry | Pharmacodynamic assessments of methadone withdrawal are performed by means of pupillometry. | Day -1, Day 2, Day 4, and Day 7 |
| Number of participants with adverse events | Up to 60 days |