A Phase 1 interventional study of Treatment sequence AB and Treatment sequence BA in Hepatitis C, sponsored by Tibotec BVBA. Completed. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-10-16.
Sponsored by Tibotec BVBA (part of Johnson & Johnson) · Phase 1, Interventional, and Treatment
The purpose of this study is to confirm the absence of a clinically relevant interaction between telaprevir and raltegravir at steady-state.Telaprevir is being investigated for the treatment of chronic hepatitis C virus infection, and raltegravir is used to treat HIV infection.
This is an open-label, randomized (the order in which you receive the treatment sessions is determined by chance, like tossing a coin), crossover (participants will receive different interventions sequentially during the trial) study in healthy participants to investigate the effect of telaprevir 750 mg, every 8 hours, on the pharmacokinetics (how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body) of raltegravir 400 mg, twice a day, and vice versa. The study population will consist of 20 healthy participants. Each individual participant will receive two treatments: Treatment A (telaprevir 750 mg, every 8 hours, alone, on Days 1 to 6, with a morning dose on Day 7) and Treatment B (raltegravir 400 mg, twice a day, on Days 1 to 10 and telaprevir 750 mg, every 8 hours, on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11). Half of the participants will receive first Treatment A and then Treatment B; the other half will receive first Treatment B and then Treatment A. There will be a washout period of at least 14 days between the 2 sessions. The screening period will be maximum 21 days; the treatment duration will be approximately 4.5 weeks, and the follow-up period will be 30 to 31 days. All study medication will be taken with food. On Day 7 of Treatment A and Day 11 of Treatment B, 9 blood samples will be taken for determination of the levels of telaprevir in the blood. On Days 4 and 11 of Treatment B, 10 blood samples will be taken for determination of the levels of raltegravir in the blood. Predose pharmacokinetic samples will be collected on other days during the treatment sessions. Safety and tolerability will be evaluated throughout the trial by evaluating results of blood and urine analyses, vital signs, physical examinations, electrocardiograms (electrical recording of the heart), drug and alcohol screenings, and by assessing how the participant is feeling. In Treatment A, participants will receive 2 oral tablets of telaprevir 375 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. In Treatment B, participants will receive 1 oral tablet of 400 mg raltegravir twice a day on Days 1 to 10 and 2 oral tablets of 375 mg telaprevir every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.
2,356 studies on the registry are indexed under Hepatitis C; 101 are open to participants now.
This study's enrollment of 21 is below the median of 79 across 1,660 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →Tibotec BVBA is the lead sponsor of 18 studies on the registry; none are open to participants now.
First submitted after Tibotec BVBA became part of Johnson & Johnson.
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Exclusion Criteria:
Treatment sequence AB Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6 with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10 with a morning dose of raltegravir and a morning and afternoon dose of telaprevir on Day 11.
Drug: Treatment sequence AB
Treatment sequence BA Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6 with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10 with a morning dose of raltegravir and a morning and afternoon dose of telaprevir on Day 11.
Drug: Treatment sequence BA
Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.
Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.
Blood levels of telaprevir and raltegravir when given alone versus when given together
Time frame: Day 7 of Treatment A
Blood levels of telaprevir and raltegravir when given alone versus when given together
Time frame: Day 4 of Treatment B
Blood levels of telaprevir and raltegravir when given alone versus when given together
Time frame: Day 11 of Treatment B
Percentage of participants with a given adverse event as a measure of safety and tolerability
Time frame: From screening to end of study
Clinical laboratory abnormalities as a measure of safety and tolerability
Time frame: At screening and at 5-7 days and 30-32 days after last dose (Treatment A or B)
Clinical laboratory abnormalities as a measure of safety and tolerability
Time frame: On Days 1 and 7 (Treatment A)
Clinical laboratory abnormalities as a measure of safety and tolerability
Time frame: On Days 1, 4, and 11 (Treatment B)
Vital signs observed values and changes from baseline as a measure of safety and tolerability
Time frame: At screening and at 5-7 days and 30-32 days after last dose (Treatment A or B)
Vital signs observed values and changes from baseline as a measure of safety and tolerability
Time frame: On Days 1 and 7 (Treatment A)
Vital signs observed values and changes from baseline as a measure of safety and tolerability
Time frame: On Days 1, 4, and 11 (Treatment B)
Physical examination findings and changes from baseline as a measure of safety and tolerability
Time frame: At screening, on Day -1 of Treatments A and B, and at 5-7 days and 30-32 days after last dose (Treatment A or B)
No study locations are listed for this record.
The record gives a start of Dec 2010 and a completion of Apr 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.
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