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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-08

Study Completion Date

2022-05-12

Brief Summary

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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.

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Detailed Description

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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

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Oncology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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

Study Groups

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EXS21546 Powder for Oral Suspension

Group Type EXPERIMENTAL

EXS21546 Powder for Oral Suspension

Intervention Type DRUG

EXS21546 Powder for Oral Suspension

Midazolam

Intervention Type OTHER

Interaction

Food Effect

Intervention Type OTHER

Fed/Fasted

Placebo

Placebo Powder for Oral Suspension

Group Type PLACEBO_COMPARATOR

Midazolam

Intervention Type OTHER

Interaction

Food Effect

Intervention Type OTHER

Fed/Fasted

Placebo Powder for Oral Suspension

Intervention Type OTHER

Placebo Powder for Oral Suspension

EXS21546 Granule in Capsule

Group Type EXPERIMENTAL

EXS21546 Granule in Capsule

Intervention Type DRUG

EXS21546 Granule in Capsule

Food Effect

Intervention Type OTHER

Fed/Fasted

Interventions

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EXS21546 Powder for Oral Suspension

Intervention Type DRUG

EXS21546 Granule in Capsule

Intervention Type DRUG

Midazolam

Interaction

Intervention Type OTHER

Food Effect

Fed/Fasted

Intervention Type OTHER

Placebo Powder for Oral Suspension

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes