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NCT Number: NCT01888393

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

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.

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Key information

Conditions

Hepatic Impairment Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Prague, Czechia

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lumacaftor 200 mg q12h + ivacaftor 250 mg q12h

Drug

Primary outcomes

  1. Lumacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F

    Time frame: 16 days

  2. Ivacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F

    Time frame: 16 days

Secondary outcomes

  1. Lumacaftor metabolites pharmacokinetic parameters, including Cmax and AUC

    Time frame: 16 days

  2. Ivacaftor metabolites pharmacokinetic parameters including Cmax, tmax, AUC

    Time frame: 16 days

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

    Time frame: 21 days

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 27, 2013
Registry last updated
Nov 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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