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

Purpose

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.

Condition	Intervention	Phase
Cystic Fibrosis	Drug: VX-770	Phase 1

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

Resource links provided by NLM:

Genetics Home Reference related topics: cystic fibrosis

MedlinePlus related topics: Cystic Fibrosis

Drug Information available for: Midazolam hydrochloride Fluconazole Rosiglitazone Rosiglitazone Maleate Ivacaftor

U.S. FDA Resources

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:

Midazolam, Rosiglitazone and VX 770 pharmacokinetic (PK) parameter [ Time Frame: 11 days ] [ Designated as safety issue: No ]
Fluconazole and VX 770 PK parameters [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

1´ hydroxy midazolam PK parameters in plasma [ Time Frame: 11 days ] [ Designated as safety issue: No ]
Safety as measured by adverse events, physical examinations, vital signs, ECGs, and clinically significant laboratory assessments [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
Metabolites PK parameters in plasma [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	February 2010
Study Completion Date:	April 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: VX-770	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. Drug: 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.
Experimental: Midazolam	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.
Experimental: Rosiglitazone	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.
Experimental: Fluconazole	Drug: 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.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01060566

Locations

United States, Florida
Covan CRU, Inc.
Daytona Beach, Florida, United States, 32117

Sponsors and Collaborators

Vertex Pharmaceuticals Incorporated

Investigators

Principal Investigator:

H. Frank Farmer, MD

Covance CRU, Inc.

More Information

No publications provided

Responsible Party:	Medical Monitor, Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:	NCT01060566 History of Changes
Other Study ID Numbers:	VX09-770-010
Study First Received:	January 29, 2010
Last Updated:	April 15, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Midazolam
Fluconazole
Rosiglitazone
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses

Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antifungal Agents

ClinicalTrials.gov processed this record on June 17, 2013