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lumacaftor q12h+ ivacaftor q12h

Phase 1

Hepatic Impairment | Small molecule | Gastrointestinal |Vertex Pharmaceuticals Incorporated|Last Updated: Nov 19, 2013

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment23

FDA Designations

No designations recorded

Clinical trial landscape

lumacaftor q12h+ ivacaftor q12h · 1 trial · 2 indications

Phase 1 1
NCT01888393Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy SubjectsHepatic Impairment
COMPLETED23 Analytics
PHASE1COMPLETED
Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy Subjects
Hepatic Impairment
NCT0188839323
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Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
Group AEXPERIMENTALApproximately 12 subjects (male and female) with moderate hepatic impairment
Group BEXPERIMENTALApproximately 12 healthy subjects (male and female)

Interventions

NameTypeDescription
lumacaftor 200 mg q12h + ivacaftor 250 mg q12hDRUG -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

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 w...

Countries:CzechiaSlovakia
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Frequently asked questions about lumacaftor q12h+ ivacaftor q12h

What is lumacaftor q12h + ivacaftor q12h used for?

Lumacaftor q12h + ivacaftor q12h is a small molecule combination being studied for hepatic impairment. It is currently in Phase 1 clinical development by Vertex Pharmaceuticals Incorporated. The combination is not approved and remains investigational for this use.

Who makes lumacaftor q12h + ivacaftor q12h?

Vertex Pharmaceuticals Incorporated (VRTX) is developing lumacaftor q12h + ivacaftor q12h. The company is conducting clinical trials to evaluate the combination in subjects with moderate hepatic impairment and healthy subjects.

What phase is lumacaftor q12h + ivacaftor q12h in?

Lumacaftor q12h + ivacaftor q12h is in Phase 1 clinical development. One Phase 1 trial has been completed, with a total enrollment of 23 participants. The drug is investigational and has not been approved for hepatic impairment.

What clinical trials is lumacaftor q12h + ivacaftor q12h in?

Lumacaftor q12h + ivacaftor q12h was studied in trial NCT01888393, titled 'Study of Lumacaftor in Combination With Ivacaftor in Subjects With Moderate Hepatic Impairment and Healthy Subjects.' This Phase 1 trial enrolled 23 participants and was completed in Czechia and Slovakia.

Is lumacaftor q12h + ivacaftor q12h the same as lumacaftor and ivacaftor?

Lumacaftor q12h + ivacaftor q12h is a combination of lumacaftor and ivacaftor, dosed every 12 hours. The trial NCT01888393 evaluates this specific dosing regimen in subjects with moderate hepatic impairment and healthy subjects.