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

Asceneuron

Status and phase: Enrolling; Phase 1

Conditions: Drug Drug Interaction

Treatments: Drug: ASN51; Drug: Paroxetine; Drug: Itraconazole; Drug: Fluvoxamine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06232109

ASN51-104

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 4 patient groups

ASN51

No Intervention group

ASN51 + Fluvoxamine

Experimental group

Treatment:

Drug: Fluvoxamine

Drug: ASN51

ASN51 + Itraconazole

Experimental group

Treatment:

Drug: Itraconazole

Drug: ASN51

ASN51 + Paroxetine

Experimental group

Treatment:

Drug: Paroxetine

Drug: ASN51