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

Oncology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04727138
• Other study ID #: EXS21546-001
• Status: Completed
• Phase: Phase 1
• Start date: December 8, 2020
• Est. completion date: May 12, 2022

Study information

• Verified date: May 2022
• Source: Exscientia Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: May 12, 2022
• Est. primary completion date: April 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Oncology

Intervention

Drug:
• EXS21546 Powder for Oral Suspension
EXS21546 Powder for Oral Suspension
• EXS21546 Granule in Capsule
EXS21546 Granule in Capsule

Other:
• Midazolam
Interaction
• Food Effect
Fed/Fasted
• Placebo Powder for Oral Suspension
Placebo Powder for Oral Suspension

Locations

Country	Name	City	State
United Kingdom	Quotient Sciences	Nottingham

Sponsors (2)

Lead Sponsor	Collaborator
Exscientia Limited	Quotient Sciences

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with treatment emergent Adverse Events	Number of participants with treatment emergent Adverse Events	1 month
Primary	EXS21546 and Metabolite Area under the plasma concentration versus time curve (AUC)	EXS21546 and Metabolite Area under the plasma concentration versus time curve (AUC)	17 days
Primary	EXS21546 and Metabolite Peak Plasma Concentration (Cmax)	EXS21546 and Metabolite Peak Plasma Concentration (Cmax)	17 days