NCT03817346

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

A Phase I, Randomised, Double-blind, Placebo-controlled Study in Healthy Male Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of Ascending Single Oral Doses of GT-002

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Gabather AB · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DRUG	GT-002	Single ascending dose
DRUG	Placebo oral capsule	Comparator single ascending dose

Timeline

• Start date: 2018-12-17
• Primary completion: 2019-03-31
• Completion: 2019-05-31
• First posted: 2019-01-25
• Last updated: 2020-02-05

Locations

1 site across 1 country: Finland