Trial Condition(s):
Clinical Pharmacology
Single and multiple dose phase I study in China
Bayer Identifier:
16964
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
The primary objective of this study was:
• To investigate the pharmacokinetics and pharmacodynamics of BAY1021189 after a single oral dose and multiple oral doses once daily over 7 days of 1.25 mg, 5 mg and 10 mg as IR tablets in Chinese healthy male subjects under fed condition
The secondary objectives of this study were:
• To investigate the safety and tolerability of BAY 1021189 in Chinese healthy male subjects
• To investigate the influence of different food (high fat/high calorie breakfast or standardized breakfast) on the pharmacokinetics of BAY1021189 in Chinese healthy adult male subjects
Inclusion Criteria
- Chinese healthy male volunteers, age 18-45 years
Exclusion Criteria
- Incompletely cured pre-existing diseases for which it was assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs was not normal - Known hypersensitivity to the study drugs (active substances or excipients of the preparations) - Known severe allergies, non-allergic drug reactions, or multiple drug allergies - Relevant diseases within the last 4 weeks prior to the first study drug administration - Febrile illness within 1 week before the first study drug administration - Subjects with lactose intolerance - Regular use of medicines - Regular use of therapeutic or recreational drugs - Use of systemic or topical medicines or substances which opposed the study objectives or which had the potential to influence them within 4 weeks before the first study drug administration
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Beijing, China, 100083 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Single-center, randomized, double-blind, placebo-controlled, single-dose and multiple-dose, parallel-group study to investigate pharmacokinetics, pharmacodynamics, safety and tolerability of BAY 1021189 in Chinese healthy male subjects under fed condition
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Randomized
Blinding:
N/A
Assignment:
N/A
Trial Arms:
4
Primary Outcome
- AUCArea under the plasma concentration vs time curve from zero to infinity after single (first) doseTimeframe: Day 0 to Day 4
- AUC/DAUC divided by dose (mg)Timeframe: Day 0 to Day 4
- AUCnormArea under the curve divided by dose per kg body weightTimeframe: Day 0 to Day 4
- AUC(0-24)AUC from time 0 to 24 hours after administrationTimeframe: Day 0 to Day 4 and Day 4 to Day 5
- AUC(0-24)/DAUC(0-24) by dose (mg)Timeframe: Day 0 to Day 4 and Day 4 to Day 5
- AUC(0-24)normAUC(0-24) divided by dose (mg) per kg body weightTimeframe: Day 0 to Day 4 and Day 4 to Day 5
- CmaxMaximum drug concentration in plasma after single dose administrationTimeframe: Day 0 to Day 4 and Day 4 to Day 5
- Cmax/DMaximum drug concentration in plasma after single dose administrationdivided by dose (mg)Timeframe: Day 0 to Day 4 and Day 4 to Day 5
- Cmax,normMaximum drug concentration in plasma after single dose administration divided by dose (mg) per kg body weightTimeframe: Day 0 to Day 4 and Day 4 to Day 5
- tmaxTime to reach maximum drug concentration in plasma after single (first) doseTimeframe: Day 4 to Day 5
- AUCτ,ss/DAUCτ,ss/D divided by dose (mg)Timeframe: Day 10 to Day 14
- AUCτ,ss,normAUCτ,ss divided by dose (mg) per kg body weightTimeframe: Day 10 to Day 14
- Cmax,ssMaximum drug concentration in plasma at steady state during a dosage intervalTimeframe: Day 10 to Day 14
- Cmax,ss/DMaximum drug concentration in plasma at steady state divided by dose (mg)Timeframe: Day 10 to Day 14
- Cmax,ss,normMaximum drug concentration in plasma at steady state during a dosage interval divided by dose (mg) per kg body weightTimeframe: Day 10 to Day 14
- Heart rate over 1 minTimeframe: Up to 4 h after administration of study drug
- Blood pressureTimeframe: Up to 4 h after administration of study drug
- Number of participants with treatment-emergent adverse events (TEAEs)Timeframe: From first study drug administration until 30 days after the last study drug administration
Secondary Outcome
- AUC(0-tlast)AUC from time 0 to the last data pointTimeframe: Day 0 to Day 4
- AUC(0-tlast)/DAUC(0-tlast) by dose (mg)Timeframe: Day 0 to Day 4
- AUC(0- tlast)normAUC(0-tlast) divided by dose (mg) per kg body weightTimeframe: Day 0 to Day 4
- tmaxTime to reach maximum drug concentration in plasma after single (first) doseTimeframe: Day 0 to Day 4 and Day 10 to Day 14
- t1/2Half-life associated with the terminal slopeTimeframe: Day 0 to Day 4 and Day 10 to Day 14
- MRTMean residence timeTimeframe: Day 0 to Day 4 and Day 10 to Day 14
- CL/FTotal body clearance of drug from plasma calculated after oral administration (apparent oral clearance)Timeframe: Day 0 to Day 4 and Day 10 to Day 14
- AE,urAmount of drug excreted via urineTimeframe: Day 0 to Day 4
- AE,ur(0-24)Amount of drug excreted into urine from 0 to 24 hours after administrationTimeframe: Day 0 to Day 4 and Day 10 to Day 14
- %AE,urRate of amount of drug excreted into urine to the administered doseTimeframe: Day 0 to Day 4
- %AE,ur(0-24)Rate of amount of drug excreted into urine from 0 to 24 hours after administration to the administered doseTimeframe: Day 0 to Day 4 and Day 10 to Day 14
- CLRRenal body clearance of drugTimeframe: Day 0 to Day 4 and Day 10 to Day 14
- Vz/FApparent volume of distribution during terminal phase after oral administrationTimeframe: Day 0 to Day 4
- PTFPeak trough fluctuationTimeframe: Day 10 to Day 14
- Accumulation ratio RACmaxAccumulation ratio calculated from Cmax after multiple dosing and Cmax after single dosingTimeframe: Day 10 compared to Day 4
- Accumulation ratio RAAUCAccumulation ratio calculated from AUCτ after multiple dosing and AUCτ after single dosingTimeframe: Day 10 compared to Day 4
Additional Information
Not Available
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