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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

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Lumacaftor

Ivacaftor

Ciprofloxacin

Itraconazole

Rifampin

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Treatment Group (Cohort 1)

Treatment Group (Cohort 2)

Treatment Group (Cohort 3)

Treatment Group (Cohort 4)

Arm Description

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.

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.

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.

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

Outcomes

Primary Outcome Measures

Cohorts 1-3: PK parameters including Cmax, and AUC from time of dosing to time tau of lumacaftor and ivacaftor in the absence and presence of ciprofloxacin, itraconazole, and rifampin

Cohort 4: Change in lung function from before treatment with lumacaftor/ivacaftor to after treatment with lumacaftor/ivacaftor.

Secondary Outcome Measures

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

Cohort 4: PK parameters, including Cmax of lumacaftor/ivacaftor, and lung function

Full Information

NCT ID

NCT01768663

First Posted

January 11, 2013

Last Updated

November 14, 2013

Sponsor

Vertex Pharmaceuticals Incorporated

1. Study Identification

Unique Protocol Identification Number

NCT01768663

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vertex Pharmaceuticals Incorporated

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group (Cohort 1)

Arm Type

Experimental

Arm Description

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.

Arm Title

Treatment Group (Cohort 2)

Arm Type

Experimental

Arm Description

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.

Arm Title

Treatment Group (Cohort 3)

Arm Type

Experimental

Arm Description

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.

Arm Title

Treatment Group (Cohort 4)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Lumacaftor

Other Intervention Name(s)

VX-809

Intervention Description

tablet, 200mg taken every 12 hours

Intervention Type

Drug

Intervention Name(s)

Ivacaftor

Other Intervention Name(s)

VX-770

Intervention Description

tablet, 250mg taken every 12 hours

Intervention Type

Drug

Intervention Name(s)

Ciprofloxacin

Intervention Description

750 mg taken every 12 hours

Intervention Type

Drug

Intervention Name(s)

Itraconazole

Intervention Description

200mg taken once daily

Intervention Type

Drug

Intervention Name(s)

Rifampin

Intervention Description

600mg taken once daily

Primary Outcome Measure Information:

Title

Cohorts 1-3: PK parameters including Cmax, and AUC from time of dosing to time tau of lumacaftor and ivacaftor in the absence and presence of ciprofloxacin, itraconazole, and rifampin

Time Frame

up to 24 days

Title

Cohort 4: Change in lung function from before treatment with lumacaftor/ivacaftor to after treatment with lumacaftor/ivacaftor.

Time Frame

up to 21 days

Secondary Outcome Measure Information:

Title

Time Frame

up to 31 days

Title

Cohort 4: PK parameters, including Cmax of lumacaftor/ivacaftor, and lung function

Time Frame

16 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Facility Information:

City

Evansville

State/Province

Indiana

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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