OncologyPhase 1NCT04727138
3-part Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EXS21546
A Phase 1 study testing EXS21546 Powder for Oral Suspension, EXS21546 Granule in Capsule and Midazolam in people with Oncology, run by Exscientia AI Limited at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Oncology
- What is being tested?
- EXS21546 Powder for Oral Suspension, EXS21546 Granule in Capsule and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Dec 2020to 12 May 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18.0 to 30.0 kg/m2
- Weight ≥60 kg
- Must adhere to contraception requirements
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXS21546 Powder for Oral SuspensionDrug
EXS21546 Powder for Oral Suspension
EXS21546 Granule in CapsuleDrug
EXS21546 Granule in Capsule
MidazolamOther
Interaction
Food EffectOther
Fed/Fasted
Placebo Powder for Oral SuspensionOther
Placebo Powder for Oral Suspension
| Study group | Role | What they receive |
|---|---|---|
| EXS21546 Powder for Oral Suspension | Experimental | EXS21546 Powder for Oral Suspension Receives: Drug: EXS21546 Powder for Oral Suspension; Other: Midazolam; Other: Food Effect |
| Placebo | Placebo comparator | Placebo Powder for Oral Suspension Receives: Other: Midazolam; Other: Food Effect; Other: Placebo Powder for Oral Suspension |
| EXS21546 Granule in Capsule | Experimental | EXS21546 Granule in Capsule Receives: Drug: EXS21546 Granule in Capsule; Other: Food Effect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment emergent Adverse Events
Number of participants with treatment emergent Adverse Events
Measured: 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)
Measured: 17 days
EXS21546 and Metabolite Peak Plasma Concentration (Cmax)
EXS21546 and Metabolite Peak Plasma Concentration (Cmax)
Measured: 17 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start8 Dec 2020
- Primary completion16 Apr 2022
- Study completion12 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OncologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exscientia AI Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Responsible party
- Sponsor
- Investigators
- Phillip Evans, Principal investigator, Quotient Sciences Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727138
- Sponsor's protocol ID
- EXS21546-001
- Status last verified
- May 2022
- First submitted
- 23 Dec 2020
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04727138
- Acronym / sponsor ID
- EXS21546-001
- Conditions
- Oncology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Exscientia AI LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Sciences
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 16 Apr 2022 (actual)
- Study completion
- 12 May 2022 (actual)
- First posted
- 27 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| EXS21546 Powder for Oral Suspension | Experimental | Drug: EXS21546 Powder for Oral Suspension, Other: Midazolam, Other: Food EffectEXS21546 Powder for Oral Suspension |
| Placebo | Placebo comparator | Other: Midazolam, Other: Food Effect, Other: Placebo Powder for Oral SuspensionPlacebo Powder for Oral Suspension |
| EXS21546 Granule in Capsule | Experimental | Drug: EXS21546 Granule in Capsule, Other: Food EffectEXS21546 Granule in Capsule |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 18.0 to 30.0 kg/m2
- Weight ≥60 kg
- Must adhere to contraception requirements
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EXS21546 Powder for Oral SuspensionEXS21546 Powder for Oral Suspension | Drug | EXS21546 Powder for Oral Suspension |
| EXS21546 Granule in CapsuleEXS21546 Granule in Capsule | Drug | EXS21546 Granule in Capsule |
| MidazolamInteraction | Other | EXS21546 Powder for Oral Suspension, Placebo |
| Food EffectFed/Fasted | Other | EXS21546 Granule in Capsule, EXS21546 Powder for Oral Suspension, Placebo |
| Placebo Powder for Oral SuspensionPlacebo Powder for Oral Suspension | Other | Placebo |
Primary outcome
Number of participants with treatment emergent Adverse Events
Time frame: 1 month
Number of participants with treatment emergent Adverse Events
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)
EXS21546 and Metabolite Peak Plasma Concentration (Cmax)
Time frame: 17 days
EXS21546 and Metabolite Peak Plasma Concentration (Cmax)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phillip Evans principal investigator
Quotient Sciences Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EXS21546 Powder for Oral Suspension, EXS21546 Granule in Capsule and Midazolam in people with Oncology, run by Exscientia AI Limited at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment emergent Adverse Events (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2022.