Cystic FibrosisPhase 1NCT01018368
Study of VX-770 and Rifampin in Healthy Male Subjects
A Phase 1 study testing VX-770 and Rifampin in people with Cystic Fibrosis, run by Vertex Pharmaceuticals Incorporated at 1 site in United States.
Trial summary
The objectives of this study are to evaluate the effects of multiple doses of rifampin on the single-dose pharmacokinetics of VX 770. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- VX-770 and Rifampin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Mar 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must be male and between 18 and 55 years of age
- Subject must have a body mass index (BMI) from 18 to 30 kg/m2
Who cannot join
- History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject
- Subjects who have active tuberculosis, human immunodeficiency virus, hepatitis C, or active hepatitis B
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Phase 1 Study to Examine the Effect of Multiple Doses of Rifampin on the Single-Dose Pharmacokinetics of VX 770 in Healthy Subjects
The objectives of this study are to evaluate the effects of multiple doses of rifampin on the single-dose pharmacokinetics of VX 770.
Read the detailed description
This is a single-center, nonrandomized, open-label, 2-period, 1-sequence crossover study to investigate the safety, tolerability and pharmacokinetics of VX 770 when administered alone or with rifampin.
All enrolled subjects will receive the same treatments and undergo the same procedures. In Period 1, subjects will receive a single dose of VX 770 on Day 1. In Period 2, subjects will receive a daily dose of rifampin on Days 1 through 10 and a single dose of VX 770 on Day 6.
- Conditions
- Cystic Fibrosis
- Being tested
- VX-770, Rifampin
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VX-770Drug
In Period 1, subjects will receive a single oral dose of VX-770 150 mg on Day 1. In Period 2, subjects will receive a single oral dose of VX-770 150 mg on Day 6.
RifampinDrug
In Period 2, subjects will receive a daily oral dose of rifampin 600 mg on Days 1 through 10
| Study group | Role | What they receive |
|---|---|---|
| VX-770 | Experimental | Not described Receives: Drug: VX-770 |
| Rifampin | Experimental | Not described Receives: Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
VX 770 pharmacokinetic (PK) parameters
Measured: 17 days
Secondary outcomes (3)
VX 770 metabolite PK parameters in plasma
Measured: 17 days
Rifampin concentration at time zero (C0) and AUC at steady state (AUCtau) following the administration of multiple doses of rifampin
Measured: 17 days
Safety as measured by adverse events, physical examinations, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- H. Frank Farmer, MD, Principal investigator, Covance CRU, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018368
- Sponsor's protocol ID
- VX09-770-009
- Status last verified
- May 2010
- First submitted
- 19 Nov 2009
- Last updated
- 10 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 1 Study to Examine the Effect of Multiple Doses of Rifampin on the Single-Dose Pharmacokinetics of VX 770 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01018368
- Acronym / sponsor ID
- VX09-770-009
- Conditions
- Cystic Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 23 Nov 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 objectives of this study are to evaluate the effects of multiple doses of rifampin on the single-dose pharmacokinetics of VX 770.
Detailed description
This is a single-center, nonrandomized, open-label, 2-period, 1-sequence crossover study to investigate the safety, tolerability and pharmacokinetics of VX 770 when administered alone or with rifampin.
All enrolled subjects will receive the same treatments and undergo the same procedures. In Period 1, subjects will receive a single dose of VX 770 on Day 1. In Period 2, subjects will receive a daily dose of rifampin on Days 1 through 10 and a single dose of VX 770 on Day 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VX-770 | Experimental | Drug: VX-770 |
| Rifampin | Experimental | Drug: Rifampin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Subject must be male and between 18 and 55 years of age
- Subject must have a body mass index (BMI) from 18 to 30 kg/m2
Key exclusion criteria (2 listed)
- History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject
- Subjects who have active tuberculosis, human immunodeficiency virus, hepatitis C, or active hepatitis B
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 |
|---|---|---|
| VX-770In Period 1, subjects will receive a single oral dose of VX-770 150 mg on Day 1. In Period 2, subjects will receive a single oral dose of VX-770 150 mg on Day 6. | Drug | VX-770 |
| RifampinIn Period 2, subjects will receive a daily oral dose of rifampin 600 mg on Days 1 through 10 | Drug | Rifampin |
Primary outcome
VX 770 pharmacokinetic (PK) parameters
Time frame: 17 days
3 secondary outcomes
VX 770 metabolite PK parameters in plasma
Time frame: 17 days
Rifampin concentration at time zero (C0) and AUC at steady state (AUCtau) following the administration of multiple doses of rifampin
Time frame: 17 days
Safety as measured by adverse events, physical examinations, vital signs, electrocardiograms (ECGs), and clinically significant laboratory assessments
Time frame: 17 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 10 May 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.
H. Frank Farmer, MD principal investigator
Covance CRU, Inc.
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 VX-770 and Rifampin in people with Cystic Fibrosis, run by Vertex Pharmaceuticals Incorporated at 1 site 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 2 inclusion and 2 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 10 May 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 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?
VX 770 pharmacokinetic (PK) parameters (time frame: 17 days). 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 10 May 2010.