Phase
Condition
N/ATreatment
Fluvoxamine
Itraconazole
Paroxetine
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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) atScreening
Exclusion
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 studymedication, that could interfere with the objectives of the study or the safety ofthe subject
History or presence of acute or chronic illness, or clinically-significant medicalabnormality, sufficient to invalidate the subject's participation in the study ormake it unnecessarily hazardous
History or presence of any disease, medical condition, or surgery (e.g., stomachbypass), likely to affect the absorption, distribution, metabolism, or excretion ofmedicines. Subjects with a history of cholecystectomy
Presence or history of severe or clinically significant adverse reaction to anydrug; or a history of sensitivity to ASN51 (all subjects), or any components of themedications
Receipt of an investigational product or device within 6 weeks (or 5 half-lives, ortwice the duration of the biological effect, of the investigational product, ifknown - whichever is longer) before the first dose of study medication; in thefollow-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 dietarysupplements (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 enzymeinducer) 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 Design
Connect with a study center
ICON Groningen Van Swietenlaan 6
Groningen, 9728 NZ
NetherlandsSite Not Available
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