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A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral TAK-788 in Participants With Moderate or Severe Hepatic Impairment (HI) and Normal Hepatic Function

2019-08-19 19:46:41 | BioPortfolio

Summary

The purpose of this study is to characterize the single-dose plasma PK of TAK-788 and its active metabolites (AP32960 and AP32914) in participants with moderate and/or severe HI compared to matched-healthy participants with normal hepatic function.

Description

The drug being tested in this study is called TAK-788. The study will assess the PK of single dose TAK-788 and its active metabolites (including but not limited to AP32960 and AP32914) in participants with moderate and/or severe HI compared to matched-healthy participants with normal hepatic function.

The study will enroll approximately 24 participants. Participants will be assigned to 1 of the following 3 treatment groups in a staggered manner based on their degree of hepatic impairment which will be determined based on Child-Pugh Score as follow:

- Moderate HI (Child-Pugh B): TAK-788 40 mg

- Severe HI (Child-Pugh C): TAK-788 40 mg

- Normal Hepatic Function: TAK-788 40 mg

Healthy participants with normal hepatic function will be recruited to match both moderate and severe HI by age (mean plus or minus [+-] 10 years), gender (+-2 participants per gender), and body mass index (BMI, mean +-10 percent [%]).

All participants will be asked to take single dose of TAK-788 on Day 1. The dose level for severe HI may be modified based on the previous results of approximately 3 moderate HI and healthy participants who completed up to Day 10 study procedures.

This multi-center trial will be conducted in the United States. The overall time to participate in this study is approximately 51 days. Participants will be contacted by telephone 30 days after the last dose of study drug for a follow-up assessment.

Study Design

Conditions

Hepatic Impairment

Intervention

TAK-788

Status

Not yet recruiting

Source

Takeda

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-08-19T19:46:41-0400

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