Study of Ascending Single Oral Dose of GT-002 in Healthy Volunteers (GAB-001)
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|ClinicalTrials.gov Identifier: NCT03817346|
Recruitment Status : Completed
First Posted : January 25, 2019
Last Update Posted : February 5, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Safety and Tolerability||Drug: GT-002 Drug: Placebo oral capsule||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Single ascending dose|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||Double blinde|
|Primary Purpose:||Basic Science|
|Official Title:||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|
|Actual Study Start Date :||December 17, 2018|
|Actual Primary Completion Date :||March 31, 2019|
|Actual Study Completion Date :||May 31, 2019|
Active Comparator: Experimental GT-002 SAD
Healthy volunteers meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 7 dose ascending cohorts) to receive either GT-002 or placebo. The study drug (GT-002 or placebo) will be administered orally as a single dose. Six of out 8 subjects per cohort will be randomized to receive GT-002.
Single ascending dose
Placebo Comparator: Experimental Placebo oral capsule SAD
Healthy volunteers meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 7 dose ascending cohorts) to receive either GT-002 or placebo. The study drug (GT-002 or placebo) will be administered orally as a single dose. Two of out 8 subjects per cohort will be randomized to receive GT-002.
Drug: Placebo oral capsule
Comparator single ascending dose
- Adverse Events (AEs) [ Time Frame: Day 1 to day 3 ]To evaluate the safety and tolerability GT-002 in healthy subjects by assessing the number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs
- Pharmacokinetic parameter AUCt [ Time Frame: Day1 to day 3 ]Area under the curve from the time of dosing until the last quantifiable concentration
- Pharmacokinetic parameter AUC0-24 [ Time Frame: Day1 to day 2 ]Area under the curve from the time of dosing until 24 hours post dosing
- Pharmacokinetic parameter AUC0-infinity [ Time Frame: day 1 to day 3 ]Area under the curve from the time of dosing extrapolated to infinity
- Pharmacokinetic parameter Cmax [ Time Frame: Day 1 to day 3 ]Maximum concentration (Cmax)
- tmax [ Time Frame: Day 1 to day 3 ]Time to maximum concentration
- t1/2 [ Time Frame: Day 1 to day 3 ]Apparent terminal elimination half-life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817346
|CRST Oy, Clinical Research Services Turku|
|Turku, Finland, 20520|
|Study Chair:||Yvonne Peltonen||Smerud Medical Research Finland Ab/Oy|