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Drug & research development » Clinical trials » NCT01768663

A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects

Official title: A Phase 1, Open-Label Study to Examine the Effect of Ciprofloxacin, Itraconazole, and Rifampin on the Pharmacokinetics of Lumacaftor in Combination With Ivacaftor in Healthy Adult Subjects

Clinical Trials gov number: NCT01768663

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Purpose: To examine the drug-drug interaction effects of ciprofloxacin, itraconazole, and rifampin on the pharmacokinetics of lumacaftor in combination with ivacaftor as well as to evaluate the potential effects of VX-809 in combination with ivacaftor on lung function.

Phase: 1

Type: Interventional, non-randomized, open-label, single group assignment

Study sponsor: Vertex Pharmaceuticals Incorporated

  • Body mass index of 18 to 31 kg/m2, inclusive, and a total body weight >50 kg

Intervention
ciprofloxacin, Ivacaftor, Lumacaftor, itraconazole, rifampin

Geographical Location
United States

Number of Participants
51-100 (18-55 years)

Primary Endpoint

Cohorts 1-3

  • PK parameters from time of dosing to time tau of lumacaftor and ivacaftor in the absence and presence of ciprofloxacin, itraconazole, and rifampin up to 24 days

Cohort 4

  • Change in lung function from before treatment with lumacaftor/ivacaftor to after treatment with lumacaftor/ivacaftor up to 21 days

Secondary Endpoint

Cohorts 1-4:

  • Safety and tolerability as measured by adverse events (AEs) and changes in laboratory test values (serum chemistry, hematology, coagulation, and urinalysis), vital signs, standard 12 lead electrocardiograms (ECGs), and spirometry up to 31 days

Cohort 4:

  • PK parameters, including Cmax of lumacaftor/ivacaftor, and lung function (16 days)

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  • Experimental: Treatment Group (Cohort 1)

Subjects will take lumacaftor (200 mg every 12 hours) in combination with ivacaftor (250 mg every 12 hours) for 14 days. Beginning on Day 15, subjects will take lumacaftor in combination with ivacaftor and ciprofloxacin (750 mg very 12 hours) through Day 21.

  • Experimental: Treatment Group (Cohort 2)

Subjects will take lumacaftor (200 mg every 12 hours) in combination with ivacaftor (250 mg every 12 hours) for 14 days. Beginning on Day 15, subjects will take lumacaftor in combination with ivacaftor and itraconazole (200 mg once daily) through Day 21.

  • Experimental: Treatment Group (Cohort 3)

Subjects will take lumacaftor (200 mg every 12 hours) in combination with ivacaftor (250 mg every 12 hours) for 14 days. Beginning on Day 15, subjects will take lumacaftor in combination with ivacaftor and rifampin (600 mg once daily) through Day 24.

  • Experimental: Treatment Group (Cohort 4)

Subjects will take a single dose of lumacaftor (200 mg every 12 hours) in combination with ivacaftor (250 mg every 12 hours) on 3 occasions separated by 7 days.

View Trial Results