Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy Subjects
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ClinicalTrials.gov Identifier: NCT01888393 |
Recruitment Status :
Completed
First Posted : June 27, 2013
Last Update Posted : November 19, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatic Impairment Healthy | Drug: lumacaftor 200 mg q12h + ivacaftor 250 mg q12h | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Official Title: | 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 |
Study Start Date : | June 2013 |
Actual Primary Completion Date : | November 2013 |
Actual Study Completion Date : | November 2013 |

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)
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Drug: lumacaftor 200 mg q12h + ivacaftor 250 mg q12h |
- Lumacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F [ Time Frame: 16 days ]
- Ivacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F [ Time Frame: 16 days ]
- Lumacaftor metabolites pharmacokinetic parameters, including Cmax and AUC [ Time Frame: 16 days ]
- Ivacaftor metabolites pharmacokinetic parameters including Cmax, tmax, AUC [ Time Frame: 16 days ]
- Safety and tolerability as mentioned by adverse events, clinical laboratory values, standard electrocardiograms, Vital signs and pulse oximetry [ Time Frame: 21 days ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01888393
Czech Republic | |
Praha, Czech Republic | |
Slovakia | |
Bratislava, Slovakia |
Responsible Party: | Vertex Pharmaceuticals Incorporated |
ClinicalTrials.gov Identifier: | NCT01888393 |
Other Study ID Numbers: |
VX13-809-010 |
First Posted: | June 27, 2013 Key Record Dates |
Last Update Posted: | November 19, 2013 |
Last Verified: | November 2013 |
pharmacokinetics, hepatic impairment |
Liver Diseases Digestive System Diseases Ivacaftor |
Chloride Channel Agonists Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |