Status:
COMPLETED
Pharmacokinetics and Safety of Vilaprisan in Renal Impairment
Lead Sponsor:
Bayer
Conditions:
Uterine Fibroids
Endometriosis
Eligibility:
All Genders
18-79 years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
This is a multiple-center, open-label, non-randomized, single-dose study in 3 parallel groups of subjects with moderately or severely impaired renal function or normal renal function matched with rega...
Eligibility Criteria
Inclusion
- 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
- 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%.
Key Trial Info
Start Date :
February 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 6 2019
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT03411980
Start Date
February 2 2018
End Date
February 6 2019
Last Update
December 3 2019
Active Locations (2)
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1
Clinical Pharmacology of Miami, Inc.
Miami, Florida, United States, 33014
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809