Adults 18 to 55, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)Primary· From the first dose of study drug up to Day 29 in Part 1
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug. An AE can be any unfavorable and unintended sign (including physical examinations, vital signs, electrocardiogram (ECG), laboratory assessment findings), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE was defined as an AE that started or worsened after first study drug administration and within 30 days of last dose of study drug.
Group
Value
95% CI
Part 1: Pooled Placebo
6
Part 1, Cohort 1: TAK-951 Dose 1
4
Part 1, Cohort 2: TAK-951 Dose 2
5
Part 1, Cohort 3: TAK-951 Dose 3
6
Part 1, Cohort 4: TAK-951 Dose 4
5
Part 1, Cohort 5: TAK-951 Dose 5
4
Part 1, Cohort 6: TAK-951 Dose 6
6
Part 1: Number of Participants Based on Antidrug Antibodies (ADA) Status in SerumSecondary· Predose on Day 1 and post-dose on Days 14 and 29 in Part 1
A 3-tiered ADA testing strategy was used in this study. A sample was initially screened for ADA by the ADA screening assay. Any positive sample in the screening assay was considered a potential positive, which was confirmed for true positivity by the confirmatory assay. If a sample was confirmed as an ADA true positive, ADA titer was assessed. ADA-positive was defined as participants who have confirmed positive ADA status in at least 1 postbaseline assessments. ADA-negative was defined as participants who did not have a confirmed positive ADA status in any postbaseline assessment. For ADA-posi
Day 1: Negative
Group
Value
95% CI
Part 1: Pooled Placebo
12
Part 1, Cohort 1: TAK-951 Dose 1
6
Part 1, Cohort 2: TAK-951 Dose 2
6
Part 1, Cohort 3: TAK-951 Dose 3
6
Part 1, Cohort 4: TAK-951 Dose 4
5
Part 1, Cohort 5: TAK-951 Dose 5
6
Part 1, Cohort 6: TAK-951 Dose 6
6
Day 1: Positive: Low Titer
Group
Value
95% CI
Part 1: Pooled Placebo
0
Part 1, Cohort 1: TAK-951 Dose 1
0
Part 1, Cohort 2: TAK-951 Dose 2
0
Part 1, Cohort 3: TAK-951 Dose 3
0
Part 1, Cohort 4: TAK-951 Dose 4
1
Part 1, Cohort 5: TAK-951 Dose 5
0
Part 1, Cohort 6: TAK-951 Dose 6
0
Day 1: Positive: High Titer
Group
Value
95% CI
Part 1: Pooled Placebo
0
Part 1, Cohort 1: TAK-951 Dose 1
0
Part 1, Cohort 2: TAK-951 Dose 2
0
Part 1, Cohort 3: TAK-951 Dose 3
0
Part 1, Cohort 4: TAK-951 Dose 4
0
Part 1, Cohort 5: TAK-951 Dose 5
0
Part 1, Cohort 6: TAK-951 Dose 6
0
Day 14: Negative
Group
Value
95% CI
Part 1: Pooled Placebo
12
Part 1, Cohort 1: TAK-951 Dose 1
6
Part 1, Cohort 2: TAK-951 Dose 2
6
Part 1, Cohort 3: TAK-951 Dose 3
6
Part 1, Cohort 4: TAK-951 Dose 4
5
Part 1, Cohort 5: TAK-951 Dose 5
6
Part 1, Cohort 6: TAK-951 Dose 6
6
Day 14: Positive: Low Titer
Group
Value
95% CI
Part 1: Pooled Placebo
0
Part 1, Cohort 1: TAK-951 Dose 1
0
Part 1, Cohort 2: TAK-951 Dose 2
0
Part 1, Cohort 3: TAK-951 Dose 3
0
Part 1, Cohort 4: TAK-951 Dose 4
1
Part 1, Cohort 5: TAK-951 Dose 5
0
Part 1, Cohort 6: TAK-951 Dose 6
0
Day 14: Positive: High Titer
Group
Value
95% CI
Part 1: Pooled Placebo
0
Part 1, Cohort 1: TAK-951 Dose 1
0
Part 1, Cohort 2: TAK-951 Dose 2
0
Part 1, Cohort 3: TAK-951 Dose 3
0
Part 1, Cohort 4: TAK-951 Dose 4
0
Part 1, Cohort 5: TAK-951 Dose 5
0
Part 1, Cohort 6: TAK-951 Dose 6
0
Day 29: Negative
Group
Value
95% CI
Part 1: Pooled Placebo
12
Part 1, Cohort 1: TAK-951 Dose 1
6
Part 1, Cohort 2: TAK-951 Dose 2
6
Part 1, Cohort 3: TAK-951 Dose 3
6
Part 1, Cohort 4: TAK-951 Dose 4
5
Part 1, Cohort 5: TAK-951 Dose 5
6
Part 1, Cohort 6: TAK-951 Dose 6
6
Day 29: Positive: Low Titer
Group
Value
95% CI
Part 1: Pooled Placebo
0
Part 1, Cohort 1: TAK-951 Dose 1
0
Part 1, Cohort 2: TAK-951 Dose 2
0
Part 1, Cohort 3: TAK-951 Dose 3
0
Part 1, Cohort 4: TAK-951 Dose 4
1
Part 1, Cohort 5: TAK-951 Dose 5
0
Part 1, Cohort 6: TAK-951 Dose 6
0
Adverse events — posted to ClinicalTrials.gov
Time frame: From the first dose of study drug up to Day 29 in Part 1.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
NCT06768658 — A Study of TAK-951 in Participants With Cyclic Vomiting Syndrome (CVS)
· Phase 1
· terminated
NCT04557189 — A Study of TAK-951 to Stop Adults Getting Nausea and Vomiting After Planned Surgery
· Phase 2
· completed
NCT04486950 — A Study of TAK-951 in Healthy Adults
· Phase 1
· completed
NCT05567393 — A Study of TAK-951 in Healthy Adults
· Phase 1
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 22 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06610279.