Healthy Volunteers Clinical Trial
Official title:
A Phase 1, Non-Randomized, Open-Label Trial to Evaluate the Effect of Hepatic Impairment on the Single Dose Pharmacokinetics of Intravenous TAK-954
The purpose of this study is to evaluate the effect of varying degrees of hepatic function on the single dose PK of IV TAK-954.
The drug being tested in this study is called TAK-954. This study will evaluate the safety
and tolerability of single intravenous doses of TAK-954 in participants with varying degrees
of hepatic function.
The study will enroll approximately up to 32 participants. Participants will be enrolled in
one of the 4 treatment groups based on their degree of hepatic impairment which will be
determined based on Child-Pugh Score as follow:
- Group 1 TAK-954 0.2 mg: Mild Hepatic Impairment (Child Pugh Class A)
- Group 2 TAK-954 0.2 mg: Moderate Hepatic Impairment (Child Pugh Class B)
- Group 3 TAK-954 0.2 mg: Severe Hepatic Impairment (Child Pugh Class C)
- Group 4 TAK-954 0.2 mg: Healthy Participants
The Child-Pugh classification will assess the severity of 5 hepatic parameters (total serum
bilirubin, serum albumin, prothrombin time, ascites and encephalopathy grade) on a scale of 1
(none) to 3 (moderate). Total hepatic impairment score ranges from 5 (mild) to 15 (severe)
where higher score indicates more severity.
All participants will receive a single dose of TAK-954 0.2 mg on Day 1.
This study may have a full study design, where Group 1 to Group 4 will enroll approximately 8
participants in each group or a reduced study design, where no participants will be enrolled
in Group 1 and approximately 8 participants will be enrolled in Group 2 to Group 4.
This multi-center trial will be conducted in Czech Republic and Slovakia. The overall time to
participate in this study is approximately 7 weeks. Participants will remain confined to the
clinic for 4 days, with 2 further out-patient visits, and will make a final visit to the
clinic 10-14 days after receiving their last dose of TAK-954 for a follow-up assessment.
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