Safety, tolerability and pharmacokinetic study of BIIX 1 XX in healthy male volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
single doses of 800, 1000, 1200, 1400, 1600, 1800, or 2000 mcg
Number of patients with adverse events
Time frame: up to 22 days
Number of patients with clinically relevant changes in vital parameters (Blood pressure, Pulse rate)
Time frame: up to 8 days after drug administration
Number of patients with clinically relevant changes in electrocardiogram (ECG)
Time frame: up to 8 days after drug administration
Number of patients with clinically relevant changes in impedance cardiography
Time frame: pre-dose, 10 and 30 minutes after administration
Number of patients with clinically relevant changes in cutaneous microcirculation
Time frame: pre-dose, 10 and 30 minutes after administration
Number of patients with clinically relevant changes in safety laboratory parameters
Time frame: up to 8 days after drug administration
Maximum concentration of the drug in plasma (Cmax)
Time frame: up to 168 hours after drug administration
Area under the plasma drug concentration-time curve from zero time to the last time point of measurement (AUC0-tz)
Time frame: up to 168 hours after drug administration
Terminal half-life of the analyte in plasma (t1/2)
Time frame: up to 168 hours after drug administration
Clearance, divided by f (CL/f)
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Time frame: up to 168 hours after drug administration