Search / Trial NCT06232109

Drug-Drug Interaction of ASN51 With Fluvoxamine, Itraconazole and Paroxetine in Healthy Subjects

Launched by ASCENEURON S.A. · Jan 22, 2024

Trial Information

Current as of December 22, 2024

Completed

Keywords

ClinConnect Summary

This clinical trial is studying how three different medications—Fluvoxamine, Itraconazole, and Paroxetine—affect the way the body processes a new drug called ASN51. The goal is to understand if these medications interact with ASN51, which is important to ensure safety and effectiveness for future patients. This study is currently looking for healthy volunteers aged 18 to 55 who meet specific health criteria, such as having a normal medical history and passing various health tests.

Participants in this trial can expect to undergo health screenings to confirm their eligibility, and if selected, they will receive the study medication under close medical supervision. It’s important to note that individuals with certain health conditions or who have taken specific medications recently may not qualify for the study. Overall, this trial aims to gather valuable information to help improve how ASN51 is used in the future.

Gender

ALL

Eligibility criteria

  • Key Inclusion Criteria:
  • Healthy males or females of nonchildbearing potential
  • Aged 18-55 years (inclusive) at time of Screening
  • Deemed healthy based on medical history, physical and neurological examination, electrocardiogram (ECG), vital signs, and laboratory tests of blood and urine
  • Body weight ≥ 50.0 kg (men) or ≥ 45.0 kg (women) at Screening
  • Body mass index (BMI); Quetelet index in the range 18.0-30.9 kg/m2 (inclusive) at Screening
  • Key Exclusion Criteria:
  • Clinically relevant abnormal medical history, physical or neurological findings, ECG, or laboratory values at Screening, or before the first dose of any study medication, that could interfere with the objectives of the study or the safety of the subject
  • History or presence of acute or chronic illness, or clinically-significant medical abnormality, sufficient to invalidate the subject's participation in the study or make it unnecessarily hazardous
  • History or presence of any disease, medical condition, or surgery (e.g., stomach bypass), likely to affect the absorption, distribution, metabolism, or excretion of medicines. Subjects with a history of cholecystectomy
  • Presence or history of severe or clinically significant adverse reaction to any drug; or a history of sensitivity to ASN51 (all subjects), or any components of the medications
  • Receipt of an investigational product or device within 6 weeks (or 5 half-lives, or twice the duration of the biological effect, of the investigational product, if known - whichever is longer) before the first dose of study medication; in the follow-up period of another clinical study at the time of Screening for this study
  • Use of a prescription medicine during the 14 days (or 5 half-lives of the medicine, if known - whichever is longer) before the first dose of study medication
  • Use of an over-the-counter medicine, including vitamins, herbal, or dietary supplements (including St John's Wort), with the exception of acetaminophen (paracetamol), during the 7 days (or 5 half-lives of the medicine, if known - whichever is longer, or 28 days if the medicine is a potential hepatic enzyme inducer) before the first dose of study medication
  • Positive test for hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply

Trial Officials

Rolf Pokorny, MD

Study Chair

Asceneuron, SA

Jeroen v Wetering, MD

Principal Investigator

QPS Holdings LLC

About Asceneuron S.A.

Asceneuron S.A. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for neurodegenerative diseases, with a commitment to addressing unmet medical needs in conditions such as Alzheimer's disease and other age-related cognitive disorders. Leveraging advanced drug discovery platforms and a robust pipeline of novel therapeutics, Asceneuron aims to enhance the quality of life for patients through targeted interventions that modify disease progression. The company's dedication to scientific excellence and collaboration with leading research institutions positions it as a key player in the field of neurodegeneration, striving to bring meaningful solutions to patients and healthcare providers.

Locations

Groningen, , Netherlands

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0