NCT02307461

Bioequivalence of Duvelisib and Food Effect on Pharmacokinetics of IPI-145

A Phase 1, Open-label, 2-Part Study to Evaluate the Bioequivalence of the Duvelisib Marker-Image Formulation to the Duvelisib Clinical-Trial Formulation and to Assess the Effect of Food on the Pharmacokinetics of IP Duvelisib in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: SecuraBio · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

To Evaluate the Bioequivalence of the two formulations of IPI-145 and the Effect of Food on the Pharmacokinetics of IPI-145

Detailed description

This Phase 1, randomized, open-label study of IPI-145 will be conducted in 2 parts. Part 1 will be conducted in 2 cohorts. Cohort 1 will consist of 32 healthy subjects, and Cohort 2 will consist of 52 healthy subjects. Subjects in each cohort will receive 2 doses of IPI under fasted conditions in a 2-period, 2-sequence crossover design. Dosing in Period 1 and Period 2 will be separated by at least 7 days. Part 2 is a 2-period, 2-sequence crossover design to assess the effect of a high-fat meal on the PK of the IPI-145 in 20 subjects. Subjects will receive single oral doses under fed (high-fat meal) and fasted conditions, separated by at least 7 days.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	IPI-145 (duvelisib)	High single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) high single oral dose
DRUG	IPI-145	Low single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) low single oral dose
DRUG	IPI-145	High single oral dose IPI-145 test formulation (capsule) with a high-fat meal and without food

Timeline

• Start date: 2014-11-01
• Primary completion: 2015-08-01
• Completion: 2015-09-01
• First posted: 2014-12-04
• Last updated: 2021-03-17

Locations

1 site across 1 country: United States