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

A Phase 1, Open Label Study to Assess the Pharmacokinetics and Safety of Multiple Doses of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01888393

Enrollment

Registered

2013-06-27

Start date

2013-06-30

Completion date

2013-11-30

Last updated

2013-11-19

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

Conditions

Healthy, Hepatic Impairment

Keywords

pharmacokinetics, hepatic impairment

Brief summary

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.

Interventions

DRUGlumacaftor 200 mg q12h + ivacaftor 250 mg q12h

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Lumacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F	16 days
Ivacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F	16 days

Secondary

Measure	Time frame
Lumacaftor metabolites pharmacokinetic parameters, including Cmax and AUC	16 days
Ivacaftor metabolites pharmacokinetic parameters including Cmax, tmax, AUC	16 days
Safety and tolerability as mentioned by adverse events, clinical laboratory values, standard electrocardiograms, Vital signs and pulse oximetry	21 days

Countries

Czechia, Slovakia

Outcome results

None listed

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