Trial Condition(s):

Uterine Fibroids, Endometriosis

Pharmacokinetics and safety of vilaprisan in renal impairment

Bayer Identifier:

16524

ClinicalTrials.gov Identifier:

NCT03411980

EudraCT 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
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Phase
1
Could I receive a placebo?
No
Products
Vilaprisan (BAY1002670)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Clinical Pharmacology of Miami, Inc.

Miami, United States, 33014

Status
Completed
 
Locations

Orlando Clinical Research Center

Orlando, United States, 32809

Status
Completed
 

Trial Design