check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

15171

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
Single/multiple dose escalation study in Japanese subjects

Trial purpose

The primary objective
•To investigate the safety and tolerability of BAY 94-8862 after single and multiple oral doses of 10 mg BID, 20 mg BID and 40 mg OD administered as 10 mg IR tablets in Japanese healthy adult male subjects
The secondary objective
•To investigate the pharmacodynamics and pharmacokinetics of BAY 94-8862 in Japanese healthy adult male subjects

Key Participants Requirements

Sex

Male

Age

20 - 45 Years
  • - Japanese healthy adult male subjects, 20 to 45 years of age, with body mass index between 17.6 to 26.4 kg/m^2 inclusive

  • -

Trial summary

Enrollment Goal
36
Trial Dates
February 2012 - July 2012
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Kagoshima, 890-0081, Japan

Primary Outcome

  • Cmax: maximum drug concentration in plasma after single dosing
    date_rangeTime Frame:
    Day 1
  • Cmax,md: Cmax after multiple 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
  • AUC/D: AUC divided by dose (mg)
    date_rangeTime Frame:
    Day 1
  • AUCτ,md: AUCτ after multiple dose administration
    date_rangeTime Frame:
    Day 10
  • AUCτ,md/D: AUCτ,md divided by dose
    date_rangeTime Frame:
    Day 10
  • Cmax,md: Cmax after multiple dosing
    date_rangeTime Frame:
    Day 10
  • Cmax,md/D: Cmax,md divided by dose
    date_rangeTime Frame:
    Day 10

Secondary Outcome

  • AUC(0-tlast): AUC from time 0 to the last data point
    date_rangeTime Frame:
    Day 1
  • AUC(0-tlast)/D: AUC(0-tlast) divided by dose
    date_rangeTime Frame:
    Day 1
  • AUCnorm: AUC divided by dose per kg body weight
    date_rangeTime Frame:
    Day 1
  • Cmax,norm: Cmax divided by dose (mg) per kg body weight
    date_rangeTime Frame:
    Day 1
  • t1/2: half-life associated with the terminal slope
    date_rangeTime Frame:
    Day 1
  • tmax: time to reach maximum drug concentration in plasma after single dosing
    date_rangeTime Frame:
    Day 1
  • MRT: mean residence time
    date_rangeTime Frame:
    Day 1
  • CL/F: total body clearance of drug from plasma calculated after oral administration (apparent oral clearance)
    date_rangeTime Frame:
    Day 1
  • AUCτ,md,norm: AUCτ,md divided by dose (mg) per kg body weight
    date_rangeTime Frame:
    Day 10
  • Cmax,md,norm: Cmax,md divided by dose (mg) per kg body weight
    date_rangeTime Frame:
    Day 10
  • tmax: time to reach maximum drug concentration in plasma after single dosing
    date_rangeTime Frame:
    Day 10
  • t1/2
    date_rangeTime Frame:
    Day 10
  • MRT
    date_rangeTime Frame:
    Day 10
  • CL/f
    date_rangeTime Frame:
    Day 10
  • C(24)/Cmax: observed concentration at time 24 hours divided by maximum observed drug concentration
    date_rangeTime Frame:
    Day 10
  • accumulation ratios RACmax (accumulation ratio calculated from Cmax after multiple dosing and Cmax after single dosing)
    date_rangeTime Frame:
    Day 10
  • RLin: linearity factor of pharmacokinetics after multiple administration of identical doses calculated from AUCt after multiple dosing and AUC after single dosing
    date_rangeTime Frame:
    Day 10
  • RAAUC: accumulation ratio calculated from AUCτ after multiple dosing and AUCτ after single dosing
    date_rangeTime Frame:
    Day 10
  • AE,ur(0-24): amount excreted into urine from 0 to 24 hours
    date_rangeTime Frame:
    Day 10
  • CLR
    date_rangeTime Frame:
    Day 10

Trial design

A single-center, randomized, single-blinded, placebo-controlled, group-comparison, combined single/multiple dose escalation study to investigate the safety, tolerability, pharmacodynamics and pharmacokinetics of BAY 94-8862 in Japanese healthy adult male subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Sequential Assignment
Trial Arms
2