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Completed

NCT Number: NCT01899105

A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor

This study is designed to investigate the effect of food on the relative bioavailability of 2 different strengths of fixed-dose combinations of lumacaftor and ivacaftor tablet formulations.

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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

Daytona Beach, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male and female subjects as defined in the protocol
  • Subjects who weigh >50 kg at Screening

Exclusion criteria

  • History of any illness or condition that might confound the results of the study or pose an additional risk to the subject upon administration of study drug - Positive for hepatitis B,C, or HIV
  • Standard 12-lead ECG demonstrating QTc >450 msec for male subjects and >480 msec for female subjects at the Screening Visit
  • Abnormal renal function as defined in the protocol at Screening
  • Forced expiratory volume in 1 second (FEV1) <80% predicted at the Screening Visit
  • Blood donation (of approximately 1 pint [500 mL] or more) within 56 days before the first dose of study drug
  • Treatment with an investigational drug or device within 30 days or 5 half-lives preceding the first dose of study drug

Treatment and study plan

Lumacaftor

Drug

Other names: VX-809

Ivacaftor

Drug

Other names: VX-770

Primary outcomes

  1. Pharmacokinetic parameters of lumacaftor and ivacaftor, including Cmax, AUC0-tlast, and AUC0-∞

    Time frame: up to 5 days

Secondary outcomes

  1. Safety and tolerability as assessed by adverse events (AEs), laboratory assessments (serum chemistry and hematology), vital signs, standard 12-lead electrocardiograms (ECGs), and spirometry

    Time frame: up to 25 days

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study title

A Phase 1, Randomized, Single-Dose, Open-Label Crossover Study to Investigate the Effect of Food on the Relative Bioavailability of 2 Fixed-Dose Combinations of Lumacaftor and Ivacaftor Tablet Formulations in Healthy Adult Subjects

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 15, 2013
Registry last updated
Apr 3, 2014

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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