Trial Condition(s):
Clinical Pharmacology
An Exploratory Phase I, Randomized, Open Label Two Fold Cross-Over Study to Determine the Effect of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of 1.25 mg BAY 1021189 in Healthy Male Subjects
Bayer Identifier:
15812
ClinicalTrials.gov Identifier:
Not Available
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The primary objective is to investigate the influence of multiple doses of 200 milligram (mg) ketoconazole twice daily, on the pharmacokinetics (PK) of BAY1021189 given as a single oral dose of 1.25 mg in comparison to a single oral dose of 1.25 mg BAY1021189 alone.
Inclusion Criteria
- Healthy male subject - Age: 18 to 45 years (inclusive) at the 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 can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal - Known hypersensitivity to the study drug (active substances or excipients of the preparations) or to any imidazole containing antifungal - 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 - Intake of foods or beverages containing grapefruit within 2 weeks before the first study drug administration - Donation of blood of approximately 500 mL or plasmapheresis within 3 months before study drug administration - Donation of more than 100 mL of blood within 4 weeks before 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 Berlin, Germany, 13353 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
An Exploratory Phase I, Randomized, Open Label Two Fold Cross-Over Study to Determine the Effect of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of 1.25 mg BAY 1021189 in Healthy Male Subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
Randomized
Blinding:
N/A
Assignment:
N/A
Trial Arms:
2
Primary Outcome
- Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC) of BAY1021189Timeframe: PK samples were taken between 0 to 72 hours
- Maximum Observed Drug Concentration (Cmax) of BAY1021189Timeframe: PK samples were taken between 0 to 72 hours
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs)Timeframe: From start of study treatment up to the last followup visit (within 12 weeks after last dose)
- Number of Subjects With Clinically Relevant Changes in Laboratory, Vital Signs and Electrocardiogram (ECG) ParametersTimeframe: From start of study treatment up to the last followup visit (within 12 weeks after last dose)
Secondary Outcome
- Area Under the Plasma Concentration Versus Time Curve From Zero to Last Data Point (AUC[0tlast]) of BAY1021189Timeframe: PK samples were taken between 0 to 72 hours
- 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: PK samples were taken between 0 to 72 hours
- Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours (AUC[024]) of BAY1021189Timeframe: PK samples were taken between 0 to 24 hours
- Area Under the Plasma Concentration Versus Time Curve From Zero to 24 Hours Divided by Dose per Kilogram Body Weight (AUC[024], norm) of BAY1021189Timeframe: PK samples were taken between 0 to 24 hours
- Maximum Observed Drug Concentration Divided by Dose per Kilogram Body Weight (Cmax,norm) of BAY1021189Timeframe: PK samples were taken between 0 to 72 hours
- Time to Reach Maximum Drug Plasma Concentration (tmax) of BAY1021189Timeframe: PK samples were taken between 0 to 72 hours
- Half-life Associated With the Terminal Slope (t1/2) of BAY1021189 in PlasmaTimeframe: PK samples were taken between 0 to 72 hours
- Total Body Clearance of Drug from Plasma (CL/F) of BAY1021189Timeframe: PK samples were taken between 0 to 72 hours
- Apparent Volume of Distribution During Terminal Phase (Vz/F) of BAY1021189 in PlasmaTimeframe: PK samples were taken between 0 to 72 hours
- Mean Residence Time (MRT) of BAY1021189 in PlasmaTimeframe: PK samples were taken between 0 to 72 hours
- Percentage (%) of Amount of Renal Excretion (%AEur) of BAY1021189Timeframe: Urine collection: 0 to 72 hours
- Amount of Renal Excretion (AEur in milligram) of BAY1021189Timeframe: Urine collection: 0 to 72 hours
- Renal Body Clearance (CLR) of BAY1021189Timeframe: Urine collection: 0 to 72 hours
Additional Information
Not Available
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