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

NCT06232109 | Completed Phase 1

• 1 other identifier: ASN51-104
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug Drug Interaction

Outcome Measures

Primary Outcomes (6)

• Cmax of ASN51

  Up to Day 15

• Tmax of ASN51

  Up to Day 15

• 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

Secondary Outcomes (1)

• Number of participants with adverse events

  Up to Day 22

Study Arms (4)

ASN51

NO INTERVENTION

ASN51 + Fluvoxamine

EXPERIMENTAL

Drug: Fluvoxamine; Drug: ASN51

ASN51 + Itraconazole

EXPERIMENTAL

Drug: Itraconazole; Drug: ASN51

ASN51 + Paroxetine

EXPERIMENTAL

Drug: Paroxetine; Drug: ASN51

Interventions

Fluvoxamine DRUG

Oral

ASN51 + Fluvoxamine

Itraconazole DRUG

Oral

ASN51 + Itraconazole

Paroxetine DRUG

Oral

ASN51 + Paroxetine

ASN51 DRUG

Oral

ASN51 + Fluvoxamine; ASN51 + Itraconazole; ASN51 + Paroxetine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Asceneuron S.A.: lead

Study Sites (1)

ICON Groningen Van Swietenlaan 6

Groningen, 9728 NZ, Netherlands

Location

MeSH Terms

Interventions

Fluvoxamine; Itraconazole; Paroxetine

Intervention Hierarchy (Ancestors)

Oximes; Hydroxylamines; Amines; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Piperidines

Study Officials

• Rolf Pokorny, MD

  Asceneuron, SA

  STUDY CHAIR

• Jeroen v Wetering, MD

  QPS Holdings LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 30, 2024
• Study Start: February 22, 2024
• Primary Completion: July 3, 2024
• Study Completion: July 3, 2024
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)