Hepatitis CPhase 1NCT00958152
Drug-Drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects
A Phase 1 study testing VCH-222 and telaprevir in people with Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 1 site in New Zealand.
Trial summary
The purpose of this study is to investigate the pharmacokinetics, safety, and tolerability of the co-administration of VCH-222 and telaprevir in healthy subjects. 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
- What is being tested?
- VCH-222 and telaprevir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNew Zealand
- Study dates
- Aug 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
- Healthy males, and/or healthy females of non-childbearing potential, aged 18 to 55 years (inclusive)
- Body mass index (BMI) between 18 and 31 kg/m2 (inclusive) and weight > 50 kg
Who cannot join
- Women of child bearing potential
- Subjects positive for Hepatitis B, Hepatitis C, or HIV
- Subjects who have participated in a clinical study involving administration of an investigational drug within 2 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Sequential-group, Multiple-dose, Drug-drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects
The purpose of this study is to investigate the pharmacokinetics, safety, and tolerability of the co-administration of VCH-222 and telaprevir in healthy subjects.
- Conditions
- Hepatitis C
- Being tested
- VCH-222, telaprevir
- Keywords
- VX-950, VX-222, STAT-C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VCH-222Drug
Capsules, Oral, 400 mg, q12h, Days 1-10 and Days 28-37
VCH-222Drug
Capsules, Oral, 750 mg, q12h, Days 1-10 and Days 28-37
VCH-222Drug
Capsules, Oral, 1000 mg, q12h, Days 1-10 and Days 28-37
telaprevirDrug
Tablet, Oral, 1125 mg, q12h, Days 18-37
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Not described Receives: Drug: VCH-222; Drug: telaprevir |
| Cohort 2 | Experimental | Not described Receives: Drug: VCH-222; Drug: telaprevir |
| Cohort 3 | Experimental | Not described Receives: Drug: VCH-222; Drug: telaprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability based on vital signs, 12-lead electrocardiograms (ECGs), physical examination, laboratory assessments, and adverse events
Measured: Day 47 safety assessment
Secondary outcomes (2)
Pharmacokinetic parameters (Cmax, tmax, C12 h, Cmin, and AUC0-12 h) of VCH-222 at steady-state in plasma in the presence and absence of telaprevir at steady-state
Measured: Day 37 pharmacokinetic assessment
Pharmacokinetics parameters (Cmax, tmax, C12 h, Cmin, and AUC0-12 h) of telaprevir at steady-state in plasma in the presence and absence of VCH-222 at steady-state
Measured: Day 37 pharmacokinetic assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startAug 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.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Vertex Pharmaceuticals Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958152
- Sponsor's protocol ID
- VX09-222-002
- Status last verified
- Jan 2010
- First submitted
- 6 Aug 2009
- Last updated
- 7 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo-controlled, Sequential-group, Multiple-dose, Drug-drug Interaction Study of VCH-222 and Telaprevir in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00958152
- Acronym / sponsor ID
- VX09-222-002
- Conditions
- Hepatitis C
- Keywords
- VX-950, VX-222, STAT-C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 13 Aug 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 investigate the pharmacokinetics, safety, and tolerability of the co-administration of VCH-222 and telaprevir in healthy subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: VCH-222, Drug: telaprevir |
| Cohort 2 | Experimental | Drug: VCH-222, Drug: telaprevir |
| Cohort 3 | Experimental | Drug: VCH-222, Drug: telaprevir |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males, and/or healthy females of non-childbearing potential, aged 18 to 55 years (inclusive)
- Body mass index (BMI) between 18 and 31 kg/m2 (inclusive) and weight > 50 kg
Key exclusion criteria (3 listed)
- Women of child bearing potential
- Subjects positive for Hepatitis B, Hepatitis C, or HIV
- Subjects who have participated in a clinical study involving administration of an investigational drug within 2 months
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 |
|---|---|---|
| VCH-222Capsules, Oral, 400 mg, q12h, Days 1-10 and Days 28-37 | Drug | Cohort 1 |
| VCH-222Capsules, Oral, 750 mg, q12h, Days 1-10 and Days 28-37 | Drug | Cohort 2 |
| VCH-222Capsules, Oral, 1000 mg, q12h, Days 1-10 and Days 28-37 | Drug | Cohort 3 |
| telaprevirTablet, Oral, 1125 mg, q12h, Days 18-37 | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Safety and tolerability based on vital signs, 12-lead electrocardiograms (ECGs), physical examination, laboratory assessments, and adverse events
Time frame: Day 47 safety assessment
2 secondary outcomes
Pharmacokinetic parameters (Cmax, tmax, C12 h, Cmin, and AUC0-12 h) of VCH-222 at steady-state in plasma in the presence and absence of telaprevir at steady-state
Time frame: Day 37 pharmacokinetic assessment
Pharmacokinetics parameters (Cmax, tmax, C12 h, Cmin, and AUC0-12 h) of telaprevir at steady-state in plasma in the presence and absence of VCH-222 at steady-state
Time frame: Day 37 pharmacokinetic assessment
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 7 Jan 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.
Medical Monitor study director
Vertex Pharmaceuticals Incorporated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VCH-222 and telaprevir in people with Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 1 site in New Zealand.
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 2 inclusion and 3 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 7 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. 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?
Safety and tolerability based on vital signs, 12-lead electrocardiograms (ECGs), physical examination, laboratory assessments, and adverse events (time frame: Day 47 safety assessment). 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 7 Jan 2010.