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

Key Participants Requirements

Sex

Male

Age

18 - 45 Years
  • - Healthy male Chinese subjects, aged ≥ 18 to ≤ 45 years, with a body mass index (BMI) ≥ 19.0 and ≤ 24 kg/m^2.

  • -

Trial summary

Enrollment Goal
24
Trial Dates
August 2017 - March 2018
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Kerendia (Finerenone, BAY94-8862)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
The 307th Hospital of Chinese People’s Liberation ArmyBeijing, 100071, China

Primary Outcome

  • Cmax: maximum observed drug concentration in plasma after single dosing
    date_rangeTime Frame:
    Day 1
  • AUC: area under the plasma concentration vs. time curve from zero to infinity after single (first) dose
    date_rangeTime Frame:
    Day 1
  • Cmax/D: Cmax divided by dose
    date_rangeTime Frame:
    Day 1
  • AUC/D: AUC divided by dose
    date_rangeTime Frame:
    Day 1
  • Cmax,norm: Cmax divided by dose per body weight
    date_rangeTime Frame:
    Day 1
  • AUCnorm: AUC divided by dose per body weight
    date_rangeTime Frame:
    Day 1
  • Cmax,md: Cmax after multiple dosing
    date_rangeTime Frame:
    Day 9
  • AUCτ,md: AUCτ after multiple dose administration
    date_rangeTime Frame:
    Day 9
  • Cmax,md/D: Cmax,md divided by dose
    date_rangeTime Frame:
    Day 9
  • AUCτ,md/D: AUCτ,md divided by dose
    date_rangeTime Frame:
    Day 9
  • Cmax,md,norm: Cmax,md divided by dose per body weight
    date_rangeTime Frame:
    Day 9
  • AUCτ,md,norm: AUCτ,md divided by dose per body weight
    date_rangeTime Frame:
    Day 9

Secondary Outcome

  • Number of participants with Treatment-emergent adverse events
    date_rangeTime Frame:
    AE had started or worsened after first administration of study medication up to 3 days after end of treatment

Trial design

A single-center, randomized, placebo-controlled, single-blind study to investigate the pharmacokinetics, safety and tolerability of single and multiple oral doses of finerenone in Chinese healthy adult male subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Parallel Assignment
Trial Arms
2