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A Pharmacokinetic (PK) Study of Oral TAK-788 in Participants With Severe Renal Impairment (RI) and Normal Renal Function

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

Summary

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

Description

The drug being tested in this study is called TAK-788. This study is to assess the PK of TAK-788 and its active metabolites (including but not limited to AP32960 and AP32914) in participants with severe RI compared to matched-healthy participants with normal renal function.

The study will enroll approximately 16 participants. Participants will be assigned to 1 of the following 2 treatment groups:

- Severe RI: TAK-788 80 mg

- Normal Renal Function: TAK-788 80 mg

Healthy participants with normal renal function will be recruited to match severe RI 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.

This multi-center trial will be conducted in the United States. The overall time to participate in this study is 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

Renal 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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