NCT05665283

A Single Dose BE Study of X-396 in Healthy Volunteers Under Fasted Conditions

A Randomized Open Label Crossover Single Dose Bioequivalency Study of Ensartinib Capsules in Healthy Volunteers Under Fasted Conditions

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Xcovery Holdings, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, Phase I single dose 2-part, crossover bioequivalence study under fasted conditions. The trial is designed to evaluate the pharmacokinetic parameters between single doses of 100mg ensartinib capsules manufactured by two different processes.

Detailed description

A Phase I, randomized, open-label single dose, 2-part, crossover bioequivalence study under fasted conditions to compare 100 mg capsules manufactured using the proposed commercial manufacturing process to the corresponding capsules which were utilized in the Phase III clinical study manufactured by a different process. A total of 32 healthy subjects were divided evenly and were randomized into 1 of the 2 treatment sequences (T-R or R-T) prior to Period 1 dosing. Subjects received the test product (100 mg ensartinib hydrochloride capsules manufactured with the registration stability process) or the reference product (100 mg ensartinib hydrochloride capsules utilized in the Phase 3 trial) according to their assigned treatment sequence. The single dose crossover study will have a minimum washout period of 14 days.

Conditions

• Bioequivalency

Interventions

Type	Name	Description
DRUG	Ensartinib Hydrochloride	oral ALK inhibitor

Timeline

• Start date: 2022-11-29
• Primary completion: 2023-01-18
• Completion: 2023-08-08
• First posted: 2022-12-27
• Last updated: 2024-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study