Effect of Renal Impairment on Enpatoran Pharmacokinetics

Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study ID
NCT06589713
Phase
PHASE1
Status
Completed

Conditions

  • Renal Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Enpatoran — DRUG
    Participants will receive a single oral dose of enpataron tablets once daily.

Study Details

The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics of enpatoran.

Key Dates

Start date
Sep 24, 2024
Status verified
Apr 2026
Primary completion
Apr 13, 2026
Completion
Apr 13, 2026

Study Design

Enrollment
34 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Control Group 1 (Normal Renal Function)
  • Experimental: Group 2 (Impaired Renal Function)

Primary Outcome Measure

Pharmacokinetic (PK) Plasma Concentrations of Enpatoran [ Time Frame: Predose, 0.5, 1, 1.5, 2, 4, 8, 12, 24, 36, and 48 hours postdose ]

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