Study Completed

Uterine fibroids, Endometriosis

Bayer Identifier:

16524

ClinicalTrials.gov Identifier:

NCT03411980

EudraCT Number:

Not Available

EU CT Number:

Not Available

Pharmacokinetics and safety of vilaprisan in renal impairment

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.

Key Participants Requirements

Sex

All

Age

18 - 79 Years

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

Trial Dates

February 2018 - February 2019

Phase

Phase 1

Could I Receive a placebo

Products

Vilaprisan (BAY1002670)

Accepts Healthy Volunteer

Yes

Where to participate

Status	Institution	Location
Completed	Clinical Pharmacology of Miami, Inc.	Miami, 33014, United States
Completed	Orlando Clinical Research Center	Orlando, 32809, United States

Primary Outcome

Area under the concentration versus time curve from zero to infinity after single (first) dose (AUC) of BAY1002670
Area 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.
Time Frame:
-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 BAY1002670
In subjects with normal and moderately reduced renal function.
Time Frame:
-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 events
In subjects with normal, moderately, and severely reduced renal function.
Time Frame:
Up to 6 weeks
AUC
In subjects with normal, moderately, and severely reduced renal function.
Time Frame:
-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.
Time Frame:
-1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d
Cmax
In subjects with normal, moderately, and severely reduced renal function.
Time Frame:
-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.
Time Frame:
-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.
Time Frame:
-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.
Time Frame:
-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.
Time Frame:
-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.
Time Frame:
-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.
Time Frame:
-1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d

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

Additional Information

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