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Healthy VolunteersPhase 1NCT06066099

Single Ascending Dose, Multiple Ascending Dose, Food Effect Study With AP31969

A Phase 1 study testing AP31969 in people with Healthy Volunteers, run by Acesion Pharma at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
AP31969
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
92 participants
Where
1 siteNetherlands
Study dates
4 Oct 2023to 14 Mar 2025
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
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age : 18 years to 55 years, inclusive, at screening.
  • Weight: ≥50 kg, at screening.
  • Body mass index: 18.0 kg/m^2 to 30.0 kg/m^2, inclusive, at screening.
  • Sex : male or female; female participants may be of childbearing potential or of nonchildbearing potential (either surgically sterilized, physiologically incapable of becoming pregnant, or at least 1 year postmenopausal [amenorrhea duration of 12 consecutive months] and confirmed by a follicle-stimulating hormone test at screening).
  • In good physical and mental health on the basis of medical history, physical examination, clinical laboratory, 12-lead electrocardiogram (ECG), and vital signs, as judged by the Investigator.
  • Resting supine systolic blood pressure (BP) (average of 3 readings) between 140 and 90 mmHg (inclusive, at screening and [each] admission), and diastolic BP (average of 3 readings) between 90 and 50 mmHg (inclusive, at screening and [each] admission). If initial results do not meet these criteria, BP may be repeated if in the judgment of the Investigator there is a reason to believe the initial result is inaccurate (eg, white coat hypertension).
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  • Computerized (12-lead) ECG recording without signs of clinically relevant pathology and with a QT-interval with Fridericia's correction (QTcF-interval) interval between 300 and 450 ms, inclusive, at screening and (each) admission.
  • Female participants must not be pregnant or lactating. Nonpregnancy will be confirmed for all female participants by a negative serum pregnancy test at screening and (each) admission.
  • Female participants of childbearing potential who have a fertile male sexual partner must agree to use highly effective contraception and not donate ova from 4 weeks prior to (the first) study drug administration until 90 days after the follow-up visit.
  • Male participants, if not surgically sterilized, who have a female sexual partner of childbearing potential must agree to use highly effective contraception and not donate sperm from (first) admission until 90 days after the follow-up visit.
  • Able to swallow up to 9 tablets of study drug (based on participant's own judgment after being informed about the possible number of tablets and the size of the tablets).
  • Willing and able to understand and comply with the protocol requirements, restrictions, and instructions listed in the informed consent form (ICF) and in the protocol and likely to complete the study as planned.
  • Willing and able to sign the ICF.

Who cannot join

  • Previous participation in the current study.
  • Employee of ICON or the Sponsor.
  • History of relevant drug and/or food allergies.
  • History of any illness or condition that, in the opinion of the Investigator, might confound the results of the study or pose an additional risk when administering the study drug to the subject (with particular focus on cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, cerebrovascular, and neurological diseases including history of syncope and/or convulsions).
  • History of any major disorder capable of significantly altering the absorption, metabolism, or elimination of the study drug, constituting a risk when taking the study drug, or interfering with the interpretation of data in the opinion of the Investigator.
  • Personal or first-degree relative family history of congenital long QT syndrome or sudden death.
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  • Presence of any signs of tremor in rest at screening or (at one of the) admission(s) to the clinical research center.
  • Use of any prescribed medication within 30 days prior to (first) admission, based on Investigator's judgment. An exception is made for hormonal contraceptives, which may be used throughout the study.
  • Use of any over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's wort) within 14 days prior to (first) admission, based on Investigator's judgment. An exception is made for acetaminophen/paracetamol, which is allowed up to 2 g/day.
  • Positive screen for hepatitis B surface antigen, hepatitis C virus antibodies, or human immunodeficiency virus 1 and 2 antibodies, at screening. In case of vaccination against these diseases, inclusion is allowed.
  • Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants, and alcohol) at screening or (at one of the) admission(s) to the clinical research center.
  • Average intake of more than 24 units of alcohol per week (1 unit of alcohol equals approximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).
  • History of alcohol abuse or drug addiction (including soft drugs like cannabis products) within 2 years prior to screening.
  • Smoking on average more than 5 cigarettes, 1 cigar, or 1 pipe daily.
  • Participation in another drug study within 30 days prior to (the first) study drug administration in the current study, or in 4 or more drug studies within 12 months prior to (the first) study drug administration in the current study.
  • Donation or loss of more than 450 mL of blood within 60 days prior to (the first) study drug administration.
  • Significant and/or acute illness within 5 days prior to (the first) study drug administration that may impact safety assessments, in the opinion of the Investigator.
  • Unsuitable veins for blood sampling.
  • For the food effect group only: unwilling to consume high-fat, high-calorie meal.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Acesion Pharma Investigational Site 10

    Groningen, 9728

Other trials in Netherlands

About this study

Official title: A Controlled, Randomized, First-In-Human Study of AP31969 Investigating Single and Multiple Ascending Doses and the Effect of Food in Healthy Subjects

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.

Being tested
AP31969, Placebo
Keywords
Antiarrhythmic agent, Cardiac arrhythmia, Atrial Fibrillation
Medical subject headings
Arrhythmias, Cardiac, Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AP31969Drug

    Oral tablets

  • PlaceboDrug

    Oral tablets

Study groups in NCT06066099
Study groupRoleWhat they receive
Part A: Single Ascending DosesExperimentalParticipants 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).
Receives: Drug: AP31969; Drug: Placebo
Part B: Multiple Ascending DosesExperimentalParticipants will be randomized to receive multiple oral doses of AP31969 or matching placebo for 10 days in 1 of 4 groups.
Receives: Drug: AP31969; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants who Experienced an Adverse Event

    Measured: Up to a maximum of 48 days

Secondary outcomes (17)

  1. Parts A and B: Maximum Observed Plasma Concentration (Cmax) of AP31969

    Measured: Part A: Day 1 to Day 4; Part B: Day 1 to Day 12

  2. Parts A and B: Time to Cmax (tmax) of AP31969

    Measured: Part A: Day 1 to Day 4; Part B: Day 1 to Day 12

  3. Parts A and B: Terminal Elimination Half-life of AP31969

    Measured: Part A: Day 1 to Day 4; Part B: Day 1 to Day 12

  4. Part A: Area Under the Plasma Concentration Time Curve (AUC) from Time 0 to Time of Last Quantifiable Concentration (AUC0-last) of AP31969

    Measured: Part A: Day 1 to Day 4

  5. Part A: AUC from Time 0 Extrapolated to Infinity (AUC0-inf) of AP31969

    Measured: Part A: Day 1 to Day 4

  6. Part B: AUC Over a Dosing Interval Tau (AUCtau) of AP31969

    Measured: Part B: Day 1 to Day 10

  7. Part A: Apparent Clearance of AP31969

    Measured: Part A: Day 1 to Day 4

  8. Part B: Apparent Clearance at Steady State of AP31969

    Measured: Part B: Day 1 to Day 10

  9. Parts A and B: Apparent Volume of Distribution at Terminal Phase of AP31969

    Measured: Part A: Day 1 to Day 4; Part B: Day 1 to Day 10

  10. Part B: Accumulation Ratio of AP31969

    Measured: Part B: Day 1 to Day 10

  11. Parts A and B: Dose Normalized Cmax of AP31969

    Measured: Part A: Day 1 to Day 4; Part B: Day 1 to Day 10

  12. Part A: Dose Normalized AUC0-last of AP31969

    Measured: Part A: Day 1 to Day 4

  13. Part A: Dose Normalized AUC0-inf of AP31969

    Measured: Part A: Day 1 to Day 4

  14. Part B: Dose Normalized AUCtau of AP31969

    Measured: Part B: Day 1 to Day 10

  15. Part A: Food Effect on Cmax of AP31969

    Measured: Part A: Day 1 to Day 4 of fed and fasted treatment periods of the food effect assessment group

  16. Part A: Food Effect on AUC0-last of AP31969

    Measured: Part A: Day 1 to Day 4 of fed and fasted treatment periods of the food effect assessment group

  17. Part A: Food Effect on AUC0-inf of AP31969

    Measured: Part A: Day 1 to Day 4 of fed and fasted treatment periods of the food effect assessment group

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2023
  2. Study start4 Oct 2023
  3. Primary completion14 Mar 2025
  4. Study completion14 Mar 2025

Resources

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
Basic science
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06066099
Sponsor's protocol ID
AP31969-M101
Other IDs
2023-505424-57-00, 2023
Status last verified
Jul 2025
First submitted
27 Sep 2023
Last updated
14 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AP31969 in people with Healthy Volunteers, run by Acesion Pharma at 1 site in Netherlands.

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 13 inclusion and 19 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 14 Jul 2025. 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 Netherlands. 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. 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 who Experienced an Adverse Event (time frame: Up to a maximum of 48 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06066099.

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 14 Jul 2025.

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