NCT05004311

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2021

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 13, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 27, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2023

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2023

Completed
Last Updated

September 22, 2025

Status Verified

August 1, 2023

Enrollment Period

1.8 years

First QC Date

August 3, 2021

Last Update Submit

September 16, 2025

Conditions

HealthyRenal Impairment

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (5)

  • 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

Study Arms (2)

Group A (severe renal function impairment)

EXPERIMENTAL

Eight (8) participants with severe renal impairment.

Drug: Cenerimod

Group B (healthy)

EXPERIMENTAL

Eight (8) control participants, matched to the 8 severe renal impaired participants enrolled in Group A.

Drug: Cenerimod

Interventions

CenerimodDRUG

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

Also known as: ACT-334441
Group A (severe renal function impairment)Group B (healthy)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BlueClinical Phase 1 Hospital de Prelado

Porto, 4250-449, Portugal

Location

MeSH Terms

Conditions

Renal Insufficiency

Interventions

cenerimod

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Clinical Trials

    Viatris Innovation GmbH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2021

First Posted

August 13, 2021

Study Start

September 27, 2021

Primary Completion

July 27, 2023

Study Completion

August 10, 2023

Last Updated

September 22, 2025

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)