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

Phase 1

Completed

• Conditions: Drug Drug Interaction
• Interventions: Drug: Paroxetine; Drug: Fluvoxamine; Drug: Itraconazole; Drug: ASN51

• Registration Number: NCT06232109
• Lead Sponsor: Asceneuron S.A.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-22
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-30
• Study Start: 2024-02-22
• Primary Completion: 2024-07-03
• Study Completion: 2024-07-03
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASN51 + Itraconazole	ASN51	-
ASN51 + Paroxetine	Paroxetine	-
ASN51 + Paroxetine	ASN51	-
ASN51 + Fluvoxamine	Fluvoxamine	-
ASN51 + Fluvoxamine	ASN51	-
ASN51 + Itraconazole	Itraconazole	-

Primary Outcome Measures

Name	Time	Method
AUC0-tau of ASN51	Up to Day 15
AUC0-inf of ASN51	Up to Day 15
t1/2 of ASN51	Up to Day 15
λz of ASN51	Up to Day 15
Cmax of ASN51	Up to Day 15
Tmax of ASN51	Up to Day 15

Secondary Outcome Measures

Name	Time	Method
Number of participants with adverse events	Up to Day 22

Trial Locations

Locations (1)

ICON Groningen Van Swietenlaan 6; 🇳🇱 Groningen, Netherlands