MedDataX Logo

Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy Subjects

NCT ID: NCT01888393

Last Updated: 2013-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is designed to evaluate the pharmacokinetics (PK) and safety of multiple doses of lumacaftor in combination with ivacaftor in subjects with moderate hepatic impairment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatic Impairment Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

pharmacokinetics, hepatic impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group A

Approximately 12 subjects (male and female) with moderate hepatic impairment

Group Type EXPERIMENTAL

lumacaftor 200 mg q12h + ivacaftor 250 mg q12h

Intervention Type DRUG

Group B

Approximately 12 healthy subjects (male and female)

Group Type EXPERIMENTAL

lumacaftor 200 mg q12h + ivacaftor 250 mg q12h

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

lumacaftor 200 mg q12h + ivacaftor 250 mg q12h

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Group A: Subjects with Moderate Hepatic Impairment

* Male and female 18 to 65 years of age (inclusive)
* Satisfy the criteria for moderate hepatic impairment defined as a Child Pugh total score of 7 to 9 (Child Pugh Class B) at the Screening Visit
* Willing and able to comply with schedule visits, treatment, laboratory tests, and contraceptive guidelines.

Group B: Healthy subjects

* Male and female 18 to 65 years of age (inclusive)
* Healthy subjects with no clinically relevant abnormalities identified by a detailed medical history, complete physical examination, including blood pressure and pulse rate measurement, standard 12-lead ECG, and clinical laboratory tests
* Willing and able to comply with schedule visits, treatment, laboratory tests, contraceptive guidelines and other study procedures

Exclusion Criteria

Group A: Subjects with Moderate Hepatic Impairment

* 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
* Have fluctuating or rapidly deteriorating hepatic function by history or as indicated by significant variations in or worsening of clinical and/or laboratory signs of hepatic impairment within 6 months before the Screening Visit
* Other causes of hepatic impairment not related to parenchymal disorder and/or disease of the liver
* Severe hepatic encephalopathy
* Type 1 diabetes mellitus or evidence of poorly controlled type 2 diabetes
* Hepatocellular carcinoma, HIV, hepatitis B/C
* Significant renal dysfunction
* Solid organ or bone marrow transplantation
* History of regular alcohol consumption, drug abuse or regular smoking

Group B: Healthy subjects

* 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
* History of regular alcohol consumption, drug abuse or regular smoking
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Prague, , Czechia

Site Status

Bratislava, , Slovakia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Czechia Slovakia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VX13-809-010

Identifier Type: -

Identifier Source: org_study_id