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NCT Number: NCT03296787

A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intravenous (IV) TAK-954

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.

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Healthy Volunteers Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA CZ, s.r.o, Prague, Czechia

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About this study

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 investigate the impact of hemodialysis on the PK of single IV doses of TAK-954.

The study will enroll approximately up to 40 participants. Participants will be enrolled in one of the 5 treatment groups based on their renal impairment which will be determined based on Cockcroft and Gault (CG) equation as follows:

  • Group A TAK-954 0.2 mg: Healthy Participants
  • Group B TAK-954 0.2 mg: Mild Renal Impairment
  • Group C TAK-954 0.2 mg: Moderate Renal Impairment
  • Group D TAK-954 0.2 mg: Severe Renal Impairment or End-stage Renal Disease (ESRD) Without Hemodialysis
  • Group E TAK-954 0.2 mg: End-stage Renal Disease (ESRD) With Hemodialysis

All participants in groups A to D will receive a single dose of TAK-954 and two single doses in Group E.

Enrollment in Group B (Mild) and Group E (ESRD requiring dialysis) will be based on assessment of safety and available PK data from Group C and Group D respectively.

This multi-center trial will be conducted in Czech Republic and Hungary. The overall time to participate in this study is approximately 8 weeks. Participants in Groups A to D will remain confined to clinic for 3 days. For both treatments, participants in Group E requiring dialysis will remain confined to clinic for 3 days. All participants will make a final visit to the clinic 10-14 days after receiving their last dose for a follow-up assessment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

TAK-954

Drug

TAK-954 intravenous infusion.

Primary outcomes

  1. Groups A, C and D; Cmax: Maximum Observed Plasma Concentration for TAK-954 (Total and Free)

    Time frame: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion

  2. Groups A, C and D; AUC(0-72): Area Under the Plasma Concentration-time Curve From Time 0 to 72 Hours Post-dose for TAK-954 (Free and Total)

    Time frame: Day 1 pre-infusion and at multiple time points (up to 72 hours) post-infusion

  3. Groups A, C and D; AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 (Free and Total)

    Time frame: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion

  4. Groups A, C and D; AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 (Free and Total)

    Time frame: Day 1 pre-infusion and at multiple time points (up to 120 hours) post-infusion

  5. Groups A, C and D; Ae: Amount of TAK-954 Excreted in Urine

    Time frame: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion

  6. Group E; Ae: Amount of TAK-954 Excreted in Urine in Period 1

    Time frame: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion

  7. Group E; Ae: Amount of TAK-954 Excreted in Urine in Period 2

    Time frame: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion

  8. Groups A, C and D; Fe: Fraction of TAK-954 Excreted in Urine

    Time frame: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion

  9. Group E; Fe: Fraction of TAK-954 Excreted in Urine in Period 1

    Time frame: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion

  10. Group E; Fe: Fraction of TAK-954 Excreted in Urine in Period 2

    Time frame: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion

  11. Groups A, C and D; CLR: Renal Clearance for TAK-954

    Time frame: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion

  12. Group E; CLR: Renal Clearance for TAK-954 in Period 1

    Time frame: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion

  13. Group E; CLR: Renal Clearance for TAK-954 in Period 2

    Time frame: Day 1 pre-infusion and at multiple time points (up to 24 hours) post-infusion

  14. Group E; CLD: Clearance of Dialysate for TAK-954 in Period 2

    Time frame: Day 1 pre-infusion and at multiple time points (up to 4 hours) post-infusion

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

A Phase 1, Open-Label, Parallel Group Trial to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics of a Single Intravenous Dose of TAK-954

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 28, 2017
Registry last updated
Aug 25, 2020

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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