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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01899105
• Other study ID #: VX13-809-012
• Status: Completed
• Phase: Phase 1
• First received: July 10, 2013
• Last updated: April 2, 2014
• Start date: July 2013
• Est. completion date: August 2013

Study information

• Verified date: April 2014
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cystic Fibrosis

Intervention

Drug:
• lumacaftor

• ivacaftor

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic parameters of lumacaftor and ivacaftor, including Cmax, AUC0-tlast, and AUC0-8		up to 5 days	No
Secondary	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	Yes