Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy Subjects
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Group A Approximately 12 subjects (male and female) with moderate hepatic impairment |
Drug: lumacaftor 200 mg q12h + ivacaftor 250 mg q12h
|
Experimental: Group B Approximately 12 healthy subjects (male and female) |
Drug: lumacaftor 200 mg q12h + ivacaftor 250 mg q12h
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
Group A: Subjects with Moderate Hepatic Impairment
-
Male and female 18 to 65 years of age (inclusive)
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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
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Male and female 18 to 65 years of age (inclusive)
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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
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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
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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
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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
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Other causes of hepatic impairment not related to parenchymal disorder and/or disease of the liver
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Severe hepatic encephalopathy
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Type 1 diabetes mellitus or evidence of poorly controlled type 2 diabetes
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Hepatocellular carcinoma, HIV, hepatitis B/C
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Significant renal dysfunction
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Solid organ or bone marrow transplantation
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History of regular alcohol consumption, drug abuse or regular smoking
Group B: Healthy subjects
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Praha | Czech Republic | |||
2 | Bratislava | Slovakia |
Sponsors and Collaborators
- Vertex Pharmaceuticals Incorporated
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VX13-809-010