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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Continuous nonsmoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to dosing and throughout the study.
Body mass index (BMI) greater than or equal to (>=) 18.0 and less than or equal to (<=) 30.0 kilogram per square meter (kg/m^2) at the screening visit.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part 1, day 1: pre-dose and at multiple time points (up to 24 hours) post-dose; part 2, days 1 and 5: pre-dose and at multiple time points (up to 24 hours) post-dose
Awards & highlights
Study Summary
This trial is testing TAK-510, a new potential treatment for nausea and vomiting, in healthy adults. The study will assess side effects and find the maximum tolerated dose of TAK-510. The trial will be conducted in three parts, with participants receiving either TAK-510 or placebo in different doses. Part 1 will test a single dose, while Part 2 will test daily doses for five days. Part 3 will test two doses, one given seven days apart. All participants will be monitored for side effects after each dose.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ part 1, day 1: pre-dose and at multiple time points (up to 24 hours) post-dose; part 2, days 1 and 5: pre-dose and at multiple time points (up to 24 hours) post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part 1, day 1: pre-dose and at multiple time points (up to 24 hours) post-dose; part 2, days 1 and 5: pre-dose and at multiple time points (up to 24 hours) post-dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Parts 1 and 2: Number of Participants Reporting One or More Treatment-emergent Adverse Event (TEAE)
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters at Least Once Post Dose
Parts 1 and 2: Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Dose
+1 moreSecondary outcome measures
Part 3, Number of Participants Reporting One or More TEAE Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens
Part 3, Number of Participants Who Met the Markedly Abnormal Criteria for ECG Parameters at Least Once Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens
Part 3, Number of Participants Who Met the Markedly Abnormal Criteria for Laboratory Value at Least Once Post Single Subcutaneous Rechallenge Doses After a Washout From Multiple Subcutaneous Dose Regimens
+5 moreOther outcome measures
Part 1, AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-510
Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-510
Part 1, CL/F: Apparent Clearance After Extravascular Administration for TAK-510
+19 moreSide effects data
From 2022 Phase 1 trial • 124 Patients • NCT0473192257%
Tachycardia
43%
Myalgia
29%
Orthostatic hypotension
29%
Dizziness
14%
Nervousness
14%
Headache
14%
Hyperhidrosis
14%
Abdominal discomfort
14%
Photopsia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1, SRD Cohort 4: TAK-510 Dose 4
Part 1, SRD Cohort 11: TAK-510 Dose 11
Part 1, SRD Cohort 2: TAK-510 Dose 2
Part 2, MRD Cohort: Dose 1A
Part 2, MRD Cohort 15: Dose 4A
Part 1, SRD Cohort 8: TAK-510 Dose 8
Part 1, SRD Cohort 9: TAK-510 Dose 9
Part 1, SRD Cohorts 1 to 11: Pooled Placebo
Part 1, SRD Cohort 1: TAK-510 Dose 1
Part 1, SRD Cohort 3: TAK-510 Dose 3
Part 1, SRD Cohort 6: TAK-510 Dose 6
Part 1, SRD Cohort 7: TAK-510 Dose 7
Part 1, SRD Cohort 10: TAK-510 Dose 10
Part 1, SRD Cohort 5: TAK-510 Dose 5
Part 2, MRD 12 to 15 Cohorts: Pooled Placebo
Part 2, MRD Cohort 13: Dose 2A
Part 2, MRD Cohort 14: Dose 3A
Trial Design
3Treatment groups
Experimental Treatment
Group I: TAK-510: Part 3Experimental Treatment2 Interventions
TAK-510 TBD or placebo-matching solution, subcutaneously, once daily from Days 1 to 7. Dose of dose titration and redosing Cohorts (Cohorts 18-20) of Part 3 will be based on emerging safety, tolerability, and available PK data from Part 1 (SRD) and Part 2 (MRD) as determined in the dose escalation meeting. Single redosing will be performed on Day 14 after 7 days of washout period following the 7 days treatment period.
Group II: TAK-510: Part 2Experimental Treatment2 Interventions
TAK-510 to be decided (TBD) or placebo-matching solution, subcutaneously, once daily from Day 1 through Day 5. Dose of MRD Cohorts (Cohorts 13-17 and 26-28) of Part 2 will be determined based on emerging safety, tolerability, and available PK data from Part 1 (SRD) and any available PK data from Part 2 as determined in the dose escalation meeting.
Group III: TAK-510: Part 1Experimental Treatment2 Interventions
TAK-510 at starting dose of 5 microgram (mcg) or placebo-matching solution, subcutaneously, once on Day 1. Staggered dosing will be done in the first cohort of Part A (Cohort 1). Staggered dosing in subsequent Cohorts (Cohorts 2-12 and 21-25) will be used based on emerging safety, tolerability, and PK data from Cohort 1 as determined in the dose escalation meeting.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-510
2021
Completed Phase 1
~130
TAK-510 Placebo
2021
Completed Phase 1
~130
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
TakedaLead Sponsor
1,202 Previous Clinical Trials
4,178,138 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,207 Previous Clinical Trials
489,556 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Nevada
Texas
How old are they?
18 - 65
What site did they apply to?
PPD Development, LP
What portion of applicants met pre-screening criteria?
Met criteria
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