At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-blind, Placebo-Controlled, Three-part Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-951 in Healthy Subjects
In Brief
A Phase 1 clinical trial evaluating TAK-951 Placebo and TAK-951 for Healthy Volunteers. Completed, enrolled 128 participants across 1 site.
Detailed Summary
This is a study of TAK-951 for people with symptoms of nausea and vomiting. The main aims of this study in healthy adults 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. * To check how much TAK-951 stays in the blood over time to work out the best dose. 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 placebo-matching SC injection
TAK-951 SC injection