check_circleStudy Completed
Clinical Pharmacology
Bayer Identifier:
16537
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Single / multiple dose study in Chinese subjects
Trial purpose
Primary objective was
• to investigate the pharmacokinetics (PK) of finerenone in Chinese healthy male subjects
Secondary objective was
• to investigate the safety and tolerability of finerenone in Chinese healthy male subjects
• to investigate the pharmacokinetics (PK) of finerenone in Chinese healthy male subjects
Secondary objective was
• to investigate the safety and tolerability of finerenone in Chinese healthy male subjects
Key Participants Requirements
Sex
MaleAge
18 - 45 YearsTrial summary
Enrollment Goal
24Trial Dates
August 2017 - March 2018Phase
Phase 1Could I Receive a placebo
YesProducts
Kerendia (Finerenone, BAY94-8862)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | The 307th Hospital of Chinese People’s Liberation Army | Beijing, 100071, China |
Primary Outcome
- Cmax: maximum observed drug concentration in plasma after single dosingdate_rangeTime Frame:Day 1
- AUC: area under the plasma concentration vs. time curve from zero to infinity after single (first) dosedate_rangeTime Frame:Day 1
- Cmax/D: Cmax divided by dosedate_rangeTime Frame:Day 1
- AUC/D: AUC divided by dosedate_rangeTime Frame:Day 1
- Cmax,norm: Cmax divided by dose per body weightdate_rangeTime Frame:Day 1
- AUCnorm: AUC divided by dose per body weightdate_rangeTime Frame:Day 1
- Cmax,md: Cmax after multiple dosingdate_rangeTime Frame:Day 9
- AUCτ,md: AUCτ after multiple dose administrationdate_rangeTime Frame:Day 9
- Cmax,md/D: Cmax,md divided by dosedate_rangeTime Frame:Day 9
- AUCτ,md/D: AUCτ,md divided by dosedate_rangeTime Frame:Day 9
- Cmax,md,norm: Cmax,md divided by dose per body weightdate_rangeTime Frame:Day 9
- AUCτ,md,norm: AUCτ,md divided by dose per body weightdate_rangeTime Frame:Day 9
Secondary Outcome
- Number of participants with Treatment-emergent adverse eventsdate_rangeTime Frame:AE had started or worsened after first administration of study medication up to 3 days after end of treatment
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
RandomizedBlinding
N/AAssignment
Parallel AssignmentTrial Arms
2