TAK-272
DrugTAK-272 tablet
NCT Number: NCT02367872
The purpose of this study is to examine the effects of renal and hepatic impairment on TAK-272 pharmacokinetics with a single oral administration of TAK-272 in participants with renal or hepatic impairment.
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Notify Me20 year–85 year
All sexes
Interventional
Phase 1
Kurume, Fukuoka, Japan
This study is a phase I, open-label, parallel-group, comparative study to evaluate the effects of renal or hepatic impairment on pharmacokinetics of TAK-272 with a single oral administration of TAK-272 in participants with renal or hepatic impairment as compared with participants with normal renal and hepatic function.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
All participants
Participants with normal renal or hepatic function (Cohorts 1R and 1H)
Participants with renal impairment (Cohorts 2R, 3R, 4R, 5R)
Participants with hepatic impairment (Cohorts 2H, 3H)
Exclusion criteria
All participants
Participants with normal renal and hepatic function (Cohorts 1R and 1H)
Participants with renal impairment (Cohorts 2R, 3R, 4R, 5R)
Participants with hepatic impairment (Cohorts 2H, 3H)
TAK-272 tablet
Time frame: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose
Time frame: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose
Time frame: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose
Time frame: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose
AUClast,u is the area under the concentration-time curve of the unbound drug in plasma over the time interval from 0 to time of last quantifiable post-dose of TAK-272.
Time frame: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose
Cmax,u is the peak unbound plasma concentration of a drug after administration, obtained directly from the unbound plasma concentration-time curve.
Time frame: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose
AUC∞,u is the area under the concentration-time curve of the unbound drug in plasma over the time interval from 0 to infinity of TAK-272.
Time frame: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose
Time frame: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose
Time frame: Day 1: Pre-dose and at multiple time points (0.5, 1, 1.5, 2, 3, 4, 5, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120 hours post dose; up to 120 hours) post-dose
CLu/F is the apparent clearance for unbound drug after extravascular administration of TAK-272.
Time frame: Day 1: Pre-dose and at multiple time points (4, 8, 12, 24, 36, 48, 72 hours post dose; up to 72 hours) post-dose
Urinary excretion ratio (percentage [%] of dose) of TAK-272 and its metabolite M-I in urine was calculated for each participant.
Time frame: Baseline
Plasma protein binding rate was the percentage of unbound fraction of TAK-272F in plasma protein.
Time frame: Day 1: Pre-dose, up to 6 hours post-dose
Excretion ratio (% of dose) of TAK-272F in dialysis fluid was calculated for each participant.
Time frame: Baseline up to Day 8 of each Cohort
Time frame: Baseline up to Day 8 of each Cohort
Number of participants with TEAE related to vital signs was reported in this outcome measure. The related event to report was only "Blood Pressure Decreased" throughout this study.
Time frame: Baseline up to Day 8 of each Cohort
Number of participants with TEAE related to body weight was reported in this outcome measure. There were no events to report as TEAE related to body weight throughout this study.
Time frame: Baseline up to Day 8 of each Cohort
Number of participants with TEAE related to ECG was reported in this outcome measure. There were no events to report as TEAE related to ECG throughout this study.
Time frame: Baseline up to Day 8 of each Cohort
Number of participants with TEAE related to laboratory tests was reported in this outcome measure. The related event to report was only "Alanine Aminotransferase Increased" throughout this study.
Takeda
Industry
Phase I Open-label, Parallel-group, Comparative Study to Evaluate the Effects of Renal or Hepatic Impairment on TAK-272 Pharmacokinetics With a Single Oral Administration of TAK-272 in Patients With Renal or Hepatic Impairment
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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