Chronic Hepatitis CPhase 1NCT01511432
A Study to Assess the Relative Bioavailability Three New Formulations of Telaprevir in Healthy Subjects
A Phase 1 study testing telaprevir formulation A, telaprevir Formulation B and telaprevir Formulation C in people with Chronic Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- telaprevir formulation A, telaprevir Formulation B and telaprevir Formulation C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Jul 2012
- 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
- Healthy subjects (male and female of non-childbearing potential) between the ages of 18 and 55 years
- Non-childbearing potential female subjects
- Male subjects and female partners must agree to use at least 2 methods of contraception
- Subjects with a body mass index (BMI) of 18 to 30 kg/m2 and weigh >50 kg at the Screening Visit.
Who cannot join
- Subjects with a positive test result for hepatitis B, hepatitis C, or HIV
- Subjects with a significant history of any illness, as deemed important by the investigator or any condition possibly affecting drug absorption
- Subjects with a positive urine screen for drugs of abuse
- Subjects with a history of regular alcohol consumption
- Subjects treated with an investigational drug within 30 days
- For Part A only: Subjects with 12-lead ECG QTcF >450 msec (males) or QTcF >470 msec (females) at the Screening Visit
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- Subjects who use prescription and/or nonprescription medications or vitamins and/or dietary supplements
- Subjects who have made a blood donation of approximately 1 pint (500 mL) within 56 days prior to the first dose of study drug
- Subjects who have a female partner who is pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug
- Subjects on hormone replacement therapy (HRT) must discontinue such therapy 28 days prior to the first dose of study drug
- Subjects who have a habit of using tobacco or nicotine containing products within 6 months before the Screening Visit
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas
Dallas, Texas, 75247
Wisconsin
Madison, Wisconsin, 53704
About this study
Official title: A Two-Part, Phase 1, Randomized, Open-Label, Crossover Study to Evaluate the Relative Bioavailability of 3 Novel Oral Formulations of Telaprevir Relative to Incivek 375-mg Tablets When Administered as a Single 1125-mg Dose to Healthy Subjects
The purpose of this study is to evaluate the relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.
- Conditions
- Chronic Hepatitis C
- Being tested
- telaprevir formulation A, telaprevir Formulation B, telaprevir Formulation C, telaprevir Formulation D
- Keywords
- Relative bioavailability, telaprevir formulations
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telaprevir formulation ADrug
A single 1125-mg dose administered orally
telaprevir Formulation BDrug
A single 1125-mg dose administered orally
telaprevir Formulation CDrug
A single 1125-mg dose administered orally
telaprevir Formulation DDrug
A single 1125-mg dose administered orally
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Part A will be a 4-formulation, 4-sequence, 4-period crossover relative bioavailability study of 3 novel oral telaprevir formulations relative to the 375-mg Incivek tablet in the fed state. Receives: Drug: telaprevir formulation A; Drug: telaprevir Formulation B; Drug: telaprevir Formulation C; Drug: telaprevir Formulation D |
| Part B | Experimental | Part B will be a 2-formulation, 6-sequence, 3-period cross-over relative bioavailability study of the novel oral telaprevir formulation selected from Part A in the fasted relative to the fed state and relative to the 375-mg Incivek tablet in the fasted state Receives: Drug: telaprevir formulation A; Drug: telaprevir Formulation B; Drug: telaprevir Formulation C; Drug: telaprevir Formulation D |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve (AUC) from time 0 to infinity (AUC0-∞)
Measured: Up to 57 days
• PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve AUC from time 0 to last time point (AUC0-tlast)
Measured: Up to 57 Days
Secondary outcomes (2)
The safety and tolerability of 3 oral formulations of telaprevir as assessed by adverse events, serious adverse events and results of clinical laboratory tests (serum chemistry, hematology, and urinalysis), vital signs, and 12-lead electrocardiograms
Measured: Up to 57days
Time to reach Cmax after dosing (tmax) and terminal half-life (t1/2) of telaprevir
Measured: Up to 57 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511432
- Sponsor's protocol ID
- VX11-950-025
- Status last verified
- Jul 2012
- First submitted
- 9 Jan 2012
- Last updated
- 4 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part, Phase 1, Randomized, Open-Label, Crossover Study to Evaluate the Relative Bioavailability of 3 Novel Oral Formulations of Telaprevir Relative to Incivek 375-mg Tablets When Administered as a Single 1125-mg Dose to Healthy Subjects
- ClinicalTrials.gov ID
- NCT01511432
- Acronym / sponsor ID
- VX11-950-025
- Conditions
- Chronic Hepatitis C
- Keywords
- Relative bioavailability, telaprevir formulations
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 18 Jan 2012 (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 relative bioavailability, safety, and tolerability of 3 new formulations of telaprevir relative to the Incivek 375-mg tablets.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: telaprevir formulation A, Drug: telaprevir Formulation B, Drug: telaprevir Formulation C, Drug: telaprevir Formulation DPart A will be a 4-formulation, 4-sequence, 4-period crossover relative bioavailability study of 3 novel oral telaprevir formulations relative to the 375-mg Incivek tablet in the fed state. |
| Part B | Experimental | Drug: telaprevir formulation A, Drug: telaprevir Formulation B, Drug: telaprevir Formulation C, Drug: telaprevir Formulation DPart B will be a 2-formulation, 6-sequence, 3-period cross-over relative bioavailability study of the novel oral telaprevir formulation selected from Part A in the fasted relative to the fed state and relative to the 375-mg Incivek tablet in the fasted state |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects (male and female of non-childbearing potential) between the ages of 18 and 55 years
- Non-childbearing potential female subjects
- Male subjects and female partners must agree to use at least 2 methods of contraception
- Subjects with a body mass index (BMI) of 18 to 30 kg/m2 and weigh >50 kg at the Screening Visit.
Key exclusion criteria (11 listed)
- Subjects with a positive test result for hepatitis B, hepatitis C, or HIV
- Subjects with a significant history of any illness, as deemed important by the investigator or any condition possibly affecting drug absorption
- Subjects with a positive urine screen for drugs of abuse
- Subjects with a history of regular alcohol consumption
- Subjects treated with an investigational drug within 30 days
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 formulation AA single 1125-mg dose administered orally | Drug | Part A, Part B |
| telaprevir Formulation BA single 1125-mg dose administered orally | Drug | Part A, Part B |
| telaprevir Formulation CA single 1125-mg dose administered orally | Drug | Part A, Part B |
| telaprevir Formulation DA single 1125-mg dose administered orally | Drug | Part A, Part B |
Primary outcome
PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve (AUC) from time 0 to infinity (AUC0-∞)
Time frame: Up to 57 days
• PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve AUC from time 0 to last time point (AUC0-tlast)
Time frame: Up to 57 Days
2 secondary outcomes
The safety and tolerability of 3 oral formulations of telaprevir as assessed by adverse events, serious adverse events and results of clinical laboratory tests (serum chemistry, hematology, and urinalysis), vital signs, and 12-lead electrocardiograms
Time frame: Up to 57days
Time to reach Cmax after dosing (tmax) and terminal half-life (t1/2) of telaprevir
Time frame: Up to 57 Days
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 4 Jul 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing telaprevir formulation A, telaprevir Formulation B and telaprevir Formulation C in people with Chronic Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 2 sites in United States.
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 4 inclusion and 11 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 4 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
PK parameters: Maximum plasma concentration (Cmax), area under the concentration versus time curve (AUC) from time 0 to infinity (AUC0-∞) (time frame: Up to 57 days). The study lists 2 primary outcomes in all. 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 4 Jul 2012.