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Drug & research development » Clinical trials » NCT01899105

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

Official 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

Clinical Trials gov number: NCT01899105

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Purpose: To investigate the effect of food on the relative bioavailability of 2 different strengths of fixed-dose combinations of VX-809 and ivacaftor tablet formulations.

Phase: 1

Type: Interventional, randomized, open-label, crossover assignment

Study sponsor: Vertex Pharmaceuticals Incorporated

  • Subjects who weigh >50 kg at screening
  • Healthy male and female subjects

Intervention
Ivacaftor, Lumacaftor

Geographical Location
United States

Number of Participants
≤50 (18-55 years)

Primary Endpoint

Pharmacokinetic parameters of lumacaftor and ivacaftor, including Cmax, AUC0-tlast, and AUC0-∞ (up to 5 days)

Secondary Endpoint

  • Safety and tolerability as assessed by adverse events (AEs), laboratory assessments (serum chemistry and hematology), vital signs, standard 12-lead electrocardiograms (ECGs), and spirometry (up to 25 days)

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  • Experimental: Part A

A single dose of 2 fixed-dose combination tablets of 200mg lumacaftor/125mg ivacaftor (total of 400mg lumacaftor/250mg ivacaftor) in the fed state and fasted state with a 14 day washout period in between each dosing occasion

  • Experimental: Part B

A single dose of 3 fixed-dose combination tablets of 200mg lumacaftor/83mg ivacaftor (total of 600mg lumacaftor and 250mg ivacaftor) in the fed with a 14 day washout period in between dosing occasions

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