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

NCT04727138 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2022-05-16

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Quotient Sciences

    collaborator INDUSTRY

  • Exscientia AI Limited

    lead INDUSTRY

Principal Investigators

  • Phillip Evans · Quotient Sciences Principal Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-08
Primary Completion
2022-04-16
Completion
2022-05-12

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04727138 on ClinicalTrials.gov