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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
ICON
Lenexa, Kansas, United States
ICON
Salt Lake City, Utah, United States
Part 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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.
Time frame: From the first dose of study drug up to Day 29 in Part 1
Part 2: Number of Participants With TEAEs
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.
Time frame: From the first dose of study drug up to Day 33 in Part 2
Part 3: Number of Participants With TEAEs
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.
Time frame: From the first dose of study drug up to Day 27 in Part 3
Part 2: Maximum Observed Plasma Concentration (Cmax) for TAK-951 on Day 1 of Drug Dosing
Time frame: 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
Time frame: 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
Time frame: 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
Tau (τ) indicates the length of the dosing interval.
Time frame: Predose and at multiple time points post-dose up to 24 hours on Day 1 in Part 2
Part 2: AUCτ for TAK-951 at Steady State
τ indicates the length of the dosing interval.
Time frame: Predose and at multiple time points post-dose up to 24 hours on Day 1 in Part 2
Part 2: AUC24 for TAK-951 at Steady State
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Apparent clearance after extravascular administration was to be calculated as Dose/AUCτ after multiple dosing.
Time frame: Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2
Part 2: Apparent Volume of Distribution During the Terminal Disposition Phase After Extravascular Administration (Vz/F) for TAK-951 at Steady State
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.
Time frame: Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2
Part 2: Ctrough: Observed Plasma Concentration at the End of a Dosing Interval for TAK-951 at Steady State
Time frame: 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
Rac\[AUC\] was to be calculated as the ratio of AUCτ at steady state/AUCτ after a single dose.
Time frame: Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2
Part 2: Rac[Cmax]: Accumulation Ratio Based on Cmax for TAK-951 at Steady State
Rac\[Cmax\] was to be calculated as the ratio of Cmax at steady state/Cmax after a single dose.
Time frame: Predose on Day 1 and at multiple time points post-dose up to Day 7 in Part 2
Part 3: Number of Participants With AEs
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.
Time frame: From the re-treatment dose of study drug (any day from Days 8 to 13) up to Day 27 in Part 3
Part 1: Number of Participants Based on Antidrug Antibodies (ADA) Status in Serum
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.
Time frame: Predose on Day 1 and post-dose on Days 14 and 29 in Part 1
Part 2: Number of Participants With ADA
Time frame: Predose on Day 1 and post-dose on Days 14 and 29 in Part 2
Part 3: Number of Participants With ADA
Time frame: Predose on Day 1 and post-dose on Days 14 and 29 in Part 3
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