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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-505424-57-00 | Other Identifier | EU CT Number |
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The primary objective of the study is to evaluate the safety and tolerability of single doses (Part A) and multiple doses (Part B) of AP31969 in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Single Ascending Doses | Experimental | Participants will be randomized to receive a single oral dose of AP31969 or matching placebo in 1 of 5 groups. Participants in an additional food effect assessment group will be randomized to receive 2 single oral doses of AP31969 or matching placebo; 1 dose in fasted and 1 dose in fed state in a 2-period, fixed-sequence design (first fasted, then fed with at least 1 week washout between periods). |
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| Part B: Multiple Ascending Doses | Experimental | Participants will be randomized to receive multiple oral doses of AP31969 or matching placebo for 10 days in 1 of 4 groups. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AP31969 | Drug | Oral tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants who Experienced an Adverse Event | Up to a maximum of 48 days |
| Measure | Description | Time Frame |
|---|---|---|
| Parts A and B: Maximum Observed Plasma Concentration (Cmax) of AP31969 | Part A: Day 1 to Day 4; Part B: Day 1 to Day 12 | |
| Parts A and B: Time to Cmax (tmax) of AP31969 | Part A: Day 1 to Day 4; Part B: Day 1 to Day 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Director Clinical Operations | Acesion Pharma | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Acesion Pharma Investigational Site 10 | Groningen | 9728 | Netherlands |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Drug | Oral tablets |
|
| Parts A and B: Terminal Elimination Half-life of AP31969 | Part A: Day 1 to Day 4; Part B: Day 1 to Day 12 |
| Part A: Area Under the Plasma Concentration Time Curve (AUC) from Time 0 to Time of Last Quantifiable Concentration (AUC0-last) of AP31969 | Part A: Day 1 to Day 4 |
| Part A: AUC from Time 0 Extrapolated to Infinity (AUC0-inf) of AP31969 | Part A: Day 1 to Day 4 |
| Part B: AUC Over a Dosing Interval Tau (AUCtau) of AP31969 | Part B: Day 1 to Day 10 |
| Part A: Apparent Clearance of AP31969 | Part A: Day 1 to Day 4 |
| Part B: Apparent Clearance at Steady State of AP31969 | Part B: Day 1 to Day 10 |
| Parts A and B: Apparent Volume of Distribution at Terminal Phase of AP31969 | Part A: Day 1 to Day 4; Part B: Day 1 to Day 10 |
| Part B: Accumulation Ratio of AP31969 | Part B: Day 1 to Day 10 |
| Parts A and B: Dose Normalized Cmax of AP31969 | Part A: Day 1 to Day 4; Part B: Day 1 to Day 10 |
| Part A: Dose Normalized AUC0-last of AP31969 | Part A: Day 1 to Day 4 |
| Part A: Dose Normalized AUC0-inf of AP31969 | Part A: Day 1 to Day 4 |
| Part B: Dose Normalized AUCtau of AP31969 | Part B: Day 1 to Day 10 |
| Part A: Food Effect on Cmax of AP31969 | Part A: Day 1 to Day 4 of fed and fasted treatment periods of the food effect assessment group |
| Part A: Food Effect on AUC0-last of AP31969 | Part A: Day 1 to Day 4 of fed and fasted treatment periods of the food effect assessment group |
| Part A: Food Effect on AUC0-inf of AP31969 | Part A: Day 1 to Day 4 of fed and fasted treatment periods of the food effect assessment group |