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

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ClinicalTrials.gov Identifier: NCT04727138
Recruitment Status : Recruiting
First Posted : January 27, 2021
Last Update Posted : January 29, 2021
Sponsor:
Collaborator:
Quotient Sciences
Information provided by (Responsible Party):
Exscientia Limited

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.

Condition or disease Intervention/treatment Phase
Oncology Drug: EXS21546 Powder for Oral Suspension Drug: EXS21546 Granule in Capsule Other: Midazolam Other: Food Effect Other: Placebo Powder for Oral Suspension Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Part 1 and Part 2 are double blind. Part 3 is open label.
Primary Purpose: Treatment
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
Actual Study Start Date : December 8, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: EXS21546 Powder for Oral Suspension
EXS21546 Powder for Oral Suspension
Drug: EXS21546 Powder for Oral Suspension
EXS21546 Powder for Oral Suspension

Other: Midazolam
Interaction

Other: Food Effect
Fed/Fasted

Placebo Comparator: Placebo
Placebo Powder for Oral Suspension
Other: Midazolam
Interaction

Other: Food Effect
Fed/Fasted

Other: Placebo Powder for Oral Suspension
Placebo Powder for Oral Suspension

Experimental: EXS21546 Granule in Capsule
EXS21546 Granule in Capsule
Drug: EXS21546 Granule in Capsule
EXS21546 Granule in Capsule

Other: Food Effect
Fed/Fasted




Primary Outcome Measures :
  1. Number of participants with treatment emergent Adverse Events [ Time Frame: 1 month ]
    Number of participants with treatment emergent Adverse Events

  2. EXS21546 and Metabolite Area under the plasma concentration versus time curve (AUC) [ Time Frame: 17 days ]
    EXS21546 and Metabolite Area under the plasma concentration versus time curve (AUC)

  3. EXS21546 and Metabolite Peak Plasma Concentration (Cmax) [ Time Frame: 17 days ]
    EXS21546 and Metabolite Peak Plasma Concentration (Cmax)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04727138


Contacts
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Contact: Holly Garratt 01865 818941 hgarratt@exscientia.co.uk

Locations
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United Kingdom
Quotient Sciences Recruiting
Nottingham, United Kingdom, NG11 6JS
Contact: Phillip Evans    0330 330 0000    volunteer@quotientsciences.com   
Contact: Michelle Lawton    0115 974 9000    Michelle.Lawton@quotientsciences.com   
Principal Investigator: Phillip Evans         
Sponsors and Collaborators
Exscientia Limited
Quotient Sciences
Investigators
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Principal Investigator: Phillip Evans Quotient Sciences Principal Investigator
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Responsible Party: Exscientia Limited
ClinicalTrials.gov Identifier: NCT04727138    
Other Study ID Numbers: EXS21546-001
First Posted: January 27, 2021    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action