{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["22(2)"],"submitter":["Trivedi A"],"funding":["Amgen"],"pubmed_abstract":["<h4>Background and objective</h4>AMG 986 is a first-in-class, novel apelin receptor small molecule agonist initially developed for the treatment of heart failure. The current phase I study was conducted to evaluate the pharmacokinetics and safety of a single-dose 200-mg capsule formulation of AMG 986 relative to the tablet formulation in 12 healthy subjects.<h4>Methods</h4>In a two-period, two-way crossover design, eligible subjects were randomized 1:1 to tablet/capsule or capsule/tablet treatment sequences; each treatment sequence lasted for approximately 6 days and comprised six subjects.<h4>Results</h4>Following a single oral dose of AMG 986, the geometric mean maximum observed concentration (C<sub>max</sub>) values were 9670 ng/mL and 6920 ng/mL and the geometric mean area under the cu"],"journal":["Drugs in R&D"],"pagination":["147-154"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9167409"],"repository":["biostudies-literature"],"pubmed_title":["Evaluation of the Pharmacokinetics and Safety of AMG 986 Tablet and Capsule Formulations in Healthy Adult Subjects: A Phase I, Open-Label, Randomized Study."],"pmcid":["PMC9167409"],"pubmed_authors":["Trivedi A","Hellawell J","Saw RE","Mather O","Kiang YH","Vega S","Cheng GC","Lee E"],"additional_accession":[]},"is_claimable":false,"name":"Evaluation of the Pharmacokinetics and Safety of AMG 986 Tablet and Capsule Formulations in Healthy Adult Subjects: A Phase I, Open-Label, Randomized Study.","description":"<h4>Background and objective</h4>AMG 986 is a first-in-class, novel apelin receptor small molecule agonist initially developed for the treatment of heart failure. The current phase I study was conducted to evaluate the pharmacokinetics and safety of a single-dose 200-mg capsule formulation of AMG 986 relative to the tablet formulation in 12 healthy subjects.<h4>Methods</h4>In a two-period, two-way crossover design, eligible subjects were randomized 1:1 to tablet/capsule or capsule/tablet treatment sequences; each treatment sequence lasted for approximately 6 days and comprised six subjects.<h4>Results</h4>Following a single oral dose of AMG 986, the geometric mean maximum observed concentration (C<sub>max</sub>) values were 9670 ng/mL and 6920 ng/mL and the geometric mean area under the cu","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Jun","modification":"2026-05-10T01:38:42.622Z","creation":"2025-02-19T01:12:16.128Z"},"accession":"S-EPMC9167409","cross_references":{"pubmed":["35412220"],"doi":["10.1007/s40268-022-00388-1"]}}