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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
tablets for oral administration
Research Site
Tustin, California, United States
Research Site
Orlando, Florida, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
San Antonio, Texas, United States
AMG 986 Pharmacokinetic (PK) Parameter: Area Under the Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Sample (AUClast)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Predose, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event is defined as any untoward medical occurrence in a clinical trial subject. A serious adverse event is defined as an adverse event that meets at least 1 of the following serious criteria: * fatal * life threatening (places the subject at immediate risk of death) * requires in patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event
Time frame: From first dose of study drug up to Day 30
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