Trial Condition(s):
Uterine Fibroids, Endometriosis
Pharmacokinetics and safety of vilaprisan in renal impairment
Bayer Identifier:
16524
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
The purpose of the study is to evaluate the pharmacokinetics of vilaprisan in subjects with moderate to severe renal impairment compared with matched subjects with normal renal function.
Inclusion Criteria
- BMI: 18 to 40 kg/m*2 (inclusive) - Decreased renal function, as assessed at screening, based on serum creatinine and calculated according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula, either: Moderately impaired renal function: eGFR: 30 to 59 mL/min/1.73 m*2; or Severely impaired renal function: eGFR <30 mL/min/1.73 m*2 but not on dialysis - Normal renal function, as assessed at screening and based on serum creatinine according to the CKD-EPI formula: eGFR ≥90 mL/min/1.73 m*2
Exclusion Criteria
-Any relevant disease within 4 weeks prior to study drug administration including infections and acute gastrointestinal diseases (vomiting, diarrhea, constipation) requiring medical treatment. - Severe cerebrovascular or cardiac disorders less than 6 months prior to study drug administration, e.g. stroke, myocardial infarction, unstable angina pectoris, percutaneous transluminal coronary angioplasty or coronary artery bypass graft, congestive heart failure of Grade III or IV according to New York Heart Association, or arrhythmia requiring antiarrhythmic treatment. - Malignancy diagnosed or treated within the past 5 years. This does not include adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin. - Acute renal failure or acute nephritis within the past 2 years. - Pregnancy or lactation. - Use of CYP3A4 inducers from 2 weeks before study drug administration until last day of blood sampling for PK after study drug administration, including grapefruits. - Insufficiently controlled diabetes mellitus with fasting blood glucose >220 mg/dL or HbA1c >10%.
Trial Summary
Enrollment Goal
26
Trial Dates
Phase
1
Could I receive a placebo?
No
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteers
Yes
Where to Participate
Loading...
Locations
| Locations | |
|---|---|
Locations Clinical Pharmacology of Miami, Inc. Miami, United States, 33014 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Orlando Clinical Research Center Orlando, United States, 32809 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
An open-label, single-dose study to evaluate the pharmacokinetics and safety of vilaprisan in subjects with decreased renal function in comparison with matched subjects with normal renal function
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Non-randomized
Blinding:
N/A
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of BAY1002670Area under the concentration versus time curve from zero to the last data point above the lower limit of quantitation [AUC(0-tlast)], if AUC cannot be estimated in all subjects. In subjects with normal and moderately reduced renal function.Timeframe: -1hour (h), 30minutes (min), 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1day (d), 2d, 3d, 4d, 7d, 10d, 14d
- Maximum observed drug concentration in measured matrix after single dose administration (Cmax) of BAY1002670In subjects with normal and moderately reduced renal function.Timeframe: -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d
Secondary Outcome
- Number of participants with adverse eventsIn subjects with normal, moderately, and severely reduced renal function.Timeframe: Up to 6 weeks
- AUCIn subjects with normal, moderately, and severely reduced renal function.Timeframe: -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d
- unbound AUC (AUCu)In subjects with normal, moderately, and severely reduced renal function.Timeframe: -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d
- CmaxIn subjects with normal, moderately, and severely reduced renal function.Timeframe: -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d
- Unbound Cmax (Cmax,u)In subjects with normal, moderately, and severely reduced renal function.Timeframe: -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d
- Apparent oral clearance (CL/F)In subjects with normal, moderately, and severely reduced renal function.Timeframe: -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d
- Unbound CL/F (CLu/F)In subjects with normal, moderately, and severely reduced renal function.Timeframe: -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d
- Half-life associated with the terminal slope (t1/2)In subjects with normal, moderately, and severely reduced renal function.Timeframe: -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d
- Renal clearance (CLR)In subjects with normal, moderately, and severely reduced renal function.Timeframe: -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d
- Fraction of free (unbound) drug in plasma (fu)In subjects with normal, moderately, and severely reduced renal function.Timeframe: -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d
Additional Information
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