VX-950-TiDP24-C124: A Phase I Trial to Investigate the Potential Pharmacokinetic Interactions Between Telaprevir and Darunavir/Ritonavir and Between Telaprevir and Fosamprenavir/Ritonavir at Steady-state.
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| ClinicalTrials.gov Identifier: NCT00775125 |
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Recruitment Status
:
Completed
First Posted
: October 17, 2008
Last Update Posted
: December 17, 2010
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Sponsor:
Tibotec BVBA
Information provided by:
Tibotec BVBA
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Brief Summary:
The primary objectives are to determine the effect of steady-state DRV/rtv 600/100 mg twice daily (b.i.d.) on the steady-state pharmacokinetics of telaprevir 750 mg every (q) 8h and 1125 mg q12h and vice versa;- to determine the effect at steady-state of fAPV/rtv 700/100 mg b.i.d. on the steady-state pharmacokinetics of telaprevir 750 mg q8h and 1125 mg q 12h and vice versa; to determine the steady-state pharmacokinetics of telaprevir 750 mg q8h versus telaprevir 1125 mg q12h, alone and during coadministration of either steady-state DRV/rtv 600/100 mg b.i.d or fAPV/rtv 700/100 mg b.i.d.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis C Telaprevir HIV | Drug: Telaprevir; Darunavir; Ritonavir; Fosamprenavir | Phase 1 |
This is a Phase I, open-label, randomized (patients are assigned different treatments based on chance), 2-way crossover trial in 2 panels of healthy subjects to investigate the effect of steady-state darunavir/ritonavir (DRV/rtv) 600/100 mg b.i.d. (twice a day) or fosamprenavir/ritonavir (fAPV/rtv) 700/100 mg b.i.d. on the steady state pharmacokinetics (study of the bodily absorption, distribution, metabolism, and excretion of drugs) of telaprevir 750 mg q 8h and 1125 mg q12h, and vice versa.Telaprevir is being investigated for the treatment of HCV infection.The trial will enroll 40 subjects, divided over 2 panels of 20 subjects each. Subjects in Panel 1 will receive Treatments A and B, and subjects in Panel 2 will receive Treatments C and D, in a randomized order. In both panels, treatments will be separated by a washout period of at least 13 days. In Panel 1, Treatment A, subjects will receive telaprevir 750 mg q8h on Days 1 to 10, and telaprevir 1125 mg q12h on Days 11 to 13 with a morning dose on Day 14. In Panel 1, Treatment B, subjects will receive DRV/rtv 600/100 mg b.i.d. on Days 1 to 23, with an additional morning dose on Day 24, with coadministration of telaprevir 750 mg q8h on Days 11 to 20, and 1125 mg q12h on Days 21 to 23 with a morning dose on Day 24. In Panel 2, Treatment C, subjects will receive telaprevir 750 mg q 8h on Days 1 to 10, and telaprevir 1125 mg q12h on Days 11 to 13 with a morning dose on Day 14. In Panel 2, Treatment D, subjects will receive fAPV/rtv 700/100 mg b.i.d. on Days 1 to 23, with an additional morning dose on Day 24, with coadministration of telaprevir 750 mg q8h on Days 11 to 20, and 1125 mg q12h on Days 21 to 23 with a morning dose on Day 24. All intakes of study medication will be under fed conditions. Pharmacokinetic profiles of telaprevir and VRT-127394 (Rdiastereomer of telaprevir) will be measured up to 8 hours after intake of the morning dose on Day 10 of Treatments A and C and on Day 20 of Treatments B and D, and up to 12 hours after intake of the morning dose of Day 14 of Treatments A and C and on Day 24 of Treatments B and D. During Treatment B, pharmacokinetic profiles of DRV and ritonavir will be measured up to 12 hours after intake of the morning dose on Day 10, Day 20 and Day 24. During Treatment D, pharmacokinetic profiles of amprenavir and ritonavir will be measured up to 12 hours after intake of the morning dose on Day 10, Day 20 and Day 24. Safety and tolerability evaluations will be recorded at regular intervals throughout the trial period. Group A/C: telaprevir 750 mg each 8 hrs on Days 1-10, and telaprevir 1125 mg each 12hrs on Days 11-13 with a morning dose on Day 14. Group B: DRV/rtv 600/100 mg 2/day on Days 1-23 + morning dose on Day 24 + telaprevir 750 mg each 8 hrs on Days 11-20, and 1125 mg each 12hrs on Days 21 to 23 + morning dose on Day 24. Group D: fAPV/rtv 700/100 mg 2/day on Days 1-23 + morning dose on Day 24, + telaprevir 750 mg each 8hrs Days 11-20, and 1125 mg each 12hrs on Days 21-23 + morning dose on Day 24.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase I, Open-label, Randomized, 2-way Crossover Trial in 40 Healthy Subjects to Investigate the Potential Pharmacokinetic Interactions Between Telaprevir and Darunavir/Ritonavir and Between Telaprevir and Fosamprenavir/Ritonavir at Steady-state. |
| Study Start Date : | June 2008 |
| Actual Primary Completion Date : | October 2008 |
| Actual Study Completion Date : | October 2008 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Ritonavir
Darunavir
Fosamprenavir
Fosamprenavir sodium
Fosamprenavir calcium
Darunavir ethanolate
U.S. FDA Resources
Primary Outcome Measures
:
- Effect of steady-state DRV/rtv 600/100 mg b.i.d. and steady-state of fAPV/rtv 700/100 mg on the steady-state PK of telaprevir 750 mg q8h and 1125 mg q12h and vice versa. Steady-state PK on telaprevir 750 mg q8h and 1125 mg q12h alone.
Secondary Outcome Measures
:
- The secondary objective is to determine the short-term safety and tolerability of coadministration of telaprevir and DRV/rtv, and telaprevir and fAPV/rtv.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Females in menopause for at least 3 years or surgically sterilized
- Nonsmoking or smoking no more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 3 months prior to screening
- Normal weight at screening as defined by a body mass index (BMI) of 18 to 30 kg/m2, extremes included
- Able to comply with protocol requirements
- Healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination, medical history, ECG, vital signs, and the results of blood biochemistry, blood coagulation and hematology tests and a urinalysis carried out at screening.
Exclusion Criteria:
- Subjects must not have a history of any illness that, in the opinion of the investigator or the subject's general practitioner, might confound the results of the study or pose an additional risk in administering trial drug(s) to the subject
- Subjects should currently not use prescription medication. Subjects should stop any short-duration courses of prescription medication at least 14 days before the screening visit. Potential subjects should not stop any chronic, prescribed medication being taken at the direction of a physician, without obtaining agreement from that physician
- Subjects should not have regular treatment with over-the-counter medications. Subjects should stop over-the-counter medications on the date of the screening visit but no less than 7 days prior to the first administration of study medication (Day 1 of Session I). Potential subjects should not stop any chronic, over-the-counter medication being taken at the direction of a physician, without obtaining agreement from that physician
- Subjects should not consumeherbal medications or dietary supplements and grapefruit or grapefruit juice, apple juice, or orange juice within 14 days before the first administration of study medication (Day 1 of Session I)
- Subjects should not have a history of drug or alcohol abuse or addiction within 2 years prior to dosing, or who test positive for alcohol or drugs such as amphetamine, barbiturates, benzodiazepines, cocaine, cannabinoids, opioids, metamphetamine and methadone during the screening period
- Subject should not have participated in a clinical study involving administration of an investigational drug within 3 months or 5 half lives (whichever is longer) prior to the screening visit.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00775125
Sponsors and Collaborators
Tibotec BVBA
Investigators
| Study Director: | Tibotec-Virco Virology BVBA Clinical Trial | Tibotec BVBA |
| ClinicalTrials.gov Identifier: | NCT00775125 History of Changes |
| Other Study ID Numbers: |
CR015208 |
| First Posted: | October 17, 2008 Key Record Dates |
| Last Update Posted: | December 17, 2010 |
| Last Verified: | December 2010 |
Keywords provided by Tibotec BVBA:
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VX-950-TiDP24-C124 VX-950-C124 HCV DDI telaprevir darunavir |
ritonavir fosamprenavir interaction pharmacokinetics steady-state |
Additional relevant MeSH terms:
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Hepatitis C Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Hepatitis Liver Diseases Digestive System Diseases Ritonavir Darunavir Fosamprenavir |
HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |