check_circleStudy Completed
Leiomyoma
Bayer Identifier:
15251
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Effect of hepatic impairment on the pharmacokinetics, safety and tolerability of BAY1002670 (vilaprisan)
Trial purpose
Evaluate the potential effect of hepatic impairment on the pharmacokinetics, safety and tolerability of BAY1002670 (vilaprisan)
Key Participants Requirements
Sex
BothAge
18 - 79 YearsTrial summary
Enrollment Goal
36Trial Dates
March 2017 - July 2017Phase
Phase 1Could I Receive a placebo
NoProducts
Vilaprisan (BAY1002670)Accepts Healthy Volunteer
YesWhere to participate
Status | Institution | Location |
---|---|---|
Completed | CRS Clinical-Research-Services Kiel GmbH | Kiel, 24105, Germany |
Completed | Universitätsklinikum Schleswig-Holstein / AÖR | Lübeck, 23538, Germany |
Primary Outcome
- Area under the concentration vs. time curve in plasma from zero to infinity (AUCu) (unbound)Exposure of Vilaprisan in plasma following a single dose administrationdate_rangeTime Frame:At pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours and at 1, 2, 3, 7, 10, 13, 16, 20 daysenhanced_encryptionNoSafety Issue:
- Maximum observed (unbound) drug concentration (Cmax,u)Maximum observed (unbound) drug concentration (Cmax,u) in measured matrix after a single dose administrationdate_rangeTime Frame:At pre-dose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 hours and at 1, 2, 3, 7, 10, 13, 16, 20 daysenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Frequency of Treatment Emergent Adverse EventsFrequency of Treatment Emergent Adverse Events as a measure of safety and tolerabilitydate_rangeTime Frame:Up to 20 daysenhanced_encryptionYesSafety Issue:
- Severity of Treatment Emergent Adverse EventsThe intensity of an AE is classified according to the following categories: - Mild - Moderate - Severedate_rangeTime Frame:Up to 20 daysenhanced_encryptionYesSafety Issue:
- Changes in blood laboratory parametersChanges in blood laboratory parameters including hematology, clotting status, serum chemistrydate_rangeTime Frame:Up to 20 daysenhanced_encryptionYesSafety Issue:
- Changes in urine laboratory parametersChanges in urine laboratory parameters including urine analysis, urine pregnancy testsdate_rangeTime Frame:Up to 20 daysenhanced_encryptionYesSafety Issue:
- Changes in Vital SignsChanges in Vital Signs, including blood pressure, pulse, body temperaturedate_rangeTime Frame:Up to 20 daysenhanced_encryptionYesSafety Issue:
- Changes in Electrocardiogram (ECG)ECG (12-lead) after ≥10 minutes supine restdate_rangeTime Frame:Up to 20 daysenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
Non-randomizedBlinding
Open LabelAssignment
Parallel AssignmentTrial Arms
3