An open*label, randomized, 3*period crossover study to determine the relative bioavailability of ASN120290 from a film*coated tablet given under fasted and fed conditions as compared to a capsule given under fasted conditions in healthy subjects

Completed

• Conditions: eurodegenerative disorder; PSP; Steele-Richardson-Olszweski syndrome

• Registration Number: NL-OMON48189
• Lead Sponsor: Asceneuron SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2019-12-09
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

Inclusion Criteria

Deemed healthy on the basis of medical history, physical examination, ECG, vital signs, and laboratory tests of blood and urine. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if, in the opinion of the Investigator, the finding is (a) unlikely to introduce additional risk to the subject, (b) will not interfere with study procedures or confound study results and (c) is not evaluated as clinically significant.;Subjects must be between 18 and 75 years of age, inclusive, at Screening.;Male healthy volunteer, or women of non*childbearing potential (i.e. postmenopausal [the last spontaneous menstrual period was at least 12 months ago, and FSH at Screening confirms post*menopausal status (FSH *30 U/L)], or has no uterus, ovaries or fallopian tubes or has their fallopian tubes tied).;For more inclusion criteria please refer to the protocol.

Exclusion Criteria

Women who are pregnant, or lactating, or of child-bearing potential.;History of epilepsy or seizures, other than benign febrile convulsions in childhood.;Positive result for suicidal ideation or behavior using the C*SSRS at Screening.;For more exclusion criteria please refer to the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoints<br /><br>The pharmacokinetic parameter AUC0-inf will be used to evaluate the relative<br /><br>bioavailability.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoints<br /><br>* Safety and tolerability parameters including adverse events (AEs), physical<br /><br>examination, clinical laboratory values, vital signs, and ECG after single dose<br /><br>administration of the capsule under fasted condition and the film-coated tablet<br /><br>under fasted and fed conditions.<br /><br>* Pharmacokinetic parameters of ASN120290 and ASN120460 in plasma after single<br /><br>dose administration of the capsule under fasted condition and the film-coated<br /><br>tablet under fasted and fed conditions.</p><br>