The primary objective of this study is to evaluate the pharmacokinetics (PK), tolerabilty and safety of a single dose of ID-085 in subjects with mild, moderate, and severe renal function impairment compared to healthy subjects
Study Type
INTERVENTIONAL
Purpose
OTHER
Masking
NONE
Enrollment
32
Hard capsules for oral administration formulated at a strength of 200 mg
CRS Clinical Research Services Kiel GmbH
Kiel, Germany
Area under the plasma concentration-time curve (AUC) from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t)
Will be derived by non-compartmental analysis of the plasma concentration-time profiles
Time frame: Up to Day 3 after treatment administration
The plasma AUC from zero to infinity (AUC0-inf), calculated with the apparent λz
Will be derived by non-compartmental analysis of the plasma concentration-time profiles
Time frame: Up to Day 3 after treatment administration
The maximum plasma concentration (Cmax)
Will be derived by non-compartmental analysis of the plasma concentration-time profiles
Time frame: Up to Day 3 after treatment administration
The time to reach Cmax (tmax)
Will be derived by non-compartmental analysis of the plasma concentration-time profiles
Time frame: Up to Day 3 after treatment administration
Apparent total body clearance (CL/F)
Will be derived by non-compartmental analysis of the plasma concentration-time profiles
Time frame: Up to Day 3 after treatment administration
Apparent volume of distribution (Vz/F)
Will be derived by non-compartmental analysis of the plasma concentration-time profiles
Time frame: Up to Day 3 after treatment administration
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