The primary purpose of this first-in-man study is to investigate whether a new drug for neurological disorders is safe and well-tolerated when administered orally to healthy adults
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
128
Investigator Site
Berlin, Germany
Number of participants with adverse events (AEs)
Treatment-emergent adverse events and treatment-emergent serious adverse events
Time frame: Up to end of study (up to Day 11)
Changes from baseline in vital signs
Vital signs include diastolic and systolic blood pressure and pulse rate
Time frame: Up to end of study (up to Day 11)
Changes from baseline in ECG variables
ECG variables are to be recorded at rest using a standard 12-lead ECG
Time frame: Up to end of study (up to day 11)
Maximum plasma concentration (Cmax) following single ascending doses
Cmax is derived from the observed plasma concentration-time curves
Time frame: From pre-dose on Day 1 to 96 hours post dose
Time to reach Cmax (tmax) following single ascending doses
tmax is derived from the observed plasma concentration-time curves
Time frame: From pre-dose on Day 1 to 96 hours post dose
Terminal half-life [t(1/2)] following single ascending doses
Time frame: From pre-dose on Day 1 to 96 hours post dose
Area under the plasma concentration-time curve (AUC) following single ascending doses
AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification \[AUC(0-t)\] and from zero to infinity \[AUC(0-inf)\]
Time frame: From pre-dose on Day 1 to 96 hours post dose
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Maximum plasma concentration (Cmax) following multiple ascending doses
Time frame: Up to 96 hours following the last dose administration on Day 4
Time to reach Cmax (tmax) following multiple ascending doses
Time frame: Up to 96 hours following the last dose administration on Day 4
Terminal half-life [t(1/2)] following multiple ascending doses
t(1/2) on the last day of dosing
Time frame: Up to 96 hours following the last dose administration on Day 4
Area under the plasma concentration-time curve during a dosing interval (AUCtau)
AUCtau is the area under the plasma concentration-time curve during a dosing interval
Time frame: Day 1 and Day 4