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

• Status: Recruiting
• Trial end date: 2021-12-23
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Exscientia Limited
• Collaborator: Quotient Sciences
• Treatments: Midazolam

Criteria

Inclusion Criteria:

• BMI 18.0 to 30.0 kg/m2

• Weight ≥60 kg

• Must adhere to contraception requirements

Exclusion Criteria:

• Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1

• Subjects who have previously been administered IMP in this study.

• Evidence of current SARS-CoV-2 infection

• History of any drug or alcohol abuse in the past 2 years

• Regular alcohol consumption in males >21 units per week

• A confirmed positive alcohol breath test at screening or admission

• Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission

• Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months

• Subjects with pregnant or lactating partners

• Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results

• Regimen L only: History of sleep apnea

• Subjects with a history of cholecystectomy or gall stones

• Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients

• Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active

• Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood