NCT06768658

A Study of TAK-951 in Participants With Cyclic Vomiting Syndrome (CVS)

A Randomized, Double-Blind, Placebo-Controlled Repeated Crossover Study to Evaluate the Safety and Tolerability of Intermittent Single Doses of TAK-951 in the Abortive Treatment of Subjects With Cyclic Vomiting Syndrome

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This is a study of TAK-951 in participants with cyclic vomiting syndrome (CVS). The main aims of this study are as follows: * To check for side effects from treatment with TAK-951. * 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. * The dose of TAK-951 will be checked to see how much stays in their blood over time. * To see if it is possible to give treatment at home. Participants will be given TAK-951 injected just under the skin (subcutaneous or SC).

Conditions

• Nausea and Vomitting

Interventions

Type	Name	Description
DRUG	TAK-951	TAK-951 subcutaneous injection.
DRUG	TAK-951 Placebo	TAK-951 placebo-matching subcutaneous injection.

Timeline

• Start date: 2022-03-02
• Primary completion: 2023-01-09
• Completion: 2023-01-09
• First posted: 2025-01-10
• Last updated: 2025-07-02
• Results posted: 2025-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study