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Study of Ascending Single Oral Dose of GT-002 in Healthy Volunteers

NCT03817346 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2020-02-05

No results posted yet for this study

Summary

This study does not target any disease or condition in itself, but is evaluating the safety, tolerability and pharmacokinetics of single oral doses of GT-002 in the setting of healthy volunteers.

A longer-term objective is to apply the findings from this study to design and later conduct a clinical development programme of GT-002 as a medication to treat schizophrenia.

Conditions

  • Safety and Tolerability

Interventions

DRUG

GT-002

Single ascending dose

DRUG

Placebo oral capsule

Comparator single ascending dose

Sponsors & Collaborators

  • Smerud Medical Research International AS

    collaborator OTHER

  • Gabather AB

    lead INDUSTRY

Principal Investigators

  • Yvonne Peltonen · Smerud Medical Research Finland Ab/Oy

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-12-17
Primary Completion
2019-03-31
Completion
2019-05-31

Countries

  • Finland

Study Locations

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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 NCT03817346 on ClinicalTrials.gov