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

Last updated: October 31, 2024
Sponsor: Acesion Pharma
Overall Status: Active - Recruiting

Phase

1

Condition

Healthy Volunteers

Treatment

Placebo

AP31969

Clinical Study ID

NCT06066099
AP31969-M101
2023-505424-57-00
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age : 18 years to 55 years, inclusive, at screening.

  2. Weight: ≥50 kg, at screening.

  3. Body mass index: 18.0 kg/m^2 to 30.0 kg/m^2, inclusive, at screening.

  4. Sex : male or female; female participants may be of childbearing potential or ofnonchildbearing potential (either surgically sterilized, physiologically incapableof becoming pregnant, or at least 1 year postmenopausal [amenorrhea duration of 12consecutive months] and confirmed by a follicle-stimulating hormone test atscreening).

  5. In good physical and mental health on the basis of medical history, physicalexamination, clinical laboratory, 12-lead electrocardiogram (ECG), and vital signs,as judged by the Investigator.

  6. 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 judgmentof the Investigator there is a reason to believe the initial result is inaccurate (eg, white coat hypertension).

  7. Computerized (12-lead) ECG recording without signs of clinically relevant pathologyand with a QT-interval with Fridericia's correction (QTcF-interval) interval between 300 and 450 ms, inclusive, at screening and (each) admission.

  8. Female participants must not be pregnant or lactating. Nonpregnancy will beconfirmed for all female participants by a negative serum pregnancy test atscreening and (each) admission.

  9. Female participants of childbearing potential who have a fertile male sexual partnermust agree to use highly effective contraception and not donate ova from 4 weeksprior to (the first) study drug administration until 90 days after the follow-upvisit.

  10. Male participants, if not surgically sterilized, who have a female sexual partner ofchildbearing potential must agree to use highly effective contraception and notdonate sperm from (first) admission until 90 days after the follow-up visit.

  11. Able to swallow up to 9 tablets of study drug (based on participant's own judgmentafter being informed about the possible number of tablets and the size of thetablets).

  12. Willing and able to understand and comply with the protocol requirements,restrictions, and instructions listed in the informed consent form (ICF) and in theprotocol and likely to complete the study as planned.

  13. Willing and able to sign the ICF.

Exclusion

Exclusion Criteria:

  1. Previous participation in the current study.

  2. Employee of ICON or the Sponsor.

  3. History of relevant drug and/or food allergies.

  4. History of any illness or condition that, in the opinion of the Investigator, mightconfound the results of the study or pose an additional risk when administering thestudy 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).

  5. History of any major disorder capable of significantly altering the absorption,metabolism, or elimination of the study drug, constituting a risk when taking thestudy drug, or interfering with the interpretation of data in the opinion of theInvestigator.

  6. Personal or first-degree relative family history of congenital long QT syndrome orsudden death.

  7. Presence of any signs of tremor in rest at screening or (at one of the) admission(s)to the clinical research center.

  8. Use of any prescribed medication within 30 days prior to (first) admission, based onInvestigator's judgment. An exception is made for hormonal contraceptives, which maybe used throughout the study.

  9. Use of any over-the-counter medication, vitamin preparations and other foodsupplements, or herbal medications (eg, St. John's wort) within 14 days prior to (first) admission, based on Investigator's judgment. An exception is made foracetaminophen/paracetamol, which is allowed up to 2 g/day.

  10. Positive screen for hepatitis B surface antigen, hepatitis C virus antibodies, orhuman immunodeficiency virus 1 and 2 antibodies, at screening. In case ofvaccination against these diseases, inclusion is allowed.

  11. Positive drug and alcohol screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclicantidepressants, and alcohol) at screening or (at one of the) admission(s) to theclinical research center.

  12. Average intake of more than 24 units of alcohol per week (1 unit of alcohol equalsapproximately 250 mL of beer, 100 mL of wine, or 35 mL of spirits).

  13. History of alcohol abuse or drug addiction (including soft drugs like cannabisproducts) within 2 years prior to screening.

  14. Smoking on average more than 5 cigarettes, 1 cigar, or 1 pipe daily.

  15. Participation in another drug study within 30 days prior to (the first) study drugadministration in the current study, or in 4 or more drug studies within 12 monthsprior to (the first) study drug administration in the current study.

  16. Donation or loss of more than 450 mL of blood within 60 days prior to (the first)study drug administration.

  17. Significant and/or acute illness within 5 days prior to (the first) study drugadministration that may impact safety assessments, in the opinion of theInvestigator.

  18. Unsuitable veins for blood sampling.

  19. For the food effect group only: unwilling to consume high-fat, high-calorie meal.

Study Design

Total Participants: 124
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
October 04, 2023
Estimated Completion Date:
February 27, 2025

Connect with a study center

  • Acesion Pharma

    Copenhagen, 2200
    Denmark

    Site Not Available

  • Acesion Pharma Investigational Site 10

    Groningen, 9728
    Netherlands

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.