Study of Lumacaftor in Combination With Ivacaftor in Subj... | NCT01888393

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

NCT01888393

Sponsor

Vertex Pharmaceuticals Incorporated

Status

Completed

Last Update Posted

Nov 19, 2013Estimated

Enrollment

23Actual

Phase

Phase 1

Conditions

Hepatic Impairment
Healthy

Interventions

lumacaftor 200 mg q12h + ivacaftor 250 mg q12h

Countries

Czechia
Slovakia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2013

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Jun 20, 2013

First Submission Date that Met QC Criteria

Jun 26, 2013

First Posted Date

Jun 27, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2013

Last Update Posted Date

Nov 19, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
lumacaftor 200 mg q12h + ivacaftor 250 mg q12h	Drug		Group A Group B

Measure	Description	Time Frame
Lumacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F		16 days
Ivacaftor pharmacokinetic parameters, including Cmax, tmax, AUC, Vd, CL/F		16 days

Measure	Description	Time Frame
Lumacaftor metabolites pharmacokinetic parameters, including Cmax and AUC		16 days
Ivacaftor metabolites pharmacokinetic parameters including Cmax, tmax, AUC		16 days

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Prague			Czechia

ID	Term
C569105	lumacaftor
C545203	ivacaftor