NCT01899105

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2013

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 15, 2013

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

April 3, 2014

Status Verified

April 1, 2014

Enrollment Period

1 month

First QC Date

July 10, 2013

Last Update Submit

April 2, 2014

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic parameters of lumacaftor and ivacaftor, including Cmax, AUC0-tlast, and AUC0-∞

    up to 5 days

Secondary Outcomes (1)

  • 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

Study Arms (2)

Part A

EXPERIMENTAL

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

Drug: lumacaftorDrug: ivacaftor

Part B

EXPERIMENTAL

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

Drug: lumacaftorDrug: ivacaftor

Interventions

lumacaftorDRUG
Also known as: VX-809
Part APart B
ivacaftorDRUG
Also known as: VX-770
Part APart B

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Daytona Beach, Florida, United States

Location

Related Publications (2)

  • Heneghan M, Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2023 Nov 20;11(11):CD010966. doi: 10.1002/14651858.CD010966.pub4.

    PMID: 37983082DERIVED

  • Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD010966. doi: 10.1002/14651858.CD010966.pub3.

    PMID: 33331662DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

lumacaftorivacaftor

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2013

First Posted

July 15, 2013

Study Start

July 1, 2013

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

April 3, 2014

Record last verified: 2014-04

Locations

US(1)