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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

NCT ID: NCT01768663

Last Updated: 2013-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Brief Summary

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The purpose of this study is 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 lumacaftor in combination with ivacaftor on lung function.

Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Group (Cohort 1)

Subjects will take lumacaftor in combination with ivacaftor for 14 days. Beginning on Day 15, subjects will take lumacaftor in combination with ivacaftor and ciprofloxacin through Day 21.

Group Type EXPERIMENTAL

Lumacaftor

Intervention Type DRUG

tablet, 200mg taken every 12 hours

Ivacaftor

Intervention Type DRUG

tablet, 250mg taken every 12 hours

Ciprofloxacin

Intervention Type DRUG

750 mg taken every 12 hours

Treatment Group (Cohort 2)

Subjects will take lumacaftor in combination with ivacaftor for 14 days. Beginning on Day 15, subjects will take lumacaftor in combination with ivacaftor and itraconazole through Day 21.

Group Type EXPERIMENTAL

Lumacaftor

Intervention Type DRUG

tablet, 200mg taken every 12 hours

Ivacaftor

Intervention Type DRUG

tablet, 250mg taken every 12 hours

Itraconazole

Intervention Type DRUG

200mg taken once daily

Treatment Group (Cohort 3)

Subjects will take lumacaftor in combination with ivacaftor for 14 days. Beginning on Day 15, subjects will take lumacaftor in combination with ivacaftor and rifampin through Day 24.

Group Type EXPERIMENTAL

Lumacaftor

Intervention Type DRUG

tablet, 200mg taken every 12 hours

Ivacaftor

Intervention Type DRUG

tablet, 250mg taken every 12 hours

Rifampin

Intervention Type DRUG

600mg taken once daily

Treatment Group (Cohort 4)

Subjects will take a single dose of lumacaftor in combination with ivacaftor on 3 occasions separated by 7 days.

Group Type EXPERIMENTAL

Lumacaftor

Intervention Type DRUG

tablet, 200mg taken every 12 hours

Ivacaftor

Intervention Type DRUG

tablet, 250mg taken every 12 hours

Interventions

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Lumacaftor

tablet, 200mg taken every 12 hours

Intervention Type DRUG

Ivacaftor

tablet, 250mg taken every 12 hours

Intervention Type DRUG

Ciprofloxacin

750 mg taken every 12 hours

Intervention Type DRUG

Itraconazole

200mg taken once daily

Intervention Type DRUG

Rifampin

600mg taken once daily

Intervention Type DRUG

Other Intervention Names

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VX-809 VX-770

Eligibility Criteria

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Inclusion Criteria

* Male and female subjects must be between the ages of 18 and 55 years, inclusive
* Body mass index (BMI) of 18 to 31 kg/m2, inclusive, and a total body weight \>50 kg.

Exclusion Criteria

* History of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject. This may include, but is not limited to, a history of relevant drug or food allergies; history of cardiovascular or central nervous system disease; history or presence of clinically significant pathology; or history of mental disease.
* History of febrile illness within 5 days before the first dose.
* History of Gilbert's syndrome
* Abnormal renal function as defined at screening
* Blood donation of approximately 1 pint (500 mL) within 56 days before study drug administration
* Treatment with an investigational drug within 30 days or 5 half-lives (or as determined by the local requirements, whichever is longer) preceding the first dose of study drug
* Known hypersensitivity or prior adverse reaction to ciprofloxacin, or any member of the quinolone class of antimicrobial agents (Cohort 1 only); itraconazole, or to any of the other azoles (Cohort 2 only); rifampin, or to any of the rifamycins (Cohort 3 only)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Evansville, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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VX12-809-009

Identifier Type: -

Identifier Source: org_study_id