The primary purpose of this study is to assess the effect of mitapivat on the single oral dose pharmacokinetics (PK) of midazolam in healthy participants.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Fortrea Clinical Research Unit Inc.
Dallas, Texas, United States
Area Under the Plasma Concentration-Time Curve Extrapolated From Time Zero to Infinity (AUC0-infinity) of Midazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-t) of Midazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Maximum Observed Plasma Concentration (Cmax) of Midazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Area Under the Plasma Concentration-Time Curve From Time Zero to 12 Hours Post-dose (AUC0-12) of Mitapivat
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Maximum Observed Plasma Concentration (Cmax) of Mitapivat
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Area Under the Plasma Concentration-Time Curve Over a Dosing Interval (Tau) at Steady State (AUC0-tau,ss) of Mitapivat
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of Mitapivat
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Time to Last Measurable Concentration (tlast) of Mitapivat
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Time to Reach Maximum Concentration (tmax) of Mitapivat
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-infinity) of 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-t) of 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Maximum Observed Plasma Concentration (Cmax) of 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Metabolite-to-Parent Ratio of Area Under the Plasma Concentration-Time Curve Extrapolated to Infinity (AUC0-infinity) for Midazolam and 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Metabolite-to-Parent Ratios of Area Under the Plasma Concentration-Time Curve From Time Zero to the Time of Last Quantifiable Concentration (AUC0-t) for Midazolam and 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Metabolite-to-Parent Ratio of Maximum Observed Plasma Concentration (Cmax) for Midazolam and 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Percentage of Area Under the Concentration-Time Curve Due to Extrapolation From the Last Quantifiable Concentration to Infinity (AUC%extrap) of Midazolam and 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Time to Last Measurable Concentration (tlast) of Midazolam and 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Time to Reach Maximum Concentration (tmax) of Midazolam and 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Terminal Elimination Half-Life (t1/2) of Midazolam and 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Apparent Total Body Clearance (CL/F) of Midazolam and 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Apparent Volume of Distribution During the Terminal Phase (Vz/F) of Midazolam and 1'-hydroxymidazolam
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 14
Number of Participants With Adverse Events (AEs), AEs by Severity, and Relatedness to Study Treatment
Time frame: Up to Day 24
Number of Participants With Clinically Significant Change From Baseline in Clinical Laboratory Assessments
Time frame: Baseline up to Day 24
Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Parameters
Time frame: Baseline up to Day 14
Number of Participants With Clinically Significant Change From Baseline in Vital Signs Parameters
Time frame: Baseline up to Day 24