The Effect of Severe Kidney Impairment on Cenerimod Pharmacokinetics
- Registration Number
- NCT05004311
- Lead Sponsor
- Idorsia Pharmaceuticals Ltd.
- Brief Summary
To investigate the PK of cenerimod in participants with severe renal impairment as compared to healthy control participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
- Signed informed consent in a language understandable to the participant prior to any study-mandated procedure.
- Women of childbearing potential must have a negative serum pregnancy test at screening, a negative urine pregnancy test on Day -1, and agree to consistently and correctly use a highly effective method of contraception.
- Women of non-childbearing potential.
- Body mass index of 18.0 to 35.0 kg/m2 (inclusive) at Screening
- Negative SARS-CoV-2 reverse transcription polymerase chain reaction test on Day -1.
Additional inclusion criteria for participants with severe renal impairment
- Estimated glomerular filtration rate (eGFR) at screening using the Modification of Diet in Renal Disease formula less-than 30 mL/min/1.73 m2 for participants with renal impairment. The eGFR value should be confirmed on Day -1.
- Systolic blood pressure (SBP) 100 to 180 mmHg, diastolic BP (DBP) 50 to 105 mmHg, and pulse rate 60 to 100 bpm (inclusive), on Day 1 pre-dose.
- Stable concomitant medications for at least 3 weeks prior to screening and up to Day 1.
- Aspartate aminotransferase and alanine aminotransferase above the upper limit of normal.
- Clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry, and urinanalysis) except for those related to renal impairment at Screening and on Day-1.
Additional inclusion criteria for control participants
- eGFR at Screening using the Modification of Diet in Renal Disease formula of ≥ 90 mL/min/1.73 m2.
- SBP 90 to 139 mmHg, DBP 60 to 89 mmHg, and pulse rate 60 to 99 bpm, measured on the same arm, after 5 min in the supine position at screening and on Day 1 pre-dose.
Exclusion Criteria
- Pregnant or lactating women.
- Participation in a clinical study involving study treatment administration within 3 months prior to screening or participation in more than 2 clinical studies within 1 year prior to Screening.
- Previous exposure to cenerimod.
- Known hypersensitivity to any excipients of the treatment formulation.
- Clinically relevant abnormalities on a 12-lead electrocardiogram at Screening and Day -1.
- Previous treatment with anti-arrhythmic medications of class Ia or III within 2 weeks or 5 half-lives, whichever is longer, prior to study treatment administration.
- History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatment except for renal disease, appendectomy, herniotomy, or cholecystectomy.
- Aspartate aminotransferase and alanine aminotransferase above the upper limit of normal.
- Legal incapacity or limited legal capacity at Screening.
Additional exclusion criteria for participants with severe renal impairment:
- Presence of severe cardiac disease.
- End-stage renal disease that requires dialysis.
- History of severe renal artery stenosis.
- Serum potassium concentration > 5.5 mmol/L.
- Presence of unstable diabetes mellitus.
- Strict fluid restriction.
- Clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry, and urinalysis) except for those related to renal impairment at Screening and on Day -1.
Additional exclusion criteria for control participants
- Clinically relevant findings on the physical examination at Screening.
- Clinically relevant findings in clinical laboratory tests.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group B (healthy) Cenerimod Eight (8) control participants, matched to the 8 severe renal impaired participants enrolled in Group A. Group A (severe renal function impairment) Cenerimod Eight (8) participants with severe renal impairment.
- Primary Outcome Measures
Name Time Method The time to reach Cmax (tmax) of cenerimod Total duration: up to 52 days Extent of cenerimod protein plasma binding (PPB) Total duration: up to 52 days The maximum plasma concentration (Cmax) of cenerimod Total duration: up to 52 days Area under the plasma concentration-time curve (AUC from 0 to infinity) of cenerimod Total duration: up to 52 days Apparent volume of distribution (Vz/F) of cenerimod Total duration: up to 52 days Area under the plasma concentration-time curve (AUC) from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t) of cenerimod Total duration: up to 52 days Terminal half-life (t½) of cenerimod Total duration: up to 52 days Apparent oral clearance (CL/F) of cenerimod Total duration: up to 52 days
- Secondary Outcome Measures
Name Time Method Change from baseline at each time point of measurement in electrocardiogram QT interval Total duration: up to 66 days Change from baseline in body weight Total duration: up to 66 days Incidence of abnormal laboratory test results Total duration: up to 66 days Change from baseline in systolic and diastolic blood pressure (in the supine position) Total duration: up to 66 days Total lymphocyte count count. Total duration: up to 66 days
Trial Locations
- Locations (1)
BlueClinical Phase 1 Hospital de Prelado
🇵🇹Porto, Portugal