A Study of TAK-951 in Healthy Adults
- Conditions
- Healthy Volunteers
- Interventions
- Drug: PlaceboDrug: TAK-951
- Registration Number
- NCT06610279
- Lead Sponsor
- Takeda
- 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 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1: Pooled Placebo Placebo Participants will receive a single SC dose of TAK-951 matching placebo on Day 1. Part 1, Cohort 1: TAK-951 Dose 1 TAK-951 Participants will receive a single SC dose of TAK-951 Dose 1 on Day 1. Part 1, Cohort 2: TAK-951 Dose 2 TAK-951 Participants will receive a single SC dose of TAK-951 Dose 2 on Day 1. Part 1, Cohort 3: TAK-951 Dose 3 TAK-951 Participants will receive a single SC dose of TAK-951 Dose 3 on Day 1. Part 1, Cohort 4: TAK-951 Dose 4 TAK-951 Participants will receive a single SC dose of TAK-951 Dose 4 on Day 1. Part 1, Cohort 5: TAK-951 Dose 5 TAK-951 Participants will receive a single SC dose of TAK-951 Dose 5 on Day 1. Part 1, Cohort 6: TAK-951 Dose 6 TAK-951 Participants will receive a single SC dose of TAK-951 Dose 6 on Day 1. Part 2: TAK-951 Multiple Rising Doses TAK-951 Participants will receive multiple rising SC doses of TAK-951 twice daily (BID) or 3 times a day (TID) in Part 2. Part 3: TAK-951 Multiple Dose Titration TAK-951 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.
- Primary Outcome Measures
Name Time Method Part 3: Number of Participants With TEAEs From the first dose of study drug up to Day 27 in Part 3 An 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, 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.
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) 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.
Part 2: Number of Participants With TEAEs From the first dose of study drug up to Day 33 in Part 2 An 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, 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.
- Secondary Outcome Measures
Name Time Method Part 2: Maximum Observed Plasma Concentration (Cmax) for TAK-951 on Day 1 of Drug Dosing Predose and at multiple time points post-dose up to 24 hours on Day 1 in Part 2 Part 2: Time of First Occurrence of Cmax (Tmax) for TAK-951 on Day 1 of Drug Dosing Predose and at multiple time points post-dose up to 24 hours on Day 1 in Part 2 Part 2: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC24) for TAK-951 on Day 1 of Drug Dosing Predose and at multiple time points post-dose up to 24 hours on Day 1 in Part 2 Part 2: AUCτ: Area Under the Plasma Concentration-time Curve During a Dosing Interval for TAK-951 on Day 1 Predose and at multiple time points post-dose up to 24 hours on Day 1 in Part 2 Tau (τ) indicates the length of the dosing interval.
Part 2: AUCτ for TAK-951 at Steady State Predose and at multiple time points post-dose up to 24 hours on Day 1 in Part 2 τ indicates the length of the dosing interval.
Part 2: AUC24 for TAK-951 at Steady State Predose on Day 1 and at multiple time points post-dose up to 24 hours on Day 1 in Part 2 Part 2: Cmax,ss: Maximum Observed Concentration at Steady State for TAK-951 Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2 Part 2: Tmax for TAK-951 at Steady State Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2 Part 2: Terminal Disposition Phase Half-life (t1/2z) for TAK-951 at Steady State Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2 Part 2: Apparent Clearance After Extravascular Administration (CL/F) for TAK-951 at Steady State Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2 Apparent clearance after extravascular administration was to be calculated as Dose/AUCτ after multiple dosing.
Part 2: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration (Vz/F) for TAK-951 at Steady State Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2 Apparent volume of distribution during the terminal disposition phase after extravascular administration was to be calculated as (CL/F)/λz at steady state, with λz as the terminal elimination rate constant.
Part 2: Ctrough: Observed Plasma Concentration at the End of a Dosing Interval for TAK-951 at Steady State Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2 Part 2: Rac[AUC]: Accumulation Ratio Based on AUCτ for TAK-951 at Steady State Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2 Rac\[AUC\] was to be calculated as the ratio of AUCτ at steady state/AUCτ after a single dose.
Part 2: Rac[Cmax]: Accumulation Ratio Based on Cmax for TAK-951 at Steady State Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2 Rac\[Cmax\] was to be calculated as the ratio of Cmax at steady state/Cmax after a single dose.
Part 3: Number of Participants With AEs From the re-treatment dose of study drug (any day from Days 8 to 13) up to Day 27 in Part 3 An 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, 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.
Part 1: Number of Participants Based on Antidrug Antibodies (ADA) Status in Serum 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-positive only, high ADA titer was defined as participant who had at least 1 postbaseline ADA titer \>16; low ADA titer was defined as participant whose postbaseline ADA titers were all ≤16 and data is presented accordingly for each of these categories.
Part 2: Number of Participants With ADA Predose on Day 1 and post-dose on Days 14 and 29 in Part 2 Part 3: Number of Participants With ADA Predose on Day 1 and post-dose on Days 14 and 29 in Part 3
Trial Locations
- Locations (1)
ICON
🇺🇸Salt Lake City, Utah, United States