The Effect of Severe Kidney Impairment on Cenerimod Pharmacokinetics

An Open-label, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cenerimod After Single-dose Administration in Subjects With Severe Renal Impairment and Control Subjects

To investigate the PK of cenerimod in participants with severe renal impairment as compared to healthy control participants.

Study Overview

• Status: Completed
• Conditions: Healthy; Renal Impairment
• Intervention / Treatment: Drug: Cenerimod

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• Portugal
  • Porto, Portugal, 4250-449
    • BlueClinical Phase 1 Hospital de Prelado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (severe renal function impairment); Eight (8) participants with severe renal impairment.	Drug: Cenerimod; 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; Other Names: ACT-334441
Experimental: Group B (healthy); Eight (8) control participants, matched to the 8 severe renal impaired participants enrolled in Group A.	Drug: Cenerimod; 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; Other Names: ACT-334441

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Apparent oral clearance (CL/F) 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 Outcome Measures

Outcome Measure	Time Frame
Total lymphocyte count count.	Total duration: up to 66 days
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

Collaborators and Investigators

• Sponsor: Viatris Innovation GmbH
• Investigators: Study Director: Clinical Trials, Viatris Innovation GmbH

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2021
• Primary Completion (Actual): July 27, 2023
• Study Completion (Actual): August 10, 2023

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 5, 2021
• First Posted (Actual): August 13, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; cenerimod
• Other Study ID Numbers: ID-064-107; 2021-001522-21 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No