Pharmacokinetics and Pharmacodynamics of Repository Corticotropin Injection Compared With Synthetic ACTH_1-24 Depot and Methylprednisolone in Healthy Subjects.

ABSTRACT: Repository corticotropin injection (RCI; Acthar Gel) is a naturally sourced complex mixture of adrenocorticotropic hormone (ACTH) analogs and other pituitary peptides. This phase 1, single-center, open-label, randomized parallel study directly compared the pharmacokinetics and pharmacodynamics of RCI and synthetic ACTH_1-24 depot. Methylprednisolone was included to estimate the steroidogenic exposure of RCI and synthetic ACTH_1-24 depot when used to treat nephrotic syndrome. A total of 48 healthy subjects aged 18 to 50 years were randomly assigned 1:1:1 to RCI (80 IU subcutaneously twice weekly on study days 1 and 4), synthetic ACTH_1-24 depot (1 mg subcutaneously twice weekly on study days 1 and 4), or methylprednisolone (32 mg orally once daily on study days

SUBMITTER: Poola N 

PROVIDER: S-EPMC9290342 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature