Pharmacokinetics and Safety of Vilaprisan in Renal Impairment

NCT ID: NCT03411980

Last Updated: 2019-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-02
• Study Completion Date: 2019-02-06

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 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.

Conditions

Uterine Fibroids; Endometriosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Subjects with moderately decreased renal function

Subjects with moderate renal impairment with an estimated glomerular filtration rate (eGFR) of 30 to 59 mL/min/1.73 m\*2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.

Group Type: EXPERIMENTAL

Vilaprisan (BAY1002670)

Intervention Type: DRUG

Single oral dose (1 x 2 mg immediate-release, film-coated tablet)

Subjects with severely decreased renal function

Subjects with severe renal impairment not on dialysis with an eGFR \<30 mL/min/1.73 m\*2 (CKD-EPI formula).

Group Type: EXPERIMENTAL

Vilaprisan (BAY1002670)

Intervention Type: DRUG

Single oral dose (1 x 2 mg immediate-release, film-coated tablet)

Control subjects with normal renal function

Subjects with an eGFR ≥90 mL/min/1.73 m\*2 (CKD-EPI formula) who are matched based on sex, age, race and weight.

Group Type: EXPERIMENTAL

Vilaprisan (BAY1002670)

Intervention Type: DRUG

Single oral dose (1 x 2 mg immediate-release, film-coated tablet)

Interventions

Vilaprisan (BAY1002670)

Single oral dose (1 x 2 mg immediate-release, film-coated tablet)

Intervention Type: DRUG

Eligibility Criteria

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%.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Pharmacology of Miami, Inc.

Miami, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Countries

United States

Related Links

http://clinicaltrials.bayer.com/

Click here to find results for studies related to Bayer products

Other Identifiers

16524

Identifier Type: -

Identifier Source: org_study_id