Drug Drug Interaction
Conditions
Brief summary
The drug-drug interaction study has been designed to investigate the effect of Fluvoxamine, Itraconazole and Paroxetine on the pharmacokinetics of ASN51
Interventions
Sponsors
Asceneuron S.A.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AUC0-tau of ASN51 | Up to Day 15 |
| Cmax of ASN51 | Up to Day 15 |
| Tmax of ASN51 | Up to Day 15 |
| λz of ASN51 | Up to Day 15 |
| AUC0-inf of ASN51 | Up to Day 15 |
| t1/2 of ASN51 | Up to Day 15 |
Secondary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | Up to Day 22 |
Countries
Netherlands
Outcome results
None listed