Study to Evaluate the Safety and Tolerability of AMG 986 in Healthy Volunteers and Heart Failure Patients

Phase 1 Terminated 182 enrolled Amgen

RandomizedParallel-groupDouble-blindTreatment

Summary

To evaluate the safety and tolerability of ascending single (Part A) and ascending multiple (Part B) doses of AMG 986 in healthy adults and of ascending multiple oral doses of AMG 986 in heart failure patients (Part C).

Timeline

Start: 2016-08-12
Primary completion: 2019-04-18
Completion: 2019-04-18

Outcome

Outcome not reported

Stopped: “Terminated (Decision by the Sponsor. The study was not terminated due to a safety reason.)”

Publications

Winkle P, Goldsmith S, Koren MJ, Lepage S, Hellawell J, Trivedi A, Tsirtsonis K, Abbasi SA, Kaufman A, Troughton R, Voors A, Hulot JS, Donal E, Kazemi N, Neutel J. A First-in-Human Study of AMG 986, a Novel Apelin Receptor Agonist, in Healthy Subjects and Heart Failure Patients. Cardiovasc Drugs Ther. 2023 Aug;37(4):743-755. doi: 10.1007/s10557-022-07328-w. Epub 2022 Apr 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AMG 986	Unknown	0.5 mg	Intravenous
Subject	AMG 986	Unknown	5 mg	Intravenous
Subject	AMG 986	Unknown	38 mg	Intravenous
Subject	AMG 986	Unknown	100 mg	Intravenous
Subject	AMG 986	Unknown	360 mg	Intravenous
Subject	AMG 986	Unknown	376 mg	Intravenous
Subject	AMG 986	Unknown	650 mg	Intravenous