Healthy, Renal Impairment
Conditions
Brief summary
To investigate the PK of cenerimod in participants with severe renal impairment as compared to healthy control participants.
Interventions
DRUGCenerimod
A single oral dose of 0.5 mg cenerimod will be administered as a film-coated tablet in the morning of Day 1 under fasted conditions
Sponsors
Viatris Innovation GmbH
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apparent oral clearance (CL/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 |
| Area under the plasma concentration-time curve (AUC from 0 to infinity) of cenerimod | Total duration: up to 52 days |
| The maximum plasma concentration (Cmax) of cenerimod | Total duration: up to 52 days |
| The time to reach Cmax (tmax) of cenerimod | Total duration: up to 52 days |
| Terminal half-life (t½) of cenerimod | Total duration: up to 52 days |
| Extent of cenerimod protein plasma binding (PPB) | Total duration: up to 52 days |
| Apparent volume of distribution (Vz/F) of cenerimod | Total duration: up to 52 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change from baseline in systolic and diastolic blood pressure (in the supine position) | Total duration: up to 66 days |
| Incidence of abnormal laboratory test results | Total duration: up to 66 days |
| Total lymphocyte count count. | Total duration: up to 66 days |
Countries
Portugal
Outcome results
None listed