Hepatitis CPhase 1NCT00973388
VX-950-TiDP24-C136 - A Trial to Evaluate the Effect of Telaprevir (TVR) on the Results of Electrocardiograms (Electric Recording of the Heart) in Healthy Volunteers
A Phase 1 study of Hepatitis C, run by Tibotec BVBA.
Trial summary
The purpose of this study is to evaluate the effect of telaprevir on the results of electrocardiograms in healthy volunteers. An electrocardiogram is an electric recording of the heart. Telaprevir is being investigated for the treatment of chronic hepatitis C virus infection. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Jan 2010
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Non-smoking for at least 6 months prior to screening
- A body mass index (BMI, weight in kg divided by the square of height in meters) of 18 to30 kg/m2, extremes included
- Otherwise healthy on the basis of a physical examination, medical history, electrocardiogram, vital signs and the results of laboratory tests and a urinalysis carried out at screening
Who cannot join
- Consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week from 14 days before the first intake of study medication and of an average of more than five 240-mL servings of coffee or other caffeinated beverage (e.g. tea, cola) per day from screening onwards
- A history of drug or alcohol abuse or addiction within 2 years prior to dosing, or a positive test for alcohol or drugs during the screening period
- Participation in a clinical study involving administration of an investigational drug within 2 months or 5 half lives (whichever is longer) prior to the screening visit
- Donation of any blood or having had a significant loss of blood within 3 months, or donation of more than 1 unit of plasma within 7 days before the first dose of study drug
- Male patients with female partners who are planning to become pregnant during the study or within 90 days of the last dose of study medication and female patients of childbearing potential who are pregnant or planning to become pregnant within 90 days of the completion of the study, who are not using adequate contraception, or who are breastfeeding
About this study
Official title: A Double-blind, Double-dummy, Randomized, Placebo- and Active-controlled, Four-period Crossover Trial to Evaluate the Effect of Telaprevir (TVR) on the QT/QTc Interval in Healthy Subjects
The purpose of this study is to evaluate the effect of telaprevir on the results of electrocardiograms in healthy volunteers. An electrocardiogram is an electric recording of the heart. Telaprevir is being investigated for the treatment of chronic hepatitis C virus infection.
Read the detailed description
This is a Phase I, double-blind, double-dummy, randomized, placebo- and active-controlled, 4-period crossover trial. This means the study doctor nor yourself know in which treatment session you will receive which active medication or matching placebo. Every participant will receive each treatment in turn. The order in which you receive the treatment sessions is determined by chance, like tossing a coin. The purpose of the study is to evaluate the effect of telaprevir (TVR) on the results of electrocardiograms (electric recording of the heart). Two dose regimens of TVR will be tested, i.e. 750 mg every 8 hours (the dose that will be given to patients) and 1875 mg every 8 hours (a dose higher than the one that will be given to patients), administered for 4 days, with an additional morning dose on Day 5. A single dose of 400 mg moxifloxacin will be used as a positive control to assess trial sensitivity. The trial population will consist of 44 healthy volunteers. Treatment A will consist of TVR 750 mg every 8 hours on Days 1-4 + single 750 mg morning dose on Day 5 (2 active TVR tablets + 3 TVR placebo tablets every 8 hours on Days 1 to 4 with a single morning dose on Day 5, and a single morning dose of moxifloxacin placebo on Day 5). Treatment B will consist of TVR 1875 mg every 8 hours on Days 1 to 4 + single 1875 mg morning dose on Day 5 (5 active TVR tablets every 8 hours on Days 1 to 4 with a single morning dose on Day 5, and a single morning dose of moxifloxacin placebo on Day 5). Treatment C will consist of a single dose of 400 mg moxifloxacin (5 TVR placebo tablets every 8 hours on Days 1 to 4 with a single morning dose on Day 5, and a single morning dose of active moxifloxacin on Day 5). Treatment D will consist of placebo (5 TVR placebo tablets every 8 hours on Days 1 to 4 with a single morning dose on Day 5, and a single morning dose of moxifloxacin placebo on Day 5).There will be a washout period of 8 days between subsequent treatment sessions. Electrocardiograms (ECGs) will be recorded continuously for 24 hours by Holter monitoring (small electrodes will be attached to your chest and connected to a small device to record your heart rhythm over a 24-hour period) on the day before intake of study medication starts and on Day 5 of all treatment sessions. In addition, for safety monitoring, separate ECGs will be performed at predefined time points. Samples to access pharmacokinetics (how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body) of TVR and moxifloxacin will be collected on the day before intake of medication starts and day 5 of all treatment sessions, as well as predose on Days 2, 3 and 4 of all treatment sessions. Safety and tolerability will be evaluated throughout the trial by evaluating results of blood- and urine analysis, vital signs, physical examinations, alcohol breath tests and by assessing how you are feeling. In every treatment session, participants will receive 5 oral tablets of 375 mg TVR or placebo every 8 hours on Days 1 to 4 with a single morning dose on Day 5, and a single oral morning dose of 400 mg moxifloxacin or placebo on Day 5. In between treatment sessions, there will be a wash-out period of 8 days.
- Conditions
- Hepatitis C
- Being tested
- Telaprevir; Moxifloxacin; Placebo
- Keywords
- VX-950-TiDP24-C136, VX-950-C136, VX-950, HEPATITIS, Telaprevir, Moxifloxacin, ECG, QT, QTc
- Medical subject headings
- Hepatitis C, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telaprevir; Moxifloxacin; PlaceboDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to evaluate the effect of administration of TVR 750 mg every 8 hours and 1875 mg every 8 hours, both at steady-state, versus placebo on the QT and QTc interval (heart activity) in healthy volunteers.
Measured: For each dosing period, QT/QTc data will be recorded continuously for 24 hours by 12-lead Holter monitoring on Day-1 and Day 5. Time-matched triplicate ECGs at predose, and at 1, 2, 3, 4, 5, 6, 8 and 24 hour time points will be extracted.
Secondary outcomes (5)
Trial sensitivity will be evaluated (i.e., the effect of a positive control, a single 400 mg dose of moxifloxacin, on the QT/QTc interval).
Measured: In treatment session C, QT/QTc data will be recorded continuously for 24 hours by 12-lead Holter monitoring on Day-1 and Day 5. Time-matched triplicate ECGs at predose, and at 1, 2, 3, 4, 5, 6, 8 and 24 hour time points will be extracted.
The effect of 2 different regimens of TVR on non-QT interval electrocardiogram (ECG) parameters (RR interval, HR, PR interval, and QRS interval) will be evaluated.
Measured: In treatment session A and B, QT/QTc data will be recorded continuously for 24 hours by 12-lead Holter monitoring on Day-1 and Day 5. Time-matched triplicate ECGs at predose, and at 1, 2, 3, 4, 5, 6, 8 and 24 hour time points will be extracted.
The pharmacokinetics of 2 dose regimens of TVR, 750 mg every 8 hours and 1875 mg every 8 hours, at steady-state will be evaluated.
Measured: Samples to access pharmacokinetics of TVR will be collected on Days -1 and 5 of each treatment session (8 times sampling in a period of 9 hours), as well as predose on Days 2, 3 and 4 of each treatment session.
The concentration-effect relationship for QT/QTc for TVR will be explored.
Measured: In each treatment session, QT/QTc data will be recorded continuously for 24 hours by 12-lead Holter monitoring on Day-1 and Day 5. Time-matched triplicate ECGs at predose, and at 1, 2, 3, 4, 5, 6, 8 and 24 hour time points will be extracted.
The short-term safety and tolerability of 2 dose regimens of TVR, 750 mg and 1875 mg every 8 hours will be evaluated.
Measured: Safety will be assessed from screening until the last trial related visit (approximately 15 weeks). Tolerability will be evaluated from the first dosing in the first treatment session until the last trial related visit (approximately 12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2010
- Study completionJan 2010
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
- Double blind
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tibotec BVBA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vertex Pharmaceuticals Incorporated
- Investigators
- Tibotec-Virco Virology BVBA Clinical Trial, Study director, Tibotec BVBA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973388
- Sponsor's protocol ID
- CR016417
- Status last verified
- Dec 2010
- First submitted
- 4 Sep 2009
- 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 Double-blind, Double-dummy, Randomized, Placebo- and Active-controlled, Four-period Crossover Trial to Evaluate the Effect of Telaprevir (TVR) on the QT/QTc Interval in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00973388
- Acronym / sponsor ID
- CR016417
- Conditions
- Hepatitis C
- Keywords
- VX-950-TiDP24-C136, VX-950-C136, VX-950, HEPATITIS, Telaprevir, Moxifloxacin, ECG, QT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Tibotec BVBAIndustry (pharma, biotech, devices)
- Collaborators
- Vertex Pharmaceuticals Incorporated
- Study start
- Oct 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 9 Sep 2009 (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 purpose of this study is to evaluate the effect of telaprevir on the results of electrocardiograms in healthy volunteers. An electrocardiogram is an electric recording of the heart. Telaprevir is being investigated for the treatment of chronic hepatitis C virus infection.
Detailed description
This is a Phase I, double-blind, double-dummy, randomized, placebo- and active-controlled, 4-period crossover trial. This means the study doctor nor yourself know in which treatment session you will receive which active medication or matching placebo. Every participant will receive each treatment in turn. The order in which you receive the treatment sessions is determined by chance, like tossing a coin. The purpose of the study is to evaluate the effect of telaprevir (TVR) on the results of electrocardiograms (electric recording of the heart). Two dose regimens of TVR will be tested, i.e. 750 mg every 8 hours (the dose that will be given to patients) and 1875 mg every 8 hours (a dose higher than the one that will be given to patients), administered for 4 days, with an additional morning dose on Day 5. A single dose of 400 mg moxifloxacin will be used as a positive control to assess trial sensitivity. The trial population will consist of 44 healthy volunteers. Treatment A will consist of TVR 750 mg every 8 hours on Days 1-4 + single 750 mg morning dose on Day 5 (2 active TVR tablets + 3 TVR placebo tablets every 8 hours on Days 1 to 4 with a single morning dose on Day 5, and a single morning dose of moxifloxacin placebo on Day 5). Treatment B will consist of TVR 1875 mg every 8 hours on Days 1 to 4 + single 1875 mg morning dose on Day 5 (5 active TVR tablets every 8 hours on Days 1 to 4 with a single morning dose on Day 5, and a single morning dose of moxifloxacin placebo on Day 5). Treatment C will consist of a single dose of 400 mg moxifloxacin (5 TVR placebo tablets every 8 hours on Days 1 to 4 with a single morning dose on Day 5, and a single morning dose of active moxifloxacin on Day 5). Treatment D will consist of placebo (5 TVR placebo tablets every 8 hours on Days 1 to 4 with a single morning dose on Day 5, and a single morning dose of moxifloxacin placebo on Day 5).There will be a washout period of 8 days between subsequent treatment sessions. Electrocardiograms (ECGs) will be recorded continuously for 24 hours by Holter monitoring (small electrodes will be attached to your chest and connected to a small device to record your heart rhythm over a 24-hour period) on the day before intake of study medication starts and on Day 5 of all treatment sessions. In addition, for safety monitoring, separate ECGs will be performed at predefined time points. Samples to access pharmacokinetics (how the drug is absorbed into the bloodstream, distributed in the body and eliminated from the body) of TVR and moxifloxacin will be collected on the day before intake of medication starts and day 5 of all treatment sessions, as well as predose on Days 2, 3 and 4 of all treatment sessions. Safety and tolerability will be evaluated throughout the trial by evaluating results of blood- and urine analysis, vital signs, physical examinations, alcohol breath tests and by assessing how you are feeling. In every treatment session, participants will receive 5 oral tablets of 375 mg TVR or placebo every 8 hours on Days 1 to 4 with a single morning dose on Day 5, and a single oral morning dose of 400 mg moxifloxacin or placebo on Day 5. In between treatment sessions, there will be a wash-out period of 8 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Non-smoking for at least 6 months prior to screening
- A body mass index (BMI, weight in kg divided by the square of height in meters) of 18 to30 kg/m2, extremes included
- Otherwise healthy on the basis of a physical examination, medical history, electrocardiogram, vital signs and the results of laboratory tests and a urinalysis carried out at screening
Key exclusion criteria (5 listed)
- Consumption of more than 2 units of alcoholic beverages per day or more than 14 units per week from 14 days before the first intake of study medication and of an average of more than five 240-mL servings of coffee or other caffeinated beverage (e.g. tea, cola) per day from screening onwards
- A history of drug or alcohol abuse or addiction within 2 years prior to dosing, or a positive test for alcohol or drugs during the screening period
- Participation in a clinical study involving administration of an investigational drug within 2 months or 5 half lives (whichever is longer) prior to the screening visit
- Donation of any blood or having had a significant loss of blood within 3 months, or donation of more than 1 unit of plasma within 7 days before the first dose of study drug
- Male patients with female partners who are planning to become pregnant during the study or within 90 days of the last dose of study medication and female patients of childbearing potential who are pregnant or planning to become pregnant within 90 days of the completion of the study, who are not using adequate contraception, or who are breastfeeding
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; Moxifloxacin; Placebo | Drug | – |
Primary outcome
The primary objective is to evaluate the effect of administration of TVR 750 mg every 8 hours and 1875 mg every 8 hours, both at steady-state, versus placebo on the QT and QTc interval (heart activity) in healthy volunteers.
Time frame: For each dosing period, QT/QTc data will be recorded continuously for 24 hours by 12-lead Holter monitoring on Day-1 and Day 5. Time-matched triplicate ECGs at predose, and at 1, 2, 3, 4, 5, 6, 8 and 24 hour time points will be extracted.
5 secondary outcomes
Trial sensitivity will be evaluated (i.e., the effect of a positive control, a single 400 mg dose of moxifloxacin, on the QT/QTc interval).
Time frame: In treatment session C, QT/QTc data will be recorded continuously for 24 hours by 12-lead Holter monitoring on Day-1 and Day 5. Time-matched triplicate ECGs at predose, and at 1, 2, 3, 4, 5, 6, 8 and 24 hour time points will be extracted.
The effect of 2 different regimens of TVR on non-QT interval electrocardiogram (ECG) parameters (RR interval, HR, PR interval, and QRS interval) will be evaluated.
Time frame: In treatment session A and B, QT/QTc data will be recorded continuously for 24 hours by 12-lead Holter monitoring on Day-1 and Day 5. Time-matched triplicate ECGs at predose, and at 1, 2, 3, 4, 5, 6, 8 and 24 hour time points will be extracted.
The pharmacokinetics of 2 dose regimens of TVR, 750 mg every 8 hours and 1875 mg every 8 hours, at steady-state will be evaluated.
Time frame: Samples to access pharmacokinetics of TVR will be collected on Days -1 and 5 of each treatment session (8 times sampling in a period of 9 hours), as well as predose on Days 2, 3 and 4 of each treatment session.
The concentration-effect relationship for QT/QTc for TVR will be explored.
Time frame: In each treatment session, QT/QTc data will be recorded continuously for 24 hours by 12-lead Holter monitoring on Day-1 and Day 5. Time-matched triplicate ECGs at predose, and at 1, 2, 3, 4, 5, 6, 8 and 24 hour time points will be extracted.
The short-term safety and tolerability of 2 dose regimens of TVR, 750 mg and 1875 mg every 8 hours will be evaluated.
Time frame: Safety will be assessed from screening until the last trial related visit (approximately 15 weeks). Tolerability will be evaluated from the first dosing in the first treatment session until the last trial related visit (approximately 12 weeks).
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 of Hepatitis C, 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 3 inclusion and 5 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?
The primary objective is to evaluate the effect of administration of TVR 750 mg every 8 hours and 1875 mg every 8 hours, both at steady-state, versus placebo on the QT and QTc interval (heart activity) in healthy volunteers. (time frame: For each dosing period, QT/QTc data will be recorded continuously for 24 hours by 12-lead Holter monitoring on Day-1 and Day 5. Time-matched triplicate ECGs at predose, and at 1, 2, 3, 4, 5, 6, 8 and 24 hour time points will be extracted.). 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.