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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
32
Single ascending dose
Comparator single ascending dose
CRST Oy, Clinical Research Services Turku
Turku, Finland
Adverse Events (AEs)
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
Time frame: Day 1 to day 3
Pharmacokinetic parameter AUCt
Area under the curve from the time of dosing until the last quantifiable concentration
Time frame: Day1 to day 3
Pharmacokinetic parameter AUC0-24
Area under the curve from the time of dosing until 24 hours post dosing
Time frame: Day1 to day 2
Pharmacokinetic parameter AUC0-infinity
Area under the curve from the time of dosing extrapolated to infinity
Time frame: day 1 to day 3
Pharmacokinetic parameter Cmax
Maximum concentration (Cmax)
Time frame: Day 1 to day 3
tmax
Time to maximum concentration
Time frame: Day 1 to day 3
t1/2
Apparent terminal elimination half-life
Time frame: Day 1 to day 3
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