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Pharmacokinetics and Pharmacodynamics of Repository Corticotropin Injection Compared With Synthetic ACTH 1-24 Depot and Methylprednisolone in Healthy Subjects.
- Source :
-
Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2022 Apr; Vol. 11 (4), pp. 502-515. Date of Electronic Publication: 2021 Sep 15. - Publication Year :
- 2022
-
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 <subscript>1-24</subscript> depot. Methylprednisolone was included to estimate the steroidogenic exposure of RCI and synthetic ACTH <subscript>1-24</subscript> 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 <subscript>1-24</subscript> depot (1 mg subcutaneously twice weekly on study days 1 and 4), or methylprednisolone (32 mg orally once daily on study days 1 through 6). After 2 doses, RCI induced about 5-fold lower free cortisol exposure and an estimated 4-fold lower steroidogenic exposure than synthetic ACTH <subscript>1-24</subscript> depot. The lower endogenous cortisol response of RCI was achieved despite higher observed mean plasma concentrations of N25-deamidated porcine ACTH <subscript>1-39</subscript> (the pharmacokinetic marker for RCI) than of ACTH <subscript>1-24</subscript> . The different pharmacodynamic properties demonstrated by RCI and synthetic ACTH <subscript>1-24</subscript> depot in this study suggest that these products in the ACTH class are not interchangeable.<br /> (© 2021 Mallinckrodt Pharmaceuticals. Clinical Pharmacology in Drug Development published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology.)
Details
- Language :
- English
- ISSN :
- 2160-7648
- Volume :
- 11
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Clinical pharmacology in drug development
- Publication Type :
- Academic Journal
- Accession number :
- 34528408
- Full Text :
- https://doi.org/10.1002/cpdd.1020