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

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

VX-770

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Covan CRU, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

VX-770

Midazolam

Rosiglitazone

Fluconazole

Arm Description

Outcomes

Primary Outcome Measures

Midazolam, Rosiglitazone and VX 770 pharmacokinetic (PK) parameter

Fluconazole and VX 770 PK parameters

Secondary Outcome Measures

1´ hydroxy midazolam PK parameters in plasma

Safety as measured by adverse events, physical examinations, vital signs, ECGs, and clinically significant laboratory assessments

Metabolites PK parameters in plasma

Full Information

NCT ID

NCT01060566

First Posted

January 29, 2010

Last Updated

April 15, 2010

Sponsor

Vertex Pharmaceuticals Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01060566

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Completed

Study Start Date

February 2010 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Vertex Pharmaceuticals Incorporated

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

VX-770

Arm Type

Experimental

Arm Title

Midazolam

Arm Type

Experimental

Arm Title

Rosiglitazone

Arm Type

Experimental

Arm Title

Fluconazole

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

VX-770

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

VX-770

Intervention Description

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.

Primary Outcome Measure Information:

Title

Midazolam, Rosiglitazone and VX 770 pharmacokinetic (PK) parameter

Time Frame

11 days

Title

Fluconazole and VX 770 PK parameters

Time Frame

10 days

Secondary Outcome Measure Information:

Title

1´ hydroxy midazolam PK parameters in plasma

Time Frame

11 days

Title

Safety as measured by adverse events, physical examinations, vital signs, ECGs, and clinically significant laboratory assessments

Time Frame

21 days

Title

Metabolites PK parameters in plasma

Time Frame

21 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

H. Frank Farmer, MD

Organizational Affiliation

Covance CRU, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Covan CRU, Inc.

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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