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

Sponsor
Vertex Pharmaceuticals Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT01888393
Collaborator
(none)
23
2
2
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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
  • Drug: lumacaftor 200 mg q12h + ivacaftor 250 mg q12h
Phase 1

Study Design

Study Type:
Interventional
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 :
Jun 1, 2013
Actual Primary Completion Date :
Nov 1, 2013
Actual Study Completion Date :
Nov 1, 2013

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

  1. Lumacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F [16 days]

  2. Ivacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F [16 days]

Secondary Outcome Measures

  1. Lumacaftor metabolites pharmacokinetic parameters, including Cmax and AUC [16 days]

  2. Ivacaftor metabolites pharmacokinetic parameters including Cmax, tmax, AUC [16 days]

  3. Safety and tolerability as mentioned by adverse events, clinical laboratory values, standard electrocardiograms, Vital signs and pulse oximetry [21 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
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

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.
Responsible Party:
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT01888393
Other Study ID Numbers:
  • VX13-809-010
First Posted:
Jun 27, 2013
Last Update Posted:
Nov 19, 2013
Last Verified:
Nov 1, 2013
Keywords provided by Vertex Pharmaceuticals Incorporated
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 19, 2013