Status:
COMPLETED
3-part Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EXS21546
Lead Sponsor:
Exscientia AI Limited
Collaborating Sponsors:
Quotient Sciences
Conditions:
Oncology
Eligibility:
MALE
18-55 years
Phase:
PHASE1
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 ...
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 explor...
Eligibility Criteria
Inclusion
- BMI 18.0 to 30.0 kg/m2
- Weight ≥60 kg
- Must adhere to contraception requirements
Exclusion
- 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
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2022
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04727138
Start Date
December 8 2020
End Date
May 12 2022
Last Update
May 16 2022
Active Locations (1)
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1
Quotient Sciences
Nottingham, United Kingdom, NG11 6JS