Clinical Trial: First in Man Clinical Trial of Emodepside (BAY 44-4400)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase 1, Blinded, Randomized, Placebo Controlled, Parallel-Group, Single-Dose, Dose-Escalation Study to Investigate Safety, Tolerability, and Pharmacokinetics of Emodepside (BAY 44-4400) After Oral
Brief Summary: This study will investigate the safety, tolerability, and pharmacokinetics of single ascending doses of emodepside (BAY 44-4400) in healthy male volunteers. This study will also conduct an exploratory investigation of the relative bioavailability of emodepside administered as tablets.
Detailed Summary:
Sponsor: Drugs for Neglected Diseases
Current Primary Outcome: Safety and tolerability as measured by adverse events, physical and neurological examination findings, vital signs and 12-lead ECG, and clinical laboratory parameters. [ Time Frame: up to 14 days post dose (may be extended to 21 days) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The AUC∞ (the area under the plasma drug concentration vs. time curve from time zero to infinity) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The AUC∞/D (the area under the plasma drug concentration vs. time curve from time zero to infinity, corrected for dose) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The Cmax (the observed maximum plasma concentration) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The Cmax/D (the observed maximum plasma concentration, corrected for dose) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The Cmax,norm (the observed maximum plasma concentration corrected by dose and body weight) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The Tmax (the time at which Cmax was apparent) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The t½ (the terminal half-life) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The MRT (the mean residence time) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The CL/F (the apparent total clearance from plasma) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The AUC∞,norm (the area under the concentration-time curve from time zero to infinity corrected by dose and body weight) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The AUCt (the area under the concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The AUC t,norm (the area under the concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration corrected by dose and body weight) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The Vz/F (the apparent volume of distribution) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The lambda-z (the terminal rate constant) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The AUC t-∞ (the area under the concentration-time curve from time t to infinity) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The points terminal of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The relative bioavailability (Frel) of the IR (immediate release) tablet of emodepside will be calculated (optionally). [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The AUC∞ (the area under the plasma drug concentration vs. time curve from time zero to infinity) of metabolites of emodepside in plasma may be measured [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The AUC∞/D (the area under the plasma drug concentration vs. time curve from time zero to infinity, corrected for dose) of metabolites of emodepside in plasma may be measured [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The Cmax (the observed maximum plasma concentration) of metabolites of emodepside in plasma may be measured [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The Cmax/D (the observed maximum plasma concentration, corrected for dose) of metabolites of emodepside in plasma may be measured [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The Cmax,norm (the observed maximum plasma concentration corrected by dose and body weight) of metabolites of emodepside in plasma may be measured [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The Tmax (the time at which Cmax was apparent) of metabolites of emodepside in plasma may be measured [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The t½ (the terminal half-life) of metabolites of emodepside in plasma may be measured [&nb
Original Secondary Outcome:
- The AUC∞ (the area under the plasma drug concentration vs. time curve from time zero to infinity) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The AUC∞/D (the area under the plasma drug concentration vs. time curve from time zero to infinity, corrected for dose) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The Cmax (the observed maximum plasma concentration) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The Cmax/D (the observed maximum plasma concentration, corrected for dose) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The Cmax,norm (the observed maximum plasma concentration corrected by dose and body weight) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The Tmax (the time at which Cmax was apparent) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The t½ (the terminal half-life) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The MRT (the mean residence time) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The CL/F (the apparent total clearance from plasma) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The AUC∞,norm (the area under the concentration-time curve from time zero to infinity corrected by dose and body weight) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The AUCt (the area under the concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The AUC t,norm (the area under the concentration-time curve from time zero (pre-dose) to the time of last quantifiable concentration corrected by dose and body weight) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The Vz/F (the apparent volume of distribution) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The lambda-z (the terminal rate constant) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The AUC t-∞ (the area under the concentration-time curve from time t to infinity) of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The points terminal of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The relative bioavailability (Frel) of the IR (immediate release) tablet of emodepside will be calculated (optionally). [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The AUC∞ (the area under the plasma drug concentration vs. time curve from time zero to infinity) of metabolites of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The AUC∞/D (the area under the plasma drug concentration vs. time curve from time zero to infinity, corrected for dose) of metabolites of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The Cmax (the observed maximum plasma concentration) of metabolites of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The Cmax/D (the observed maximum plasma concentration, corrected for dose) of metabolites of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The Cmax,norm (the observed maximum plasma concentration corrected by dose and body weight) of metabolites of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The Tmax (the time at which Cmax was apparent) of metabolites of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
- The t½ (the terminal half-life) of metabolites of emodepside in plasma. [ Time Frame: from pre-dose until 336h post-dose (may be extended to 504h post-dose) ]
Information By: Drugs for Neglected Diseases
Dates:
Date Received: January 15, 2016
Date Started: December 2015
Date Completion: March 2017
Last Updated: January 31, 2017
Last Verified: January 2017