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

NCT05486195 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-08-03

No results posted yet for this study

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.

Conditions

  • Cognitive Disorders

Interventions

DRUG

SDI-118

SDI-118 Powder in Capsule

DRUG

Placebo

Matching Placebo

Sponsors & Collaborators

  • Syndesi Therapeutics

    collaborator INDUSTRY

  • KU Leuven

    collaborator OTHER

  • AbbVie

    lead INDUSTRY

Principal Investigators

  • Jan deHoon, MD · UZ Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-14
Primary Completion
2019-07-29
Completion
2020-03-11

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05486195 on ClinicalTrials.gov