The Effect of Severe Kidney Impairment on Cenerimod Pharmacokinetics

Idorsia Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Renal Impairment; Healthy

Treatments: Drug: Cenerimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT05004311

2021-001522-21 (EudraCT Number)

ID-064-107

Details and patient eligibility

About

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

Enrollment: 16 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Group A (severe renal function impairment)

Experimental group

Description:

Eight (8) participants with severe renal impairment.

Treatment:

Drug: Cenerimod

Group B (healthy)

Experimental group

Description:

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

Treatment:

Drug: Cenerimod