A Phase 1 interventional study of Molidustat(BAY85-3934) and Molidustat(BAY85-3934) in Renal Insufficiency, Chronic, sponsored by Bayer. Completed at 2 sites in Germany. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-25.
Sponsored by Bayer · Phase 1, Interventional, and Other
The study investigates the pharmacokinetics (absorption, distribution, elimination) of molidustat after intake of a single 75 mg tablet in subjects with renal impairment requiring hemo- or peritoneal dialysis compared to age-and gender-matched healthy subjects. In addition, the effect of molidustat on the hormone erythropoietin will be evaluated as well as the safety and tolerability of molidustat.
1,994 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
This study's enrollment of 40 is close to the median of 43 across 1,503 interventional studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Single oral dose of 75 mg molidustat (fasted) in subjects on hemodialysis (at start of hemodialysis and on a hemodialysis free day,respectively)
Drug: Molidustat(BAY85-3934)
Single oral dose of 75 mg molidustat (fasted) in subjects on peritoneal dialysis (after start of peritoneal dialysis intervall and, optionally, after the start of a peritoneal dialysis-free intervall,respectively)
Drug: Molidustat(BAY85-3934)
Single oral dose of 75 mg molidustat (fasted) in healthy subjects
Drug: Molidustat(BAY85-3934)
Two single oral doses of 75 mg molidustat tablet in subjects on hemodialysis and peritoneal dialysis
One single oral dose of 75 mg molidustat in healthy subjects
Pharmacokinetics characterized by Cmax of Molidustat
Cmax: maximum drug concentration in plasma after single dose administration
Time frame: Up to 96 hours post dose
Pharmacokinetics characterized by AUC of Molidustat
AUC: area under the plasma concentration vs time curve from zero to infinity
Time frame: Up to 96 hours post dose
Pharmacokinetics characterized by Cmax,norm of Molidustat
Cmax,norm;maximum drug concentration in plasma after single dose administration divided by dose (milligrams) per kilogram body weight
Time frame: Up to 96 hours post dose
Pharmacokinetics characterized by (AUCnorm) of Molidustat
AUCnorm; area under the plasma concentration vs time curve divided by dose per kg body weight
Time frame: Up to 96 hours post dose
Pharmacokinetics characterized by Cmax of erythropoietin
Cmax: maximum drug concentration in plasma after single dose administration
Time frame: Up to 48 hours post dose
Pharmacokinetics characterized by AUC (0-tlast) of erythropoietin
AUC(0-tlast): AUC from time 0 to the last data point above lower limit of quantification
Time frame: Up to 48 hours post dose
Pharmacokinetics characterized by tmax of erythropoietin
tmax: time to reach maximum drug concentration in plasma after single (first) dose
Time frame: Up to 48 hours post dose
Number of subjects with Treatment Emergent Adverse Event (TEAE)
Time frame: Up to 7 days post dose
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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