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

NCT04727138 | Completed Phase 1

• 1 other identifier: EXS21546-001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Oncology

Outcome Measures

Primary Outcomes (3)

• Number of participants with treatment emergent Adverse Events

  Number of participants with treatment emergent Adverse Events

  1 month

• 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

• EXS21546 and Metabolite Peak Plasma Concentration (Cmax)

  EXS21546 and Metabolite Peak Plasma Concentration (Cmax)

  17 days

Study Arms (3)

EXS21546 Powder for Oral Suspension

EXPERIMENTAL

EXS21546 Powder for Oral Suspension

Drug: EXS21546 Powder for Oral Suspension; Other: Midazolam; Other: Food Effect

Placebo

PLACEBO COMPARATOR

Placebo Powder for Oral Suspension

Other: Midazolam; Other: Food Effect; Other: Placebo Powder for Oral Suspension

EXS21546 Granule in Capsule

EXPERIMENTAL

EXS21546 Granule in Capsule

Drug: EXS21546 Granule in Capsule; Other: Food Effect

Interventions

EXS21546 Powder for Oral Suspension DRUG

EXS21546 Powder for Oral Suspension

EXS21546 Powder for Oral Suspension

EXS21546 Granule in Capsule DRUG

EXS21546 Granule in Capsule

EXS21546 Granule in Capsule

Midazolam OTHER

Interaction

EXS21546 Powder for Oral Suspension; Placebo

Food Effect OTHER

Fed/Fasted

EXS21546 Granule in Capsule; EXS21546 Powder for Oral Suspension; Placebo

Placebo Powder for Oral Suspension OTHER

Placebo Powder for Oral Suspension

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 18.0 to 30.0 kg/m2
• Weight ≥60 kg
• Must adhere to contraception requirements

You may not qualify if:

• 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

Sponsors & Collaborators

• Exscientia AI Limited: lead
• Quotient Sciences: collaborator

Study Sites (1)

Quotient Sciences

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Suspensions; Capsules; Midazolam

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Phillip Evans

  Quotient Sciences Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Part 1 and Part 2 are double blind. Part 3 is open label.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: January 27, 2021
• Study Start: December 8, 2020
• Primary Completion: April 16, 2022
• Study Completion: May 12, 2022
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)