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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Vertex Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Cystic Fibrosis

Treatments

Drug: Ivacaftor
Drug: Rifampin
Drug: Itraconazole
Drug: Ciprofloxacin
Drug: Lumacaftor

Study type

Interventional

Funder types

Industry

Identifiers

NCT01768663
VX12-809-009

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts 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)

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 4 patient groups

Treatment Group (Cohort 1)
Experimental group
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.
Treatment:
Drug: Lumacaftor
Drug: Ciprofloxacin
Drug: Ivacaftor
Treatment Group (Cohort 2)
Experimental group
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.
Treatment:
Drug: Lumacaftor
Drug: Itraconazole
Drug: Ivacaftor
Treatment Group (Cohort 3)
Experimental group
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.
Treatment:
Drug: Lumacaftor
Drug: Rifampin
Drug: Ivacaftor
Treatment Group (Cohort 4)
Experimental group
Description:
Subjects will take a single dose of lumacaftor in combination with ivacaftor on 3 occasions separated by 7 days.
Treatment:
Drug: Lumacaftor
Drug: Ivacaftor

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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