Healthy Volunteers Clinical Trial
Official 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
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.
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.
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