The study will investigate the effect of single dose and multiple doses of M2951 on midazolam Pharmacokinetics (PK) in healthy participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
16
Nuvisan GmbH
Neu-Ulm, Germany
Area Under the Plasma Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of Midazolam
Time frame: Pre-dose through 24 hours postdose on Days 1, 3 and 13
Maximum Observed Plasma Concentration (Cmax) of Midazolam
Time frame: Pre-dose through 24 hours postdose on Days 1, 3 and 13
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 14
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) by Severity
Time frame: Up to Day 14
Number of Participants with Clinically Significant Change From Baseline in Laboratory Parameters, Vital Signs and 12-Lead Electrocardiogram (ECG) Findings
Number of participants with clinically significant change from baseline in laboratory parameters, vital signs and 12- lead ECG findings will be reported.
Time frame: Up to Day 14
Area Under the Plasma Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of 1-hydroxymidazolam
Time frame: Pre-dose through 24 hours postdose on Days 1, 3 and 13
Maximum Observed Plasma Concentration (Cmax) of 1-hydroxymidazolam
Time frame: Pre-dose through 24 hours postdose on Days 1, 3 and 13
Time to Reach Maximum Plasma Concentration (tmax) of Midazolam and 1-hydroxymidazolam
Time frame: Pre-dose through 24 hours postdose on Days 1, 3 and 13
Apparent Terminal Half-life (t1/2) of Midazolam and 1-hydroxymidazolam
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Pre-dose through 24 hours postdose on Days 1, 3 and 13
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC0-t) of Midazolam and 1-hydroxymidazolam
Time frame: Pre-dose through 24 hours postdose on Days 1, 3 and 13
Apparent Total Body Clearance (CL/F) of Midazolam
Time frame: Pre-dose through 24 hours postdose on Days 1, 3 and 13
Apparent Volume of Distribution (Vz/F) of Midazolam
Time frame: Pre-dose through 24 hours postdose on Days 1, 3 and 13