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 male adults
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
72
Investigator Site
Berlin, Germany
Number of participants with adverse events (AEs)
Treatment-emergent AEs and treatment emergent serious AEs
Time frame: From baseline to end of study (EOS) (up to Day 12)
Changes from baseline in supine blood pressure
Supine blood pressure (mmHg)
Time frame: From baseline to EOS (up to Day 12)
Changes from baseline in electrocardiogram (ECG) variables
ECG variables are to be recorded at rest using a standard 12-lead ECG
Time frame: From baseline to EOS (up to Day 12)
Changes from baseline in pulse rate
Pulse rate (bpm)
Time frame: From baseline to EOS (up to Day 12)
Maximum plasma concentration (Cmax) following single oral ascending doses
Cmax is derived from the observed plasma concentration-time curves
Time frame: From pre-dose on Day 1 to up to Day 12
Time to reach Cmax (tmax) following single oral ascending doses
Tmax is derived from the observed plasma concentration-time curves
Time frame: From pre-dose on Day 1 to up to Day 12
Terminal half-life [t(1/2)] following single oral ascending doses
Time frame: From pre-dose on Day 1 to up to Day 12
Area under the plasma concentration-time curve (AUC) following single oral ascending doses
AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification, from zero to infinity and from zero to 24 h after study drug administration
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Time frame: From pre-dose on Day 1 to up to Day 12