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Drug & research development » Clinical trials » NCT01153542

Study of VX-770 on Desipramine

Official title: An Open-Label Phase 1 Study to Examine the Effect of VX 770 on Desipramine in Healthy Subjects

Clinical Trials gov number: NCT01153542

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Purpose: To evaluate the effects of ivacaftor on desipramine.

Phase: 1

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

Study sponsor: Vertex Pharmaceuticals Incorporated

  • Subjects must be male or female and between 18 and 55 years of age
  • Subject must have a body mass index from 18 to 30 kg/m2
  • Subject must be judged to be in good health

Intervention
Ivacaftor

Geographical Location
United States

Number of Participants
≤50 (18-55 years)

Primary Endpoint

Ivacaftor and desipramine pharmacokinetic parameters (3 weeks)

Secondary Endpoint

  • Safety as measured by adverse events, vital signs, electrocardiograms and clinically significant laboratory assessments (3 weeks)
  • Metabolites pharmacokinetic parameters in plasma (3 weeks)

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  • Experimental: VX-770

In period 2, subjects will receive 150 mg VX-770 q12h orally from the morning of Day 1 through the evening of Day 9. Subjects will receive 50 mg Desipramine as a single dose on Day 5 of period 2.

  • Experimental: desipramine

In period 1, subjects will receive a single oral dose of desipramine on Day 1.

In period 2, subjects will receive 150 mg VX-770 q12h orally from the morning of Day 1 through the evening of Day 9. Subjects will receive 50 mg Desipramine as a single dose on Day 5 of period 2.

View Trial Results