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

NCT01888393 | Completed Phase 1 DMC

• 1 other identifier: VX13-809-010
• Study Type: interventional
• Target: 23
• Locations: 2 countries
• Sites: 2

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.

Conditions

Hepatic Impairment; Healthy

Keywords

pharmacokinetics, hepatic impairment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (2)

Group A

EXPERIMENTAL

Approximately 12 subjects (male and female) with moderate hepatic impairment

Drug: lumacaftor 200 mg q12h + ivacaftor 250 mg q12h

Group B

EXPERIMENTAL

Approximately 12 healthy subjects (male and female)

Drug: lumacaftor 200 mg q12h + ivacaftor 250 mg q12h

Interventions

lumacaftor 200 mg q12h + ivacaftor 250 mg q12h DRUG

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vertex Pharmaceuticals Incorporated: lead

Study Sites (2)

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Bratislava, Slovakia

Location

MeSH Terms

Interventions

lumacaftor; ivacaftor

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: June 27, 2013
• Study Start: June 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

SL (1); CZ (1)