Cystic FibrosisPhase 1NCT01060566
Study of VX-770 on Midazolam and Rosiglitazone and the Effect of Fluconazole on VX-770
A Phase 1 study testing VX-770 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 VX-770 on Midazolam and Rosiglitazone, and the effect of Fluconazole on VX-770. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- VX-770
- 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
- Feb 2010to Apr 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
- Subjects must be male or female and between 18 and 55 years of age.
- Subjects must be judged to be in good health.
- Subjects must have a body mass index (BMI) from 18 to 30 kg/m2.
Who cannot join
- 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 study drug(s) to the subject.
- Subjects who have human immunodeficiency virus (HIV), hepatitis C, or active hepatitis B.
- Female subjects and female partner(s) of male subjects who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug.
- History of cardiovascular disease, hypoglycemia, or edema.
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 VX-770 on Midazolam and Rosiglitazone and the Effect of Fluconazole on VX-770 in Healthy Subjects
The objectives of this study are to evaluate the effects of VX-770 on Midazolam and Rosiglitazone, and the effect of Fluconazole on VX-770.
- Conditions
- Cystic Fibrosis
- Being tested
- VX-770
- 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 midazolam (2 mg) and on Day 1 and Day 8. Subjects will receive single oral dose of rosiglitazone 4 mg and on Day2 and Day 9. Subjects will receive multiple doses of VX-770 150 mg q12h Day 3-10.
VX-770Drug
In period 2, subjects will receive 150 mg VX-770 q12h orally from Day 1 through the morning of Day 8. On the morning of Period 2 Day 1, subjects will receive a 400 mg loading dose of fluconazole. Thereafter, subjects will receive 200 mg fluconazole qd orally from Day 2 through Day 9.
| Study group | Role | What they receive |
|---|---|---|
| VX-770 | Experimental | Not described Receives: Drug: VX-770 |
| Midazolam | Experimental | Not described Receives: Drug: VX-770 |
| Rosiglitazone | Experimental | Not described Receives: Drug: VX-770 |
| Fluconazole | Experimental | Not described Receives: Drug: VX-770 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Midazolam, Rosiglitazone and VX 770 pharmacokinetic (PK) parameter
Measured: 11 days
Fluconazole and VX 770 PK parameters
Measured: 10 days
Secondary outcomes (3)
1´ hydroxy midazolam PK parameters in plasma
Measured: 11 days
Safety as measured by adverse events, physical examinations, vital signs, ECGs, and clinically significant laboratory assessments
Measured: 21 days
Metabolites PK parameters in plasma
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionMar 2010
- Study completionApr 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
- NCT01060566
- Sponsor's protocol ID
- VX09-770-010
- Status last verified
- Apr 2010
- First submitted
- 29 Jan 2010
- Last updated
- 16 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 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 VX-770 on Midazolam and Rosiglitazone and the Effect of Fluconazole on VX-770 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01060566
- Acronym / sponsor ID
- VX09-770-010
- 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
- Feb 2010
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 2 Feb 2010 (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 VX-770 on Midazolam and Rosiglitazone, and the effect of Fluconazole on VX-770.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VX-770 | Experimental | Drug: VX-770 |
| Midazolam | Experimental | Drug: VX-770 |
| Rosiglitazone | Experimental | Drug: VX-770 |
| Fluconazole | Experimental | Drug: VX-770 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Subjects must be male or female and between 18 and 55 years of age.
- Subjects must be judged to be in good health.
- Subjects must have a body mass index (BMI) from 18 to 30 kg/m2.
Key exclusion criteria (4 listed)
- 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 study drug(s) to the subject.
- Subjects who have human immunodeficiency virus (HIV), hepatitis C, or active hepatitis B.
- Female subjects and female partner(s) of male subjects who are pregnant, nursing, or planning to become pregnant during the study or within 90 days of the last dose of study drug.
- History of cardiovascular disease, hypoglycemia, or edema.
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 midazolam (2 mg) and on Day 1 and Day 8. Subjects will receive single oral dose of rosiglitazone 4 mg and on Day2 and Day 9. Subjects will receive multiple doses of VX-770 150 mg q12h Day 3-10. | Drug | Midazolam, Rosiglitazone, VX-770 |
| VX-770In period 2, subjects will receive 150 mg VX-770 q12h orally from Day 1 through the morning of Day 8. On the morning of Period 2 Day 1, subjects will receive a 400 mg loading dose of fluconazole. Thereafter, subjects will receive 200 mg fluconazole qd orally from Day 2 through Day 9. | Drug | Fluconazole, VX-770 |
Primary outcome
Midazolam, Rosiglitazone and VX 770 pharmacokinetic (PK) parameter
Time frame: 11 days
Fluconazole and VX 770 PK parameters
Time frame: 10 days
3 secondary outcomes
1´ hydroxy midazolam PK parameters in plasma
Time frame: 11 days
Safety as measured by adverse events, physical examinations, vital signs, ECGs, and clinically significant laboratory assessments
Time frame: 21 days
Metabolites PK parameters in plasma
Time frame: 21 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 16 Apr 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 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 3 inclusion and 4 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 16 Apr 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?
Midazolam, Rosiglitazone and VX 770 pharmacokinetic (PK) parameter (time frame: 11 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 16 Apr 2010.