Study to Evaluate the Safety and Tolerability of AMG 986 in Healthy Volunteers and Heart Failure Patients
NCT03276728 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 182
Last updated 2022-08-08
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).
Conditions
- Heart Failure
- Healthy Volunteer
Interventions
- 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
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
MD · Amgen
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2016-08-12
- Primary Completion
- 2019-04-18
- Completion
- 2019-04-18
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
- France
- Germany
- Netherlands
- New Zealand
- Poland
- Singapore
Study Locations
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