A Single Ascending Oral Dose Study of SDI-118 in Healthy Male Subjects Including an Assessment of Receptor Occupancy and Food Effect

Summary

This is a First-in-Human, Randomized, Placebo-controlled, Single Ascending Oral Dose Study of SDI-118 in Healthy Male Subjects including Receptor Occupancy Measurements after Single Dose of SDI-118 and an Assessment of Food Effect.

Timeline

Start

2019-03-14

Primary completion

2019-07-29

Completion

2020-03-11

Publications

• Botermans W, Koole M, Van Laere K, Savidge JR, Kemp JA, Sunaert S, Duffy MM, Ramael S, Cesura AM, D'Ostilio K, Gossen D, Madsen TM, Lodeweyckx T, de Hoon J. SDI-118, a novel procognitive SV2A modulator: First-in-human randomized controlled trial including PET/fMRI assessment of target engagement. Front Pharmacol. 2023 Jan 17;13:1066447. doi: 10.3389/fphar.2022.1066447. eCollection 2022.

Drugs

Indications