Adjuvants, Anesthesia

Central Nervous System Depressants

Psychotropic Drugs

All Drugs and Chemicals

Midazolam

Anesthetics

Hypnotics and Sedatives

Anti-Anxiety Agents

Anesthetics, Intravenous

Anesthetics, General

GABA Modulators

Neurotransmitter Agents

EXS21546 Powder for Oral Suspension

EXS21546 Granule in Capsule

Food Effect

Placebo Powder for Oral Suspension

Phillip Evans

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.

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.

Part 1 and Part 2 are double blind. Part 3 is open label.

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

Number of participants with treatment emergent Adverse Events

EXS21546 and Metabolite Area under the plasma concentration versus time curve (AUC)

EXS21546 and Metabolite Peak Plasma Concentration (Cmax)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
3-part Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EXS21546	NCT04727138	Oncology	EXS21546 Powder... EXS21546 Granul... Midazolam Food Effect Placebo Powder ...	18 Years - 55 Years	Exscientia AI Limited
3-part Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EXS21546	NCT04727138	Oncology	EXS21546 Powder... EXS21546 Granul... Midazolam Food Effect Placebo Powder ...	18 Years - 55 Years	Exscientia AI Limited
3-part Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EXS21546	NCT04727138	Oncology	EXS21546 Powder... EXS21546 Granul... Midazolam Food Effect Placebo Powder ...	18 Years - 55 Years	Exscientia AI Limited

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