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AMG 986

Phase 1

Heart Failure | Small molecule | Cardiovascular |Amgen Inc.|Last Updated: Jun 23, 2022

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

AMG 986 · 1 trial · 1 indication

Phase 1 1
NCT03318809Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 986 Administered Orally to Healthy Volunteers and Participants With Severely Impaired Renal FunctionHeart Failure
COMPLETED12 Analytics
PHASE1COMPLETED
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 986 Administered Orally to Healthy Volunteers and Participants With Severely Impaired Renal Function
Heart FailureUnlock trial analytics

Study Endpoints

Primary Endpoints

AMG 986 Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Sample (AUClast)
Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
AMG 986 PK Parameter: Maximum Observed Plasma Concentration After Dosing (Cmax)
1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
AMG 986 PK Parameter: Terminal Phase Half-Life (t1/2,z)
Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
AMG 986 PK Parameter: Time of Maximum Plasma Concentration (Tmax)
Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
AMG 986 PK Parameter: Area Under the Plasma Concentration Time Curve From Time 0 to Infinity (AUCinf)
Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose

Secondary Endpoints

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
From first dose of study drug up to Day 30
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1: Severely Renal Impaired ParticipantsEXPERIMENTALParticipants with severely impaired renal function (estimated glomerular filtration rate \[eGFR\] 15 to 29 mL/min/1.73 m\^2) receive a single oral dose of 200 mg AMG 986.
Group 2: Healthy ParticipantsACTIVE_COMPARATORParticipants with normal renal function (eGFR \>= 90 mL/min/1.73 m\^2 or above) receive a single oral dose of 200 mg AMG 986.

Interventions

NameTypeDescription
AMG 986DRUGtablets for oral administration
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Male or female subjects, who are \> or = 18 and \< or = 65 years of age at the time of screening * Subject has provided informed consent prior to initiation of any study-specific activities/procedures * Women must be of non-reproductive potential (ie, postmenopausal, history o...

Countries:United States
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Frequently asked questions about AMG 986

What is AMG 986 used for?

AMG 986 is an investigational small molecule being developed by Amgen Inc. for the treatment of heart failure. It is currently in Phase 1 clinical development, meaning it is still being studied and has not been approved for use.

Who makes AMG 986?

AMG 986 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The drug is currently in Phase 1 clinical trials for heart failure.

What phase is AMG 986 in?

AMG 986 is in Phase 1 clinical development. It is an investigational drug for heart failure and has not been approved by regulatory authorities. The drug is still being studied for safety, tolerability, and pharmacokinetics.

What clinical trials is AMG 986 in?

AMG 986 has one completed Phase 1 clinical trial, identified as NCT03318809. This study evaluated the safety, tolerability, and pharmacokinetics of AMG 986 administered orally to healthy volunteers and participants with severely impaired renal function in the United States.

Is AMG 986 FDA approved?

AMG 986 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for heart failure. The drug is still being studied and has not been approved for any use.