Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AMG 986 Administered Orally to Healthy Volunteers and Participants With Severely Impaired Renal Function

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-12

Study Completion Date

2018-04-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

A study to assess the safety, tolerability, and pharmacokinetics of AMG 986 given orally as a single dose to healthy participants and participants with severely impaired kidney function.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03276728

Heart Failure Healthy Volunteer

TERMINATED PHASE1

A Study of Experimental Medication BMS-986231 in Patients With Different Levels of Kidney Function

NCT03332186

Myocardial Failure Cardiac Failure Congestive Heart Failure +2 more

COMPLETED PHASE1

An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired Participants

NCT03634969

Cardiac Failure Myocardial Failure

COMPLETED PHASE1

A Pharmacokinetics, Safety and Tolerability Study of Multiple Formulations of BMS-986231 in Healthy Participants

NCT03891108

Heart Failure

COMPLETED PHASE1

A Study to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of an Intravenous Solution of JNJ-39588146 or Placebo in Patients With Heart Failure

NCT01120210

Heart Failure

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This is a multisite (approximately 3 sites), open-label, non-randomized, single-dose study in participants with severely impaired kidney function and healthy participants. About 12 participants will be assigned to two groups: Group 1: 6 with severely impaired kidney function , and Group 2: 6 with normal kidney function.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

The patient, investigator, investigative staff, medical monitor and care provider will not be masked for the study.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1: Severely Renal Impaired Participants

Participants 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 Type EXPERIMENTAL

AMG 986

Intervention Type DRUG

tablets for oral administration

Group 2: Healthy Participants

Participants with normal renal function (eGFR \>= 90 mL/min/1.73 m\^2 or above) receive a single oral dose of 200 mg AMG 986.

Group Type ACTIVE_COMPARATOR

AMG 986

Intervention Type DRUG

tablets for oral administration

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

AMG 986

tablets for oral administration

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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 of hysterectomy, or history of bilateral oophorectomy)
* Men must agree to practice an acceptable method of effective birth control while on study through 11 weeks after receiving the dose of study drug.
* Men must be willing to abstain from sperm donation while on study through 11 weeks after receiving the dose of study drug
* Body Mass Index \> or = 18 and \< or = 38 kg/m\^2 at screening
* Physical examination and 12-lead electrocardiograms (ECGs) are clinically acceptable to the investigator
* Non-hypertensive subjects or subjects with treated, stable hypertension as defined by blood pressure not exceeding 170/100 mm Hg as an average during screening and day -1; for subjects with renal impairment, no change in dosage and medication for \> or = 4 weeks prior to screening, and expected to remain on this dose and medication for the entire duration of the study
* Willing to maintain current general diet and physical activity regimen
* Renal function in 1 of the following 2 categories at the time of screening: Group 1 - Severe Renal Impairment (eGFR 15 to 29 mg/min/1.73 m\^2) and not anticipated to require hemodialysis or renal transplantation, and anticipated to have renal function appropriate to severe renal impairment for the duration of the study OR Group 2 - Normal renal function (eGFR \> or = 90 mg/min/1.73 m\^2)

Exclusion Criteria

* Subjects whose second modification of diet in renal disease (MDRD) eGFR result on day -1 is not within 15% of the first eGFR result performed during the screening period. Healthy volunteers who have normal renal function, but show a difference greater than 15% in eGFR based on MDRD during the screening period, will be included in the trial at the discretion of the investigator and the sponsor after a 24-hour creatinine clearance has been performed that meets eligibility criteria.
* Subjects who are the recipient of a renal transplant and/or are on immunosupressants.
* Subjects with a history of hospitalization for heart disease or angina within 4 months of screening.
* Current or prior malignancy within 5 years of enrollment with the exception of non-melanoma skin cancers, cervical or breast ductal carcinoma in situ, and adenocarcinoma of the prostate Stage I or IIa (defined as T1, T2a or T2b, N0-, M0 with documented serum prostate-specific antigen (PSA) \< 20 ng/mL and Gleason score ≤ 7) per the American Joint Committee on Cancer (AJCC) primary tumor, regional lymph nodes, and distant metastasis system.
* Positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg) or hepatitis C virus antibodies (HepCAb) at screening
* History or evidence of any other clinically significant disorder, condition or disease with the exception of those outlined above that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
* Subject previously has entered this study or has been previously exposed to AMG 986.
* Heart rate ≥ 100 beats per minute after 5 minutes of rest or an untreated symptomatic bradyarrhythmia within 1 month prior to enrollment.
* Known history of drug or alcohol abuse within last 12 months.
* Currently receiving treatment in another investigational device or drug study or less than 30 days or 5 half-lives (whichever is longer) since ending treatment on another investigational device or drug study(s) prior to receiving the dose of investigational product (AMG 986).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes