Study of VX-770 on Midazolam and Rosiglitazone and the Effect of Fluconazole on VX-770

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01060566
• Other study ID #: VX09-770-010
• Status: Completed
• Phase: Phase 1
• First received: January 29, 2010
• Last updated: April 15, 2010
• Start date: February 2010
• Est. completion date: April 2010

Study information

• Verified date: April 2010
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

Drug:
• VX-770
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-770
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.

Locations

Country	Name	City	State
United States	Covan CRU, Inc.	Daytona Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Midazolam, Rosiglitazone and VX 770 pharmacokinetic (PK) parameter		11 days	No
Primary	Fluconazole and VX 770 PK parameters		10 days	No
Secondary	1´ hydroxy midazolam PK parameters in plasma		11 days	No
Secondary	Safety as measured by adverse events, physical examinations, vital signs, ECGs, and clinically significant laboratory assessments		21 days	Yes
Secondary	Metabolites PK parameters in plasma		21 days	No