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A Study of TAK-951 in Healthy Adults

NCT06610279 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2024-11-22

Study results available
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Summary

Feeling sick in the stomach (nausea) or throwing up (vomiting) are among the most common symptoms during treatment with medicines. It is hoped that a medicine called TAK-951 may help people to not feel sick in the stomach or throw up. The main aim of this study is to learn about side effects of TAK-951 when given as a single or multiple doses to healthy adults. Side effects are medical problems thought to be caused by the study treatment. Another aim is to learn how a healthy adult's body processes TAK-951 (this is called pharmacokinetics or PK). In this study, participants will receive either TAK-951 or placebo. The placebo looks like TAK-951 but does not have any medicine in it. Both TAK-951 and placebo will be given as an injection directly under the skin. This is called subcutaneous or subcutaneous (SC).

The study will be conducted in 3 parts:

* In Part 1, participants will be given one SC injection of either TAK-951 or placebo.
* In Part 2, participants will receive up to three daily SC injections of either TAK-951 or placebo of the same dose
* In Part 3, participants will receive one SC injection of either TAK-951 or placebo and another SC injection up to 1 week later.

Participants will be checked for their health either 28 days after the last injection (Parts 1 and 2) or 14 days after the last injection (Part 3).

Conditions

  • Healthy Volunteers

Interventions

DRUG

TAK-951

TAK-951 SC injection

DRUG

Placebo

TAK-951 matching placebo SC injection

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-07
Primary Completion
2023-09-21
Completion
2023-09-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06610279 on ClinicalTrials.gov