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Drug & research development » Clinical trials » NCT01018368

Study of VX-770 and Rifampin in Healthy Male Subjects

Official title: An Open-Label Phase 1 Study to Examine the Effect of Multiple Doses of Rifampin on the Single-Dose Pharmacokinetics of VX 770 in Healthy Subjects

Clinical Trials gov number: NCT01018368

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Purpose: To evaluate the effects of multiple doses of rifampin on the single-dose pharmacokinetics of ivacaftor.

Phase: 1

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

Study sponsor: Vertex Pharmaceuticals Incorporated

  • Subject must have a body mass index from 18 to 30 kg/m2

Intervention
Ivacaftor, rifampin

Geographical Location
United States

Number of Participants
≤50 (18-55 years)

Primary Endpoint

Ivacaftor pharmacokinetic parameters (17 days)

Secondary Endpoint

  • VX 770 metabolite PK parameters in plasma (17 days)
  • Rifampin concentration at time zero (C0) and AUC at steady state (AUCtau) following the administration of multiple doses of rifampin (17 days)
  • Safety as measured by adverse events, physical examinations, vital signs, electrocardiograms, and clinically significant laboratory assessments (17 days)

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  • Experimental: VX-770

In Period 1, subjects will receive a single oral dose of VX-770 150 mg on Day 1. In Period 2, subjects will receive a single oral dose of VX-770 150 mg on Day 6.

  • Experimental: Rifampin

In Period 2, subjects will receive a daily oral dose of rifampin 600 mg on Days 1 through 10

View Trial Results