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

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Cystic Fibrosis

Treatments: Drug: ivacaftor; Drug: lumacaftor

Study type: Interventional

Funder types: Industry

Identifiers

NCT01899105

VX13-809-012

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

28 participants in 2 patient groups

Part A

Experimental group

Description:

A single dose of 2 fixed-dose combination tablets of 200mg lumacaftor/125mg ivacaftor (total of 400mg lumacaftor/250mg ivacaftor) in the fed state and fasted state with a 14 day washout period in between each dosing occasion

Treatment:

Drug: lumacaftor

Drug: ivacaftor

Part B

Experimental group

Description:

A single dose of 3 fixed-dose combination tablets of 200mg lumacaftor/83mg ivacaftor (total of 600mg lumacaftor and 250mg ivacaftor) in the fed with a 14 day washout period in between dosing occasions

Treatment:

Drug: lumacaftor

Drug: ivacaftor