NCT04727138

3-part Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EXS21546

3-part Study to Assess Safety, Tolerability, PK and PD of Single and Multiple Ascending Doses of EXS21546, and to Evaluate the Relative Bioavailability of 2 Formulations, in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Exscientia AI Limited · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A 3-part Study to Assess Safety, Tolerability, PK and PD of Single (Part 1) and Multiple (Part 2) Ascending Doses of EXS21546, and to Evaluate the Relative Bioavailability of a Solid Dose Formulation Compared to a Powder for Oral Suspension (Part 3), in Healthy Male Subjects.

Detailed description

Part 1 is a randomised, double-blind, placebo-controlled, SAD study with a food effect assessment. Part 2 is a randomised, double-blind, placebo controlled, MAD study over 14 days. In order to explore the potential CYP3A4 inducer effect, midazolam will also be administered in one cohort. Part 3 is a 3-period, open label, randomised, sequential study. Each subject will receive solid dose formulation and powder for oral suspension in a randomised manner.

Conditions

• Oncology

Interventions

Type	Name	Description
DRUG	EXS21546 Powder for Oral Suspension	EXS21546 Powder for Oral Suspension
DRUG	EXS21546 Granule in Capsule	EXS21546 Granule in Capsule
OTHER	Midazolam	Interaction
OTHER	Food Effect	Fed/Fasted
OTHER	Placebo Powder for Oral Suspension	Placebo Powder for Oral Suspension

Timeline

• Start date: 2020-12-08
• Primary completion: 2022-04-16
• Completion: 2022-05-12
• First posted: 2021-01-27
• Last updated: 2022-05-16

Locations

1 site across 1 country: United Kingdom