check_circleStudy Completed

Clinical Pharmacology

Bayer Identifier:

15528

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available
Asian single dose escalation study

Trial purpose

The primary objective of the study was
• to investigate the safety and tolerability of BAY94-8862 after single oral doses of 1.25, 10, and 40 mg BAY 94 8862 administered as immediate-release (IR) tablets containing 1.25 mg and 10 mg BAY94-8862, respectively, in Asian (Chinese) healthy male subjects
The secondary objectives of this study was
• to investigate the pharmacokinetics of BAY94-8862 and its 3 metabolites M1 (BAY1040818), M2 (BAY1088089), and M3 (BAY1088090) in Asian (Chinese) healthy male subjects

Key Participants Requirements

Sex

Male

Age

21 - 45 Years
  • - Healthy young male Asian (Chinese) subjects, 21 to 45 years of age, with body mass index between 18.0 and 29.9 kg/m2 inclusive were planned to be enrolled.

  • -

Trial summary

Enrollment Goal
36
Trial Dates
September 2011 - December 2012
Phase
Phase 1
Could I Receive a placebo
Yes
Products
Finerenone (BAY94-8862)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Singapore, 529889, Singapore

Primary Outcome

  • Cmax: maximum total (bound and unbound) drug concentration in plasma after single dose administration
  • AUC: area under the plasma concentration vs time curve from zero to infinity for total (bound and unbound) drug after single dose
  • Cmax,norm: Cmax divided by dose per kg body weight
  • AUCnorm: AUC divided by dose per kg body weight
  • Cmax/D: Cmax divided by dose
  • AUC/D: AUC divided by dose

Secondary Outcome

  • AUC(0-48): AUC from time 0 to 48 hours after study drug administration
  • AUC(0-tlast): AUC from time 0 to the last data point
  • t1/2: half-life associated with the terminal slope
  • tmax: time to reach Cmax (in case of 2 identical Cmax values, the first tmax is to be used)
  • MRT: mean residence time
  • CL/F: total body clearance of drug calculated after extravascular administration (eg apparent oral clearance)
  • Vz/F: apparent volume of distribution during terminal phase after extravascular administration
  • AE,ur(t1-t2): amount excreted into urine from time t1 to time t2
  • AE,ur: amount excreted into urine from 0 to infinity
  • CLR: renal body clearance of drug

Trial design

Single-center, randomized, double-blind, placebo-controlled, group-comparison, single dose escalation study to investigate safety, tolerability, and pharmacokinetics of BAY 94 8862 in Asian (Chinese) healthy adult male subjects
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Other
Allocation
Randomized
Blinding
N/A
Assignment
Sequential Assignment
Trial Arms
2