Status:
COMPLETED
Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy Subjects
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Conditions:
Hepatic Impairment
Healthy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01888393
Start Date
June 1 2013
End Date
November 1 2013
Last Update
November 19 2013
Active Locations (2)
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1
Prague, Czechia
2
Bratislava, Slovakia