Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610279
Status:
TERMINATED
Last Update Posted:
None
First Post:
2024-09-21
Brief Title:
A Study of TAK-951 in Healthy Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Randomized Double-Blind Sponsor-Open Placebo-Controlled 3-Part Phase 1 Study to Evaluate the Safety Tolerability and Pharmacokinetics of TAK-951 in Healthy Subjects
Status:
TERMINATED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated based on the Sponsors decision attributed to the benefit-risk profile derived from the Part 1 data of this study
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 adults 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None