Trial Condition(s):
Clinical Pharmacology
Asian single dose escalation study
Bayer Identifier:
15528
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Inclusion Criteria
- 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.
Exclusion Criteria
No Exclusion Criteria Available
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Singapore, Singapore, 529889 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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
Primary Outcome
- Cmax: maximum total (bound and unbound) drug concentration in plasma after single dose administrationTimeframe:
- AUC: area under the plasma concentration vs time curve from zero to infinity for total (bound and unbound) drug after single doseTimeframe:
- Cmax,norm: Cmax divided by dose per kg body weightTimeframe:
- AUCnorm: AUC divided by dose per kg body weightTimeframe:
- Cmax/D: Cmax divided by doseTimeframe:
- AUC/D: AUC divided by doseTimeframe:
Secondary Outcome
- AUC(0-48): AUC from time 0 to 48 hours after study drug administrationTimeframe:
- AUC(0-tlast): AUC from time 0 to the last data pointTimeframe:
- t1/2: half-life associated with the terminal slopeTimeframe:
- tmax: time to reach Cmax (in case of 2 identical Cmax values, the first tmax is to be used)Timeframe:
- MRT: mean residence timeTimeframe:
- CL/F: total body clearance of drug calculated after extravascular administration (eg apparent oral clearance)Timeframe:
- Vz/F: apparent volume of distribution during terminal phase after extravascular administrationTimeframe:
- AE,ur(t1-t2): amount excreted into urine from time t1 to time t2Timeframe:
- AE,ur: amount excreted into urine from 0 to infinityTimeframe:
- CLR: renal body clearance of drugTimeframe:
Additional Information
Not Available
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