NCT05486195 is a Phase 1 clinical trial of SDI-118 in Cognitive Disorders, sponsored by AbbVie.

Who is sponsoring NCT05486195?

NCT05486195 is sponsored by AbbVie.

What drugs are being tested in NCT05486195?

Interventions in NCT05486195: SDI-118, Placebo.

What condition does NCT05486195 study?

NCT05486195 studies Cognitive Disorders.

Is NCT05486195 still recruiting?

NCT05486195 is currently completed. Last updated 3 August 2022.

Last reviewed 2022-08-03 · How we verify

NCT05486195

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 3 August 2022

What this trial tests

Phase 1 trial testing SDI-118 in Cognitive Disorders in 32 participants. Completed in 11 March 2020.

Timeline

14 March 2019

Primary endpoint
29 July 2019

11 March 2020

Quick facts

Lead sponsor	AbbVie
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	triple
Primary purpose	treatment
Enrollment	32
Start date	14 March 2019
Primary completion	29 July 2019
Estimated completion	11 March 2020
Sites	1 location across Belgium

Drugs / interventions tested

SDI-118 — full drug profile →
Placebo

Conditions studied

Cognitive Disorders — all drugs for Cognitive Disorders →

Sponsor

AbbVie — full company profile →

Who can join

Adults 18 to 50, male only, with Cognitive Disorders. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

SDI-118, a novel procognitive SV2A modulator: First-in-human randomized controlled trial including PET/fMRI assessment of target engagement.
Botermans W, Koole M, Van Laere K, Savidge JR, et al · · 2022 · cited 6× · PMID 36733374 · DOI 10.3389/fphar.2022.1066447
Advances in synaptic PET imaging and intervention with synapse-targeted small-molecular drugs for dementia diagnosis and therapy.
Lu X, Ji B, Huang G, Ding H. · · 2025 · cited 1× · PMID 40166112 · DOI 10.1016/j.fmre.2024.04.013

Verify or expand the search:

Other trials of SDI-118

Trials testing the same drug.

NCT05199142 — A Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of SDI-118 in Elderly Male and Female Study Participa · Phase 1 · terminated
NCT05212116 — A Study of SDI-118 in Participants in Remission From Depression · Phase 1 · withdrawn

Other recruiting trials for Cognitive Disorders

Currently open trials in the same condition.

NCT06895109 — Cognitive Functions in Severe Acquired Brain Injury After Cranioplasty · active not recruiting
NCT06964581 — Cognitive Rehabilitation of Deficits in Patients With Multiple Sclerosis · NA · recruiting

Other AbbVie trials

Trials by the same sponsor.

NCT07219017 — A Study to Assess the Mass Balance of Oral ABBV-1354 in Healthy Adult Male Participants · Phase 1 · completed
NCT05316220 — A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years W · Phase 3 · withdrawn
NCT07024797 — Study to Assess the Adverse Events, Tolerability, and How Oral Doses of ABBV-932 Moves Through the Body in Healthy Adult · Phase 1 · completed
NCT07058051 — Cross-sectional Study to Characterize Real World Burden of Disease in Patients With Vitiligo in China · completed
NCT07007091 — A Study to Assess the Relative Bioavailability of Risankizumab Following Subcutaneous Administrations With a Pre-Filled · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05486195 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AbbVie
Last refreshed: 3 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05486195.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing