NCT03276728

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

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 986 in Healthy Subjects and Heart Failure Patients

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

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).

Detailed description

This study is a randomized, placebo-controlled, double-blind, single day ascending dose (SDAD) study (Part A), a multiple daily ascending dose (MDAD) study (Part B), in healthy adults, and a MDAD study (Part C) in heart failure patients. In Parts A and B of the study, healthy volunteers will receive AMG 986 by continuous IV infusion or by oral administration in a fasted state. IV Infusions will be divided into an initial loading dose (LD) for the first hour followed immediately by a maintenance dose (MD). In Part C of the study, patients with heart failure and either reduced (HFrEF) or preserved (HFpEF) ejection fraction will receive MDAD of AMG 986 or matching placebo once daily by oral administration for 21 days.

Conditions

• Heart Failure
• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	AMG 986 IV	AMG 986 solution for infusion
DRUG	AMG 986 PO	AMG 986 tablets for oral (PO) administration
DRUG	Placebo PO	Matching placebo tablets for oral administration
DRUG	Placebo IV	Matching placebo solution for infusion

Timeline

• Start date: 2016-08-12
• Primary completion: 2019-04-18
• Completion: 2019-04-18
• First posted: 2017-09-08
• Last updated: 2022-08-08
• Results posted: 2022-08-08

Locations

25 sites across 9 countries: United States, Australia, Canada, France, Germany, Netherlands, New Zealand, Poland, Singapore

Regulatory

• FDA-regulated drug study