A Phase 1 interventional study of AP31969 and Placebo in Healthy Volunteers, sponsored by Acesion Pharma. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-14.
Sponsored by Acesion Pharma · Phase 1, Interventional, and Basic science
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.
Exclusion Criteria:
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).
Drug: AP31969 · Drug: Placebo
Participants will be randomized to receive multiple oral doses of AP31969 or matching placebo for 10 days in 1 of 4 groups.
Drug: AP31969 · Drug: Placebo
Oral tablets
Oral tablets
Number of Participants who Experienced an Adverse Event
Time frame: Up to a maximum of 48 days
Parts A and B: Maximum Observed Plasma Concentration (Cmax) of AP31969
Time frame: Part A: Day 1 to Day 4; Part B: Day 1 to Day 12
Parts A and B: Time to Cmax (tmax) of AP31969
Time frame: Part A: Day 1 to Day 4; Part B: Day 1 to Day 12
Parts A and B: Terminal Elimination Half-life of AP31969
Time frame: 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
Time frame: Part A: Day 1 to Day 4
Part A: AUC from Time 0 Extrapolated to Infinity (AUC0-inf) of AP31969
Time frame: Part A: Day 1 to Day 4
Part B: AUC Over a Dosing Interval Tau (AUCtau) of AP31969
Time frame: Part B: Day 1 to Day 10
Part A: Apparent Clearance of AP31969
Time frame: Part A: Day 1 to Day 4
Part B: Apparent Clearance at Steady State of AP31969
Time frame: Part B: Day 1 to Day 10
Parts A and B: Apparent Volume of Distribution at Terminal Phase of AP31969
Time frame: Part A: Day 1 to Day 4; Part B: Day 1 to Day 10
Part B: Accumulation Ratio of AP31969
Time frame: Part B: Day 1 to Day 10
Parts A and B: Dose Normalized Cmax of AP31969
Time frame: Part A: Day 1 to Day 4; Part B: Day 1 to Day 10
Part A: Dose Normalized AUC0-last of AP31969
Time frame: Part A: Day 1 to Day 4
Part A: Dose Normalized AUC0-inf of AP31969
Time frame: Part A: Day 1 to Day 4
Part B: Dose Normalized AUCtau of AP31969
Time frame: Part B: Day 1 to Day 10
Part A: Food Effect on Cmax of AP31969
Time frame: 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
Time frame: 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
Time frame: Part A: Day 1 to Day 4 of fed and fasted treatment periods of the food effect assessment group
Plan to share: No
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Acesion Pharma