AMG 986 20150186 Renal Impairment Study

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

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/m2 at screening

- Physical examination and 12-lead 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 m2) 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 m2)

Exclusion Criteria:

- Subjects whose second 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 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).