Status:
COMPLETED
A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intravenous (IV) TAK-954
Lead Sponsor:
Takeda
Conditions:
Renal Impairment
Healthy Volunteers
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the effect of varying degrees of renal function on the PK of TAK-954 following single-dose IV administration and to investigate the impact of hemodialysis on t...
Detailed Description
The drug being tested in this study is called TAK-954. This study will evaluate the effect of varying degrees of renal function on the PK of TAK-954 following single-dose IV administration and to inve...
Eligibility Criteria
Inclusion
- All participants: Male and female participants (non-childbearing potential) who are aged 18 to 75 years, inclusive, with a body mass index (BMI) between 18 to 35 kilogram per square meter (kg/m\^2).
- Group A: As much as possible, the healthy participants with normal renal function (creatinine clearance \[CLcr\] greater than or equal to \[\>=\] 90 milliliter per minute \[mL/min\]) should be comparable to participants with renal impairment with respect to median age and weight (approximately 50 percent \[%\] of healthy participants on each side of the median age and weight of currently enrolled renally-impaired participants grouped together), sex, and race. This will be decided by the investigators in discussion with Takeda.
- Groups B to E: Participants who have stable RI, defined as no clinically significant change in disease status, as documented by the participant's most recent CLcr assessment; serum creatinine must not vary more than approximately 30% from Screening to Day -1 to confirm stable disease. Participants should also be in good health commensurate with their renal status.
- Group B: Participants with mild RI (CLcr 60 to less than \[\<\] 90 mL/min).
- Group C: Participants with moderate RI (CLcr 30 to \<60 mL/min).
- Group D: Participants with severe RI or ESRD but not requiring dialysis (CLcr \<30 mL/min).
- Group E: Participants with ESRD requiring dialysis (\<15 mL/min requiring hemodialysis at least 3 times/week, and having been on the same dialysis treatment regimen for at least 1 month before trial entry).
- Participants should be on a stable drug regimen defined as not starting a new drug or changing dosage within 7 days or 5 half-lives (whichever is longer) before dosing with TAK-954.
Exclusion
- All participants:
- Are renal allograft recipients within 1 year of screening.
- Have a history of gastrointestinal (GI) motility disorder or intestinal obstruction.
- Have urinary incontinence without catheterization.
- Group A: Participants who, in the discretion of the investigator, have a history of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases will be excluded from the trial.
- Groups B to E:
- Receive dialysis other than intermittent dialysis (except Group E).
- Have renal disease secondary to hepatic disease (hepatorenal syndrome).
- At the discretion of the investigators, have any significant hepatic, cardiac, or pulmonary disease or participants who are clinically nephrotic.
Key Trial Info
Start Date :
November 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 9 2019
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03296787
Start Date
November 21 2017
End Date
August 9 2019
Last Update
August 25 2020
Active Locations (4)
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1
PRA CZ, s.r.o
Prague, Prague, Czechia, 170 00
2
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Czechia, 500 05
3
PRA Magyarorszag Kft.
Budapest, Hungary, 1077
4
Szent Imre Egyetemi Oktatokorhaz Belgyogyazati Szakmak Matrix Intezet
Budapest, Hungary, 1115