NCT05428150

Randomized, Crossover, Multi-Dose Pharmacokinetics of EXCL-100 Pirfenidone-Sustained Release Tablet and Esbriet in Healthy Volunteers

Randomized, Crossover, Multi-Dose, Steady State, Comparative Pharmacokinetics and Relative Bioavailability Study of EXCL-100 Pirfenidone-Sustained Release Tablet (EXCL-100), and Esbriet® in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Excalibur Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open-label, 2-treatment, 2-period, crossover steady state study conducted to evaluate the comparative bioavailability/bioequivalence of pirfenidone after multi-dose administration of EXCL-100 at doses of 1200 mg (600 mg x 2) in the fed state, and Esbriet® 801 mg (267 mg capsule x 3) given in the fed state, to healthy volunteers.

Detailed description

After signing the Institutional Review Board (IRB) approved Informed Consent Form (ICF), subjects will undergo a screening evaluation up to 28 days prior to dosing on Day 1 of Period 1. Subjects who satisfy the screening evaluation and who meet the inclusion and exclusion criteria will be enrolled in the study. Subjects will receive multiple doses of study drug according to their assigned sequence of treatment in Period 1. After completion of study procedures, a washout period will be completed prior to crossover to Period 2 to receive the second treatment in their sequence. Subjects will receive Regimens A (Esbriet® 801 mg three times daily with meals for 3 days) and B (EXCL-100, 1200 mg twice daily with meals) according to the randomization schedule. Pharmacokinetic (PK) blood samples will be taken on multiple days during the study periods.

Conditions

• Idiopathic Pulmonary Fibrosis

Interventions

Type	Name	Description
DRUG	Esbriet 267 MG Oral Capsule	Reference Formulation
DRUG	EXCL-100, 600 MG Oral Tablet	Test Formulation

Timeline

• Start date: 2022-08-08
• Primary completion: 2022-09-25
• Completion: 2022-09-25
• First posted: 2022-06-22
• Last updated: 2022-11-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study