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

Drug Drug Interaction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06232109
• Other study ID #: ASN51-104
• Status: Recruiting
• Phase: Phase 1
• Start date: February 22, 2024
• Est. completion date: May 13, 2024

Study information

• Verified date: April 2024
• Source: Asceneuron S.A.
• Contact: Rolf Pokorny, MD
• Phone: +41 21 353 8245
• Email: rolf.pokorny[@]asceneuron.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: May 13, 2024
• Est. primary completion date: May 13, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Drug Interaction

Intervention

Drug:
• Fluvoxamine
Oral
• Itraconazole
Oral
• Paroxetine
Oral
• ASN51
Oral

Locations

Country	Name	City	State
Netherlands	ICON Groningen Van Swietenlaan 6	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Asceneuron S.A.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of ASN51		Up to Day 15
Primary	Tmax of ASN51		Up to Day 15
Primary	AUC0-tau of ASN51		Up to Day 15
Primary	AUC0-inf of ASN51		Up to Day 15
Primary	t1/2 of ASN51		Up to Day 15
Primary	?z of ASN51		Up to Day 15
Secondary	Number of participants with adverse events		Up to Day 22