Spots Global Cancer Trial Database for Pharmacokinetics and Safety of Vilaprisan in Renal Impairment
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Trial Identification
Brief Title: Pharmacokinetics and Safety of Vilaprisan in Renal Impairment
Official Title: 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
Study ID: NCT03411980
Interventions
Study Description
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
Clinical Pharmacology of Miami, Inc., Miami, Florida, United States
Orlando Clinical Research Center, Orlando, Florida, United States
Contact Details
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