A Study of TAK-951 in Healthy Adults

NCT06610279 | Terminated Phase 1 Results FDA Drug

• 1 other identifier: TAK-951-1008
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

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).

Conditions

Healthy Volunteers

Keywords

TAK-951

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From the first dose of study drug up to Day 27 in Part 3

Secondary Outcomes (18)

• 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

• 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

Other Outcomes (8)

• Part 1: Cmax: Maximum Observed Plasma Concentration of TAK-951

  Predose on Day 1 and at multiple time points post-dose up to Day 3 in Part 1

• Part 1: AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours for TAK-951

  Predose and at multiple time points post-dose up to 24 hours on Day 1 in Part 1

• Part 1: AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-951

  Predose on Day 1 and at multiple time points post-dose up to Day 3 in Part 1

Study Arms (9)

Part 1: Pooled Placebo

PLACEBO COMPARATOR

Participants will receive a single SC dose of TAK-951 matching placebo on Day 1.

Drug: Placebo

Part 1, Cohort 1: TAK-951 Dose 1

EXPERIMENTAL

Participants will receive a single SC dose of TAK-951 Dose 1 on Day 1.

Drug: TAK-951

Part 1, Cohort 2: TAK-951 Dose 2

EXPERIMENTAL

Participants will receive a single SC dose of TAK-951 Dose 2 on Day 1.

Drug: TAK-951

Part 1, Cohort 3: TAK-951 Dose 3

EXPERIMENTAL

Participants will receive a single SC dose of TAK-951 Dose 3 on Day 1.

Drug: TAK-951

Part 1, Cohort 4: TAK-951 Dose 4

EXPERIMENTAL

Participants will receive a single SC dose of TAK-951 Dose 4 on Day 1.

Drug: TAK-951

Part 1, Cohort 5: TAK-951 Dose 5

EXPERIMENTAL

Participants will receive a single SC dose of TAK-951 Dose 5 on Day 1.

Drug: TAK-951

Part 1, Cohort 6: TAK-951 Dose 6

EXPERIMENTAL

Participants will receive a single SC dose of TAK-951 Dose 6 on Day 1.

Drug: TAK-951

Part 2: TAK-951 Multiple Rising Doses

EXPERIMENTAL

Participants will receive multiple rising SC doses of TAK-951 twice daily (BID) or 3 times a day (TID) in Part 2.

Drug: TAK-951

Part 3: TAK-951 Multiple Dose Titration

EXPERIMENTAL

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.

Drug: TAK-951

Interventions

TAK-951 DRUG

TAK-951 SC injection

Part 1, Cohort 1: TAK-951 Dose 1; Part 1, Cohort 2: TAK-951 Dose 2; Part 1, Cohort 3: TAK-951 Dose 3; Part 1, Cohort 4: TAK-951 Dose 4; Part 1, Cohort 5: TAK-951 Dose 5; Part 1, Cohort 6: TAK-951 Dose 6; Part 2: TAK-951 Multiple Rising Doses; Part 3: TAK-951 Multiple Dose Titration

Placebo DRUG

TAK-951 matching placebo SC injection

Part 1: Pooled Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

You may not qualify if:

• 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.
• The participant is unable to refrain from or anticipates using marijuana or cannabis-containing products beginning approximately 7 days before administration of the first dose of study drug, throughout the study until after the last pharmacokinetic (PK) dose.
• The participant has a history or presence of alcoholism or drug abuse within the past 2 years prior to dosing, or frequent or heavy use (i.e., near-daily) of medical or recreational cannabis in the past 3 months before screening, as determined by the investigator.
• The participant drinks alcohol in excess of 7 drinks/week for women or 14 drinks/week for men (where 1 drink=5 ounces \[150 mL\] of wine or 12 ounces \[360 mL\] of beer or 1.5 ounces \[45 mL\] of hard liquor \[45% alcohol\]) within 3 months before screening.
• The participant has a positive alcohol test or urine drug screen results at screening or check-in.
• The participant has had a previous major psychiatric disorder.
• The participant has a history or presence of:

Sponsors & Collaborators

• Takeda: lead

Study Sites (2)

ICON

Lenexa, Kansas, 66219, United States

Location

ICON

Salt Lake City, Utah, 84124, United States

Location

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2024
• First Posted: September 24, 2024
• Study Start: January 7, 2022
• Primary Completion: September 21, 2023
• Study Completion: September 21, 2023
• Last Updated: November 22, 2024
• Results First Posted: November 22, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (2)