A Study of TAK-951 in Healthy Adults

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteers

In brief

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).

Key facts

Study ID

NCT06610279

Run by

Takeda

People needed

48

Starts

2022-01-07

Expected to finish

2023-09-21

Last updated by the study team

2024-11-22

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• To be eligible for participation in this study, the participant must:
• Understand the study procedures and agree to participate by providing written informed consent.
• Be willing and able to comply with all study procedures and restrictions.
• Be a healthy man or woman aged 18 to 55 years, inclusive, at the screening visit.
• Be a continuous nonsmoker who has not used nicotine and tobacco-containing products for at least 3 months prior to dosing and throughout the study.
• Have a body mass index (BMI) greater than equal to (≥)18 and less than equal to (≤)32 kilograms per meter square (kg/m\^2) at the screening visit.
• Be judged to be in good health (e.g., no evidence of psychiatric, hepatic, renal, pulmonary, or cardiovascular (CV) disease) by the investigator, based on clinical evaluations including laboratory safety tests, medical history, physical examination, ECG, and vital sign measurements performed at the screening visit and before administration of the initial dose of study drug or invasive procedure.
• Meet the following birth control requirements:
• Is a male participant who is sterile or agrees to use an appropriate method of contraception, including a condom with or without spermicidal cream or jelly, from the first dose of study drug until 30 days after the last dose of study drug. No restrictions are required for a vasectomized male participant provided the participant is at least 1 year after bilateral vasectomy procedure before the first dose of study drug. A male participant whose vasectomy procedure was performed less than 1 year before the first dose of study drug must follow the same restrictions as a non-vasectomized man. Appropriate documentation of surgical procedure should be provided.
• Is a male participant who agrees not to donate sperm from the first dose of study drug until 30 days after the last dose of study drug.
• Women of childbearing potential are eligible for the study provided they have a negative pregnancy test, are not lactating or breastfeeding, and are willing and agreeable to use highly effective contraception during the study and up to 30 days after the last dose of study drug.
• Is a female participant of nonchildbearing potential, defined by at least 1 of the following criteria:
• Postmenopausal (defined as 12 months of spontaneous amenorrhea in females aged greater than (>)45 years or 6 months of spontaneous amenorrhea in females aged >45 years with serum follicle-stimulating hormone (FSH) levels >40 milli-international units per milliliter [mIU/mL]). Appropriate documentation of FSH levels is required.
• Surgically sterile by hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy with appropriate documentation of surgical procedure.
• Had a bilateral tubal ligation with appropriate documentation of surgical procedure.
• Has a congenital condition resulting in no uterus. Exclusion Criteria
• Any participant who meets any of the following criteria will not qualify for entry into the study:
• The participant has participated in another investigational study within 4 weeks (or based on local regulations) or within 5 half-lives, whichever is longest, of the investigational product before the screening visit. The 4-week or 5 half-lives window will be derived from the date of the last dose and/or AE related to the study procedure in the previous study to the screening visit of the current study.
• The participant is an employee of the sponsor or study site or immediate family member (e.g., spouse, parent, child, sibling) of the sponsor or study site.
• The participant has a history of significant multiple and/or severe allergies (e.g., food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance to prescription or nonprescription drugs or food, as determined by the investigator.
• The participant has a known hypersensitivity or contraindication to any component of TAK-951.
• The participant has a positive pregnancy test or is lactating or breastfeeding.
• The participant has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency antibody/antigen, at the screening visit.
• The participant had major surgery or donated or lost 1 unit of blood (approximately 500 milliliters [mL]) within 4 weeks before the screening visit.
• The participant is unable to refrain from or anticipates using any medications including herbal medicines beginning approximately 7 days before administration of the first dose of study drug, throughout the study until 2 days after discharge.

Where it is running

• ICON — Lenexa, Kansas, United States
• ICON — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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