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

Last updated: December 16, 2024
Sponsor: Asceneuron S.A.
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

Fluvoxamine

Itraconazole

Paroxetine

Clinical Study ID

NCT06232109
ASN51-104
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The drug-drug interaction study has been designed to investigate the effect of Fluvoxamine, Itraconazole and Paroxetine on the pharmacokinetics of ASN51

Eligibility Criteria

Inclusion

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) atScreening

Exclusion

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 studymedication, that could interfere with the objectives of the study or the safety ofthe subject

  • History or presence of acute or chronic illness, or clinically-significant medicalabnormality, sufficient to invalidate the subject's participation in the study ormake it unnecessarily hazardous

  • History or presence of any disease, medical condition, or surgery (e.g., stomachbypass), likely to affect the absorption, distribution, metabolism, or excretion ofmedicines. Subjects with a history of cholecystectomy

  • Presence or history of severe or clinically significant adverse reaction to anydrug; or a history of sensitivity to ASN51 (all subjects), or any components of themedications

  • Receipt of an investigational product or device within 6 weeks (or 5 half-lives, ortwice the duration of the biological effect, of the investigational product, ifknown - whichever is longer) before the first dose of study medication; in thefollow-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 dietarysupplements (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 enzymeinducer) 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

Study Design

Total Participants: 50
Treatment Group(s): 4
Primary Treatment: Fluvoxamine
Phase: 1
Study Start date:
February 22, 2024
Estimated Completion Date:
July 03, 2024

Connect with a study center

  • ICON Groningen Van Swietenlaan 6

    Groningen, 9728 NZ
    Netherlands

    Site Not Available

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