Clinical trial NCT06232109: Drug-Drug Interaction of ASN51 With Fluvoxamine, Itraconazole and Paroxetine in Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Drug Interaction
Lead sponsor: Asceneuron S.A.
Sponsor class: INDUSTRY
First posted: 2024-01-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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: 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

Primary outcomes:
measure: Cmax of ASN51
timeFrame: Up to Day 15
measure: Tmax of ASN51
timeFrame: Up to Day 15
measure: AUC0-tau of ASN51
timeFrame: Up to Day 15
measure: AUC0-inf of ASN51
timeFrame: Up to Day 15
measure: t1/2 of ASN51
timeFrame: Up to Day 15
measure: λz of ASN51
timeFrame: Up to Day 15
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Up to Day 22
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: ICON Groningen Van Swietenlaan 6
Study officials:
affiliation: Asceneuron, SA
name: Rolf Pokorny, MD
role: STUDY_CHAIR
affiliation: QPS Holdings LLC
name: Jeroen v Wetering, MD
role: PRINCIPAL_INVESTIGATOR
References: