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

Phase 1, Open-Label, Parallel Group Drug-Drug Interaction Study to Assess the Effect of Fluvoxamine (CYP2C19 Inhibitor), Itraconazole (CYP3A4 Inhibitor) and Paroxetine (CYP2D6 Inhibitor) on the Pharmacokinetics of ASN51 in Healthy Subjects

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

Study Overview

• Status: Recruiting
• Conditions: Drug Drug Interaction
• Intervention / Treatment: Drug: Itraconazole; Drug: Paroxetine; Drug: Fluvoxamine; Drug: ASN51

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Rolf Pokorny, MD; Phone Number: +41 21 353 8245; Email: rolf.pokorny@asceneuron.com

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728 NZ
    • Recruiting
    • ICON Groningen Van Swietenlaan 6
    • Contact: Stefab Slagter; Phone Number: +31 (0) 800-0292044; Email: Stefan.Slagter@iconplc.com
    • Principal Investigator: Jeroen v Wetering, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: ASN51
Experimental: ASN51 + Fluvoxamine	Drug: Fluvoxamine; Oral; Drug: ASN51; Oral
Experimental: ASN51 + Itraconazole	Drug: Itraconazole; Oral; Drug: ASN51; Oral
Experimental: ASN51 + Paroxetine	Drug: Paroxetine; Oral; Drug: ASN51; Oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events	Up to Day 22

Collaborators and Investigators

• Sponsor: Asceneuron S.A.
• Investigators: Study Chair: Rolf Pokorny, MD, Asceneuron, SA; Principal Investigator: Jeroen v Wetering, MD, QPS Holdings LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2024
• Primary Completion (Estimated): May 13, 2024
• Study Completion (Estimated): May 13, 2024

Study Registration Dates

• First Submitted: January 22, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Central Nervous System Depressants; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Tranquilizing Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Anti-Anxiety Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Hormone Antagonists; Antifungal Agents; Steroid Synthesis Inhibitors; 14-alpha Demethylase Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C19 Inhibitors; Selective Serotonin Reuptake Inhibitors; Paroxetine; Itraconazole; Fluvoxamine
• Other Study ID Numbers: ASN51-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No