Why the study?
The safety and pharmacokinetics of AMG 986, an apelin receptor agonist for heart failure, remained unknown in participants with renal impairment.
Does severe renal impairment affect the safety, tolerability, and pharmacokinetics of a single oral dose of AMG 986 compared to normal renal function?
Does severe renal impairment affect the safety, tolerability, and pharmacokinetics of a single oral dose of AMG 986 compared to normal renal function?
The pharmacokinetics of AMG 986 are minimally affected by severe renal impairment, supporting its evaluation in heart failure patients with renal impairment without the need for dose adjustments.
Supports further AMG 986 development in HF with RI; leaves open dedicated efficacy and safety trials.
INTRODUCTION: AMG 986 is a first-in-class, novel apelin receptor small molecule agonist initially developed for the treatment of heart failure (HF). The safety and pharmacokinetics (PK) of AMG 986 in participants with renal impairment (RI) remains unknown. METHODS: ). RESULTS: Following a single oral dose of AMG 986 200 mg on day 1, the maximum observed concentration increased 1.41-fold (90% confidence interval [CI] 0.88-2.27) and the area under the curve from time zero to infinity increased 1.23-fold (90% CI 0.73-2.06) in participants with severe RI versus normal renal function. AMG 986 had an acceptable safety profile; all adverse events were mild in severity. CONCLUSIONS: The results of this study support the enrollment of HF patients with RI to clinical trials of AMG 986 without the need for dose adjustments. TRIAL REGISTRATION NUMBER: NCT03318809 (registered: October 24, 2017).
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Trivedi et al. (2022) studied this question.
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