NCT03296787

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

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 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.

Conditions

• Renal Impairment
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	TAK-954	TAK-954 intravenous infusion.

Timeline

• Start date: 2017-11-21
• Primary completion: 2019-08-09
• Completion: 2019-08-09
• First posted: 2017-09-28
• Last updated: 2020-08-25
• Results posted: 2020-08-25

Locations

4 sites across 2 countries: Czechia, Hungary

Regulatory

• FDA-regulated drug study