← Back to Search

A Study of TAK-951 in Healthy Adults

Phase 1
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the re-treatment dose of study drug (any day from days 8 to 13) up to day 27 in part 3

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).

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the re-treatment dose of study drug (any day from days 8 to 13) up to day 27 in part 3
This trial's timeline: 3 weeks for screening, Varies for treatment, and from the re-treatment dose of study drug (any day from days 8 to 13) up to day 27 in part 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Part 2: Number of Participants With TEAEs
Part 3: Number of Participants With TEAEs
Secondary study objectives
Part 1: Number of Participants Based on Antidrug Antibodies (ADA) Status in Serum
Part 2: AUCτ for TAK-951 at Steady State
Part 2: AUCτ: Area Under the Plasma Concentration-time Curve During a Dosing Interval for TAK-951 on Day 1
+5 more
Other study objectives
Part 1: AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours for TAK-951
Part 1: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Last Quantifiable Concentration for TAK-951
Part 1: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-951
+5 more

Side effects data

From 2022 Phase 2 trial • 89 Patients • NCT04557189
39%
Procedural hypotension
15%
Tachypnoea
15%
Flatulence
10%
Bradycardia
10%
Sinus tachycardia
7%
Hypotension
2%
Chills
2%
Hypertension
2%
Pruritus
2%
Anxiety
2%
Blood pressure increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron 4 mg IV
TAK-951 4 mg SC
TAK-951 Redacted mg SC

Trial Design

9Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 3: TAK-951 Multiple Dose TitrationExperimental Treatment1 Intervention
Participants will receive multiple rising SC doses of TAK-951 once daily (QD), BID, or TID from Days 1 to 5 followed by a washout period of 2 to 7 days and a single redose on any day from Days 8 to 13 in Part 3.
Group II: Part 2: TAK-951 Multiple Rising DosesExperimental Treatment1 Intervention
Participants will receive multiple rising SC doses of TAK-951 twice daily (BID) or 3 times a day (TID) in Part 2.
Group III: Part 1, Cohort 6: TAK-951 Dose 6Experimental Treatment1 Intervention
Participants will receive a single SC dose of TAK-951 Dose 6 on Day 1.
Group IV: Part 1, Cohort 5: TAK-951 Dose 5Experimental Treatment1 Intervention
Participants will receive a single SC dose of TAK-951 Dose 5 on Day 1.
Group V: Part 1, Cohort 4: TAK-951 Dose 4Experimental Treatment1 Intervention
Participants will receive a single SC dose of TAK-951 Dose 4 on Day 1.
Group VI: Part 1, Cohort 3: TAK-951 Dose 3Experimental Treatment1 Intervention
Participants will receive a single SC dose of TAK-951 Dose 3 on Day 1.
Group VII: Part 1, Cohort 2: TAK-951 Dose 2Experimental Treatment1 Intervention
Participants will receive a single SC dose of TAK-951 Dose 2 on Day 1.
Group VIII: Part 1, Cohort 1: TAK-951 Dose 1Experimental Treatment1 Intervention
Participants will receive a single SC dose of TAK-951 Dose 1 on Day 1.
Group IX: Part 1: Pooled PlaceboPlacebo Group1 Intervention
Participants will receive a single SC dose of TAK-951 matching placebo on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-951
2019
Completed Phase 2
~250

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

TakedaLead Sponsor
1,238 Previous Clinical Trials
4,148,970 Total Patients Enrolled
~12 spots leftby Dec 2025