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Drug & research development » Clinical trials » NCT01216046

Drug-Drug Interaction Study of VX-770 and VX-809 in Healthy Subjects

Official title: A Phase 1, Randomized, Double-Blind, Placebo Controlled, Multiple-Dose, Dose-Escalation, Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects

Clinical Trials gov number: NCT01216046

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Purpose: To assess the pharmacokinetics and safety of VX-809 and ivacaftor alone and in combination in healthy subjects.

Phase: 1

Type: Interventional, randomized, double-blind, crossover assignment, parallel assignment

Study sponsor: Vertex Pharmaceuticals Incorporated

  • Body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive
  • Subjects of child bearing potential and who are sexually active must meet the contraception requirements
  • Female subject must have a negative serum pregnancy test at screening and Day -1

Intervention
Ivacaftor, Lumacaftor

Geographical Location
United States

Number of Participants
≤50 (18-55 years)

Primary Endpoint

  • PK parameters of VX-809 and its metabolite in plasma in the presence and absence of ivacaftor (70 days)
  • PK parameters (including concentration, exposure and half-life) of ivacaftor and its metabolites in plasma in the presence and absence of VX 809 (70 days)

Secondary Endpoint

  • Safety and tolerability as measured by adverse events and clinically significant changes in laboratory values (clinical chemistry, hematology, coagulation, and urinalysis), electrocardiograms, and vital signs (70 days)

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  • Experimental: Treatment Arm

Subjects randomized to study drug will take VX-809 (once daily) for 14 days followed by a 14 day washout. Next subjects will take VX-770 (every 12 hours) for 14 days followed by a 14 day washout. Lastly, subjects will take both VX-809 and VX-770 for 14 days.

  • Placebo Comparator: Placebo Arm

Subjects randomized to placebo will take VX-809 placebo (once daily) for 14 days followed by a 14 day washout. Next subjects will take VX-770 placebo (every 12 hours)  for 14 days followed by a 14 day washout. Lastly, subjects will take both VX-809 and VX-770 placebo for 14 days.

View Trial Results