Effect of Renal Impairment on Enpatoran Pharmacokinetics (NCT06589713) | Clinical Trial Compass
CompletedPhase 1
Effect of Renal Impairment on Enpatoran Pharmacokinetics
Germany34 participantsStarted 2024-09-24
Plain-language summary
The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics of enpatoran.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
For Control Group 1 (Normal Renal Function):
* Medical history and physical examination without any ongoing clinically relevant findings as judged by the Investigator
* No clinically relevant findings (only minor deviations) in biochemistry, hematology, coagulation, and urinalysis examinations for the age of the participant, as judged by the Investigator; absolute lymphocyte count and absolute neutrophil count must be within normal limits
For Group 2 (Impaired Renal Function):
* Medical history and physical examination without any ongoing clinically relevant findings except for the underlying disease leading to renal impairment and consequence diseases thereof
* Chronic kidney disease
* For participants under medication, stable medication for at least 1 month
* Other protocol defined inclusion criteria could apply
Exclusion Criteria:
* History or presence of respiratory, gastrointestinal (including bariatric or other gastric surgeries, or other conditions that may affect drug absorption), hepatic (including hepatorenal syndrome), hematological, lymphatic, cardiovascular (such as ventricular dysfunction and congestive heart failure, cardiac arrythmia), psychiatric, neurological, genitourinary, immunological, dermatological, connective tissue diseases, or disorders that may affect the safety of the participant.
* History of drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredi…
What they're measuring
1
Pharmacokinetic (PK) Plasma Concentrations of Enpatoran