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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01888393
• Other study ID #: VX13-809-010
• Status: Completed
• Phase: Phase 1
• First received: June 20, 2013
• Last updated: November 18, 2013
• Start date: June 2013
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationThe Czech Republic: State Institute of Drug ControlSlovakia: State Institute of Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy
• Hepatic Impairment
• Liver Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated

Countries where clinical trial is conducted

Czech Republic,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lumacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F		16 days	No
Primary	Ivacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F		16 days	No
Secondary	Lumacaftor metabolites pharmacokinetic parameters, including Cmax and AUC		16 days	No
Secondary	Ivacaftor metabolites pharmacokinetic parameters including Cmax, tmax, AUC		16 days	No
Secondary	Safety and tolerability as mentioned by adverse events, clinical laboratory values, standard electrocardiograms, Vital signs and pulse oximetry		21 days	Yes