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

NCT ID: NCT06232109

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-22

Study Completion Date

2024-07-03

Brief Summary

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

Detailed Description

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Conditions

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Drug Drug Interaction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ASN51

Group Type NO_INTERVENTION

No interventions assigned to this group

ASN51 + Fluvoxamine

Group Type EXPERIMENTAL

Fluvoxamine

Intervention Type DRUG

Oral

ASN51

Intervention Type DRUG

Oral

ASN51 + Itraconazole

Group Type EXPERIMENTAL

Itraconazole

Intervention Type DRUG

Oral

ASN51

Intervention Type DRUG

Oral

ASN51 + Paroxetine

Group Type EXPERIMENTAL

Paroxetine

Intervention Type DRUG

Oral

ASN51

Intervention Type DRUG

Oral

Interventions

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Fluvoxamine

Oral

Intervention Type DRUG

Itraconazole

Oral

Intervention Type DRUG

Paroxetine

Oral

Intervention Type DRUG

ASN51

Oral

Intervention Type DRUG

Eligibility Criteria

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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

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Asceneuron S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rolf Pokorny, MD

Role: STUDY_CHAIR

Asceneuron, SA

Jeroen v Wetering, MD

Role: PRINCIPAL_INVESTIGATOR

QPS Holdings LLC

Locations

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ICON Groningen Van Swietenlaan 6

Groningen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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ASN51-104

Identifier Type: -

Identifier Source: org_study_id