Pharmacokinetics and Safety of Vilaprisan in Renal Impairment

NCT03411980 | Completed Phase 1 FDA Drug

• 1 other identifier: 16524
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

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.

Conditions

Uterine Fibroids; Endometriosis

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• 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.

  -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.

  -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d

Secondary Outcomes (10)

• Number of participants with adverse events

  Up to 6 weeks

• AUC

  -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d

• unbound AUC (AUCu)

  -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d

• Cmax

  -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)

  -1h, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 12h ,16h, 1d, 2d, 3d, 4d, 7d, 10d, 14d

Study Arms (3)

Subjects with moderately decreased renal function

EXPERIMENTAL

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.

Drug: Vilaprisan (BAY1002670)

Subjects with severely decreased renal function

EXPERIMENTAL

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

Drug: Vilaprisan (BAY1002670)

Control subjects with normal renal function

EXPERIMENTAL

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

Drug: Vilaprisan (BAY1002670)

Interventions

Vilaprisan (BAY1002670) DRUG

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

Control subjects with normal renal function; Subjects with moderately decreased renal function; Subjects with severely decreased renal function

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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%.

Sponsors & Collaborators

• Bayer: lead

Study Sites (2)

Clinical Pharmacology of Miami, Inc.

Miami, Florida, 33014, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Related Links

• Click here to find results for studies related to Bayer products

MeSH Terms

Conditions

Leiomyoma; Endometriosis

Interventions

vilaprisan

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 26, 2018
• Study Start: February 2, 2018
• Primary Completion: October 10, 2018
• Study Completion: February 6, 2019
• Last Updated: December 3, 2019

Record last verified: 2019-12

Locations

US (2)