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Completed

NCT Number: NCT01060566

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

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covan CRU, Inc.

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

VX-770

Drug

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.

Primary outcomes

  1. Midazolam, Rosiglitazone and VX 770 pharmacokinetic (PK) parameter

    Time frame: 11 days

  2. Fluconazole and VX 770 PK parameters

    Time frame: 10 days

Secondary outcomes

  1. 1´ hydroxy midazolam PK parameters in plasma

    Time frame: 11 days

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

    Time frame: 21 days

  3. Metabolites PK parameters in plasma

    Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 2, 2010
Registry last updated
Apr 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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