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Clinical Trial Details

Trial ID: L1711
Source ID: NCT02218099
Associated Drug: Asp8232
Title: A Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of ASP8232 in Subjects With Renal Impairment and in Type 2 Diabetes Mellitus Subjects With Chronic Kidney Disease
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Healthy Subjects|Pharmacokinetics of ASP8232|Pharmacodynamics of ASP8232|Chronic Kidney Disease (CKD)|Type 2 Diabetes Mellitus (T2DM)
Interventions: DRUG: ASP8232|DRUG: Placebo
Outcome Measures: Primary: Part 1: PK of ASP8232 in plasma measured by Area Under the concentration-time Curve (AUC) from zero to infinity with extrapolation of the terminal phase (AUCinf), Day 1 to Day 56|Part 1: PK of ASP8232 in plasma measured by AUC from zero up to last time point of observation (AUClast), Day 1 to Day 56|Part 1: PK of ASP8232 in plasma measured by AUC from zero up to last time point of observation, unbound fraction (AUClast,u), Day 1 to Day 56|Part 1: PK of ASP8232 in plasma measured by AUC from 0 to infinity with extrapolation of the terminal phase, unbound fraction (AUCinf,u), Day 1 to Day 56|Part 1: PK of ASP8232 in plasma measured by maximum concentration (Cmax), Day 1 to Day 56|Part 1: PK of ASP8232 in plasma measured by maximum concentration, unbound fraction (Cmax,u), Day 1 to Day 56|Part 2: Safety and tolerability of ASP8232 measured by nature, frequency and severity of AEs, vital signs, safety laboratory tests, routine ECG, Screening to End of Study Visit (ESV) | Secondary: Part 1: PK profile of ASP8232 in plasma, apparent total plasma clearance of drug after oral administration (CL/F), renal clearance based on unbound plasma concentrations (CLu/F), fraction unbound (fu), lag-time (time delay between drug administration and first observed concentration above LOQ in plasma) (tlag), time to reach Cmax (tmax), terminal elimination half-life (t1/2), apparent volume of distribution during terminal phase after oral administration (Vz/F), apparent volume of distribution during terminal phase after oral administration, unbound fraction (Vz,u/F), Day 1 to Day 56|Part 1: PK profile of ASP8232 in urine, renal clearance (CLR), CLR unbound fraction (CLR,u), amount of drug excreted in urine from time point 0 to time point 24 h (Ae0-24h), percent of drug excreted in urine from time point 0 to time point 24 h (Ae0-24h%), cumulative amount of drug excreted in urine from time of dosing up to the collection time of the last measurable concentration (Aelast), percent of drug dose excreted in urine (Aelast) from time of dosing up to the collection time of the last measurable concentration (Aelast%), cumulative amount of drug excreted in urine from time of dosing extrapolated to time infinity (Aeinf), percent of drug dose excreted in urine (Aeinf) from time of dosing extrapolated to time infinity (Aeinf%), Day -1 to Day 8|Part 1: PD of Vascular adhesion protein-1 (VAP-1) activity in plasma, maximum activity (Rmax), maximum activity in percent (Rmax%), time to attain maximal Response (tmax, R), average response over the first 24 h after dosing (Ravg, 0-24h), Day -1 to Day 56|Part 1: PD of Total antioxidant status (TAS) in serum, Rmax, Rmax%, tmax, R, Ravg, 0-24h, Day -1 to Day 56|Part 1: Safety and tolerability of ASP8232, nature, frequency and severity of Adverse Events (AEs), vital signs, safety laboratory tests, routine Electrocardiogram (ECG), Screening to Day 56|Part 2: PK profile of ASP8232 in plasma, free drug fraction (fu), area under the concentration-time curve from the time of dosing to the start of the next dosing interval (AUCtau), area under the concentration-time curve during a dosing interval at steady state, unbound fraction (AUCtau,u), tmax, Cmax, Cmax,u, CL/F, CLu/F, Peak Trough Ratio (PTR), concentration immediately prior to dosing at multiple dosing (Ctrough), Ctrough, unbound (Ctrough, u), Day 1 to Day 29|Part 2: PK profile of ASP8232 in urine, amount of unchanged drug excreted in urine over a dosing interval in steady state (Aetau), amount of unchanged drug excreted in urine over a dosing interval in steady state in % (Aetau%), CLR, CLR,u, Day 1 to Day 8 and Day 28 to Day 29|Part 2: PD of VAP-1 activity in plasma, Rmax and Rmax%, Day -2 to Day 21 and Day 28 to ESV|Part 2: PD of TAS in serum, Rmax, Rmax%, tmax, R, Ravg, 0-24h, Day -2 to Day 21 and Day 28 to ESV|Part 2: 24-hour urinary albumin excretion rate (UAER), Day -1, Day 7 and Day 28
Sponsor/Collaborators: Sponsor: Astellas Pharma Europe B.V.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 55
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
Start Date: 2013-09-16
Completion Date: 2014-09-09
Results First Posted:
Last Update Posted: 2024-10-31
Locations: Site: 35901, Sofia, 1612, Bulgaria|Site: 37301, Chisinau, Moldova, Republic of|Site: 40001, Bucharest, 10731, Romania
URL: https://clinicaltrials.gov/show/NCT02218099