Trial Condition(s):
Heart Failure
Multiple dose food effect Phase I study of BAY1021189
Bayer Identifier:
16440
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The primary objective of this study was to investigate the PK of BAY 1021189 after single oral doses of 1.25 mg, 2.5 mg, 5 mg and 10 mg administered as IR tablets in the fed state (high-fat, high-calorie breakfast).
The secondary objective of this study was to assess safety and tolerability of BAY 1021189.
Inclusion Criteria
- Healthy male subject - Age: 18 to 45 years (inclusive) at the first screening visit - Ethnicity: White - Body mass index (BMI): above/equal 18.0 and below/equal 29.9 kg/m²
Exclusion Criteria
- Incompletely cured pre-existing diseases for which it could be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs was not normal - Known hypersensitivity to the study drug (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 study drug administration - Febrile illness within 1 week before study drug administration - History of postural syncopes - Regular use of medicines - Regular use of therapeutic or recreational drugs (eg carnitin products, anabolics, high dose vitamins) - Use of medication within 2 weeks before study drug administration which could oppose the study objectives or which might influence them
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Köln, Germany, 51063 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Relative bioavailability study to investigate pharmacokinetics, safety and tolerability following administration of 1.25 mg, 2.5 mg, 5 mg and 10 mg BAY 1021189 as IR tablets following a high fat, high calorie meal in 16 healthy male subjects in a randomized, open label, fourfold crossover design
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
4
Primary Outcome
- Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose (AUC/D) of BAY1021189Timeframe: 0-72 hours (h)
- Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity Divided by Dose per Kilogram Body Weight (AUCnorm) of BAY1021189Timeframe: 0-72 h
- Maximum Drug Plasma Concentration Divided by Dose (Cmax/D) of BAY1021189Timeframe: 0-72 h
- Maximum Drug Plasma Concentration Divided by Dose per Kilogram Body Weight (Cmax,norm) of BAY1021189Timeframe: 0-72 h
- Number of Subjects With Treatmentemergent Adverse Events (TEAEs)Timeframe: From start of study treatment up to the end of followup visit (1 week after last dose)
- Number of Subjects With Clinically Relevant Time- or Dose-related Changes in Laboratory, Vital Signs and Electrocardiogram (ECG) ParametersTimeframe: From start of study treatment up to the end of followup visit (1 week after last dose)
Secondary Outcome
- Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC) of BAY1021189Timeframe: 0-72 h
- Maximum Drug Plasma Concentration (Cmax) of BAY1021189Timeframe: 0-72 h
- Time to Reach Maximum Drug Plasma Concentration (tmax) of BAY1021189Timeframe: 0-72 h
- Halflife Associated With the Terminal Slope (t1/2) of BAY1021189 in PlasmaTimeframe: 0-72 h
- Total Body Clearance of Drug from Plasma (CL/F) of BAY1021189Timeframe: 0-72 h
- Apparent Volume of Distribution During Terminal Phase (Vz/F) of BAY1021189 in PlasmaTimeframe: 0-72 h
- Area Under the Plasma Concentration Versus Time Curve From Zero to Last Data Point (AUC[0tlast]) of BAY1021189Timeframe: 0-72 h
- Area Under the Plasma Concentration Versus Time Curve From Zero to Last Data Point Divided by Dose per Kilogram Body Weight (AUC[0tlast] norm) of BAY1021189Timeframe: 0-72 h
- Mean Residence Time (MRT) of BAY1021189 in PlasmaTimeframe: 0-72 h
Additional Information
Not Available
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