NCT04351165

BA Study of IMP4297 (20mg vs 10mg) in Healthy Male Subjects

An Open-Label, Randomized, Single-Dose, 2-Way Crossover Study to Compare the Bioavailability of Two IMP4297 Formulations (20 mg Capsules and 10 mg Capsules) After Single Oral Administration of 100 mg IMP4297 Under Fasted Condition in Healthy Male Subjects

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

Summary

An open-label, randomized, single-dose, 2-way crossover study to compare the bioavailability of two IMP4297 formulations (20 mg capsules and 10 mg capsules) after single oral administration of 100 mg IMP4297 under fasted condition in healthy male subjects

Detailed description

This will be an open-label, randomized, single-dose, 2-way crossover study to compare the bioavailability of two IMP4297 formulations (10 mg capsules and 20 mg capsules) after single oral administration of 100 mg IMP4297 under fasted condition in healthy male subjects. It will be conducted at one site, and approximately a total of 18 subjects will be enrolled. Subjects will be randomized to one of the 2 treatment sequences according to a computer-generated randomization schedule. Each treatment sequence will consist of 2 periods, separated by a washout period of at least 7 days between each period.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	IMP4297	IMP4297 10mg/capsule; IMP4297 20mg/capsule;

Timeline

• Start date: 2020-10-29
• Primary completion: 2021-02-11
• Completion: 2021-04-30
• First posted: 2020-04-17
• Last updated: 2021-08-24

Locations

1 site across 1 country: Australia