A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intravenous (IV) TAK-954
Condition: Renal Impairment; Healthy Volunteers
MeSH terms: Renal Insufficiency
Intervention: TAK-954
Intervention description: TAK-954 intravenous infusion.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug therapy

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 the PK of single IV doses of TAK-954.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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).

          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.

          3. 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).

          4. 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 Criteria:

          1. 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.

          2. 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.

          3. 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.