Hepatitis CPhase 1NCT00775125
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.
A Phase 1 study testing Telaprevir; Darunavir; Ritonavir; Fosamprenavir in people with Hepatitis C and Telaprevir, run by Tibotec BVBA.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Hepatitis C, Telaprevir, HIV
- What is being tested?
- Telaprevir; Darunavir; Ritonavir; Fosamprenavir
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Oct 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
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.
Read the detailed description
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.
- Conditions
- Hepatitis C, Telaprevir, HIV
- Being tested
- Telaprevir; Darunavir; Ritonavir; Fosamprenavir
- Keywords
- VX-950-TiDP24-C124, VX-950-C124, HCV, DDI, telaprevir, darunavir, ritonavir, fosamprenavir, interaction, pharmacokinetics, steady-state
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telaprevir; Darunavir; Ritonavir; FosamprenavirDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
The secondary objective is to determine the short-term safety and tolerability of coadministration of telaprevir and DRV/rtv, and telaprevir and fAPV/rtv.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2008 (estimated)
- Study startJun 2008
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tibotec BVBA
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Tibotec-Virco Virology BVBA Clinical Trial, Study director, Tibotec BVBA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00775125
- Sponsor's protocol ID
- CR015208
- Status last verified
- Dec 2010
- First submitted
- 16 Oct 2008
- Last updated
- 17 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00775125
- Acronym / sponsor ID
- CR015208
- Conditions
- Hepatitis C, Telaprevir, HIV
- Keywords
- VX-950-TiDP24-C124, VX-950-C124, HCV, DDI, telaprevir, darunavir, ritonavir, fosamprenavir
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tibotec BVBAIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 17 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telaprevir; Darunavir; Ritonavir; Fosamprenavir | Drug | – |
Primary outcome
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.
1 secondary outcome
The secondary objective is to determine the short-term safety and tolerability of coadministration of telaprevir and DRV/rtv, and telaprevir and fAPV/rtv.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tibotec-Virco Virology BVBA Clinical Trial study director
Tibotec BVBA
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Telaprevir; Darunavir; Ritonavir; Fosamprenavir in people with Hepatitis C and Telaprevir, run by Tibotec BVBA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2010.