NCT02095587

Duvelisib in Hepatically Impaired Subjects Compared to Healthy Subjects

A Phase 1, Open-Label, Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of Duvelisib in Subjects With Chronic Hepatic Impairment Compared to Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: SecuraBio · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

To evaluate the pharmacokinetics, safety, and tolerability of IPI-145 when administered to subjects with chronic hepatic impairment and in matched healthy subjects.

Detailed description

This is a nonrandomized, open-label, parallel-group, single oral dose study in subjects with chronic hepatic impairment and matched (age, sex, weight, BMI) healthy subjects. Subjects will be enrolled into 1 of 3 groups based on hepatic impairment grade: mild, moderate and normal hepatic function. An optional severe hepatic impairment group will enroll based on data from the mild and moderate hepatic impairment groups in comparison to matched healthy group. All subjects will receive a single oral dose of IPI-145 25 mg.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	IPI-145	25 mg single oral capsule

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-07-01
• Completion: 2014-10-01
• First posted: 2014-03-26
• Last updated: 2021-03-17

Locations

1 site across 1 country: United States