Clinical trial · Interventional
3-part Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EXS21546
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
NCT04727138CI-TRIAL-00058506completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EXS21546 Granule in Capsule | Drug | — | UNRESOLVED |
| EXS21546 Powder for Oral Suspension | Drug | — | UNRESOLVED |
| Food Effect | Other | — | UNRESOLVED |
| Midazolam | Other | — | UNRESOLVED |
| Placebo Powder for Oral Suspension | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- EXS21546 Powder for Oral Suspension
- description
- EXS21546 Powder for Oral Suspension
- interventionNames
- Drug: EXS21546 Powder for Oral Suspension
- Other: Midazolam
- Other: Food Effect
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo Powder for Oral Suspension
- interventionNames
- Other: Midazolam
- Other: Food Effect
- Other: Placebo Powder for Oral Suspension
- type
- EXPERIMENTAL
- label
- EXS21546 Granule in Capsule
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.