Pharmacokinetic Study of Icenticaftor in Participants With Hepatic Impairment

NCT04587622 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-06-20

No results posted yet for this study

Summary

The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic pharmacokinetics, safety, and tolerability of icenticaftor in participants with varying degrees of hepatic impairment.

Conditions

Hepatic Failure

Interventions

DRUG

Icenticaftor

Single oral dose of 300 mg of icenticaftor (QBW251)

Sponsors & Collaborators

Novartis Pharmaceuticals
lead INDUSTRY

Study Design

Allocation: NON_RANDOMIZED
Purpose: TREATMENT
Masking: NONE
Model: PARALLEL

Eligibility

Min Age: 18 Years
Max Age: 75 Years
Sex: ALL
Healthy Volunteers: Yes

Timeline & Regulatory

Start: 2020-10-30
Primary Completion: 2022-09-15
Completion: 2022-09-15
FDA Drug: Yes

Countries

United States

Study Locations

More Related Trials

Entities

Companies

Novartis Pharmaceuticals

Summary

Conditions

Interventions

Sponsors & Collaborators

Study Design

Eligibility

Timeline & Regulatory

Countries

Study Locations

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