At a glance
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A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-951 in Healthy Subjects Following Intravenous Administration
In Brief
A Phase 1 clinical trial evaluating TAK-951 and TAK-951 Placebo for Healthy Volunteer. Completed, enrolled 32 participants across 1 site.
Detailed Summary
It is hoped that a medicine called TAK-951 will eventually be used to treat nausea and vomiting. Before then, the sponsor needs to understand how the body processes TAK-951 in healthy adults. The main aims of this study are as follows: * To check for side effects from TAK-951 when given at a slow and fast infusion rate. * To learn how much TAK-951 participants can receive without getting side effects from it. Participants will receive a single infusion of either TAK-951 or placebo. In this study, a placebo looks like TAK-951 but does not have any medicine in it. Participants will receive either a low dose or high dose of TAK-951. The infusion will take from 1-3 hours. Participants will stay in the study clinic for about 4 days to receive the study medicine (TAK-951 or placebo) and check for side effects. They will have follow-up visits at the clinic about 2 weeks and 4 weeks after treatment.
Study Details
Timeline
Interventions
TAK-951 intravenous infusion.
TAK-951 placebo-matching intravenous infusion.