A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor

A Phase 1, Randomized, Single-Dose, Open-Label Crossover Study to Investigate the Effect of Food on the Relative Bioavailability of 2 Fixed-Dose Combinations of Lumacaftor and Ivacaftor Tablet Formulations in Healthy Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01899105

Enrollment

Registered

2013-07-15

Start date

2013-07-31

Completion date

2013-08-31

Last updated

2014-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Brief summary

This study is designed to investigate the effect of food on the relative bioavailability of 2 different strengths of fixed-dose combinations of lumacaftor and ivacaftor tablet formulations.

Interventions

DRUGlumacaftor

DRUGivacaftor

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and female subjects as defined in the protocol * Subjects who weigh \>50 kg at Screening

Exclusion criteria

* History of any illness or condition that might confound the results of the study or pose an additional risk to the subject upon administration of study drug - Positive for hepatitis B,C, or HIV * Standard 12-lead ECG demonstrating QTc \>450 msec for male subjects and \>480 msec for female subjects at the Screening Visit * Abnormal renal function as defined in the protocol at Screening * Forced expiratory volume in 1 second (FEV1) \<80% predicted at the Screening Visit * Blood donation (of approximately 1 pint \[500 mL\] or more) within 56 days before the first dose of study drug * Treatment with an investigational drug or device within 30 days or 5 half-lives preceding the first dose of study drug

Design outcomes

Primary

Measure	Time frame
Pharmacokinetic parameters of lumacaftor and ivacaftor, including Cmax, AUC0-tlast, and AUC0-∞	up to 5 days

Secondary

Measure	Time frame
Safety and tolerability as assessed by adverse events (AEs), laboratory assessments (serum chemistry and hematology), vital signs, standard 12-lead electrocardiograms (ECGs), and spirometry	up to 25 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026