Pharmacokinetics and Safety of Vilaprisan in Renal Impairment

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 regard to sex, age, race and weight. PK blood and urine sampling for
determination of vilaprisan concentrations in plasma and urine, respectively, will be
preformed at pre-defined time points up to 14 days post-dose. Safety and tolerability will be
assessed through adverse events, clinical laboratory tests, vital signs, 12-lead
electrocardiograms and physical examinations.

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%.