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A Study of TAK-105 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 part 1: day 1 pre-dose and at multiple timepoints (up to day 60) post-dose; part 2: day 1 pre-dose and at multiple timepoints (up to day 6) post-dose; part 2: day 22 pre-dose and at multiple timepoints (up to day 82) post-dose
Summary
This trial is testing a new drug called TAK-105 to see if it can safely treat nausea and vomiting. Healthy adults are participating to help researchers find out if the drug has any side effects and what the safe dosage levels are.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ part 1: day 1 pre-dose and at multiple timepoints (up to day 60) post-dose; part 2: day 1 pre-dose and at multiple timepoints (up to day 6) post-dose; part 2: day 22 pre-dose and at multiple timepoints (up to day 82) post-dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part 1: day 1 pre-dose and at multiple timepoints (up to day 60) post-dose; part 2: day 1 pre-dose and at multiple timepoints (up to day 6) post-dose; part 2: day 22 pre-dose and at multiple timepoints (up to day 82) post-dose
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Participants With At Least One Treatment-emergent Adverse Event (TEAEs)
Secondary study objectives
Number of Participants Based on Antidrug Antibody (ADA) Status
Other study objectives
Part 1, AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-105
Part 2, AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over Dosing Interval for TAK-105
Part 2, Ctrough: Observed Plasma Concentration at the End of a Dosing Interval at Steady State for TAK-105
+11 moreSide effects data
From 2023 Phase 1 trial • 80 Patients • NCT0496425850%
Tachycardia
17%
Dizziness
17%
Supraventricular tachycardia
17%
Oropharyngeal pain
17%
Nausea
17%
Headache
17%
Ventricular tachycardia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 1: TAK-105 Dose 6
Part 1: Placebo
Part 2: TAK-105 Dose 1A
Part 2: Placebo
Part 1: TAK-105 Dose 4
Part 1: TAK-105 Dose 1
Part 1: TAK-105 Dose 5
Part 1: TAK-105 Dose 7
Part 1: TAK-105 Dose 2
Part 1: TAK-105 Dose 3
Part 2: TAK-105 Dose 2A
Trial Design
11Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2: TAK-105 Dose 2AExperimental Treatment1 Intervention
TAK-105-a Dose 2A, injection, subcutaneously, once weekly for 1 week.
Group II: Part 2: TAK-105 Dose 1AExperimental Treatment1 Intervention
TAK-105-a Dose 1A, injection, subcutaneously, once weekly for up to 4 weeks.
Group III: Part 1: TAK-105 Dose 7Experimental Treatment1 Intervention
TAK-105-a Dose 7, injection, subcutaneously, once on Day 1.
Group IV: Part 1: TAK-105 Dose 6Experimental Treatment1 Intervention
TAK-105-a Dose 6, injection, subcutaneously, once on Day 1.
Group V: Part 1: TAK-105 Dose 5Experimental Treatment1 Intervention
TAK-105-a Dose 5, injection, subcutaneously, once on Day 1.
Group VI: Part 1: TAK-105 Dose 4Experimental Treatment1 Intervention
TAK-105-a Dose 4, injection, subcutaneously, once on Day 1.
Group VII: Part 1: TAK-105 Dose 3Experimental Treatment1 Intervention
TAK-105-a Dose 3, injection, subcutaneously, once on Day 1.
Group VIII: Part 1: TAK-105 Dose 2Experimental Treatment1 Intervention
TAK-105-a Dose 2, injection, subcutaneously, once on Day 1.
Group IX: Part 1: TAK-105 Dose 1Experimental Treatment1 Intervention
TAK-105-a Dose 1, injection, subcutaneously, once on Day 1.
Group X: Part 1: PlaceboPlacebo Group1 Intervention
TAK-105-a matching-placebo, injection, subcutaneously, once on Day 1.
Group XI: Part 2: PlaceboPlacebo Group1 Intervention
TAK-105-a matching-placebo, injection, subcutaneously, once weekly for 4 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAK-105-a
2021
Completed Phase 1
~80
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
4,148,938 Total Patients Enrolled
Study DirectorStudy DirectorTakeda
1,281 Previous Clinical Trials
500,422 Total Patients Enrolled