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

Vertex Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment; Healthy

Treatments: Drug: lumacaftor 200 mg q12h + ivacaftor 250 mg q12h

Study type: Interventional

Funder types: Industry

Identifiers

NCT01888393

VX13-809-010

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

23 participants in 2 patient groups

Group A

Experimental group

Description:

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

Treatment:

Drug: lumacaftor 200 mg q12h + ivacaftor 250 mg q12h

Group B

Experimental group

Description:

Approximately 12 healthy subjects (male and female)

Treatment:

Drug: lumacaftor 200 mg q12h + ivacaftor 250 mg q12h