A Study of TAK-951 in Participants With Cyclic Vomiting Syndrome (CVS)

NCT06768658 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: TAK-951-1501
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of TAK-951 in participants with cyclic vomiting syndrome (CVS). The main aims of this study are as follows:

• To check for side effects from treatment with TAK-951.
• To learn how much TAK-951 participants can receive without getting side effects from it.
• To check how much TAK-951 stays in the blood over time to work out the best dose.
• The dose of TAK-951 will be checked to see how much stays in their blood over time.
• To see if it is possible to give treatment at home. Participants will be given TAK-951 injected just under the skin (subcutaneous or SC).

Conditions

Nausea and Vomitting

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experience at Least One Treatment-emergent Adverse Event (TEAE)

  A TEAE was defined as an adverse event (AE) with an onset that occurs after receiving study drug. An AE was defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with the treatment. An AE could therefore be any unfavorable and unintended sign (example, a clinically significant abnormal vital sign or laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it was considered related to the drug.

  Up to end of study (up to 44 weeks)

Secondary Outcomes (8)

• Number of Participants With Total Response

  Within 2, 4, and 8 hours post-dose

• Number of Participants With Absence of Emesis

  Within 2, 4, and 8 hours post-dose

• Number of Participants With Absence of Significant Nausea

  Within 2, 4, and 8 hours post-dose

• Peak Nausea VRS Score in All Participants

  At 0, 1 and 2 hours post-dose

• Peak Nausea VRS Score in Participants Who Did Not Receive the Rescue Medication Before the Evaluation Timepoint

  At 4 and 8 hours post-dose

Study Arms (2)

Sequence 1 (ABBA): Placebo + TAK-951 4 mg + TAK-951 4 mg + Placebo

EXPERIMENTAL

Participants will receive TAK-951 placebo-matching injection (Treatment A), subcutaneously, single dose on Day 1 in CVS Episode 1 (Period 1), followed by TAK-951 4 milligram (mg) (Treatment B), injection, subcutaneously, single dose, on Day 1 in CVS Episode 2 (Period 2), further followed by TAK-951 4 mg (Treatment B), injection, subcutaneously, single dose on Day 1 in CVS Episode 3 (Period 3), and further followed by TAK-951 placebo-matching injection (Treatment A), subcutaneously, single dose on Day 1 in CVS Episode 4 (Period 4). A washout period of at least 14 days will be maintained between each Period.

Drug: TAK-951; Drug: TAK-951 Placebo

Sequence 2 (BAAB): TAK-951 4 mg + Placebo + Placebo + TAK-951 4 mg

EXPERIMENTAL

Participants will receive TAK-951 4 mg (Treatment B), injection, subcutaneously, single dose on Day 1 in CVS Episode 1 (Period 1), followed by TAK-951 placebo-matching injection (Treatment A), subcutaneously, single dose on Day 1 in CVS Episode 2 (Period 2), further followed by TAK-951 placebo-matching injection (Treatment A), subcutaneously, single dose on Day 1 in CVS Episode 3 (Period 3), and further followed by TAK-951 4 mg (Treatment B), injection, subcutaneously, single dose on Day 1 in CVS Episode 4 (Period 4). A washout period of at least 14 days will be maintained between each Period.

Drug: TAK-951; Drug: TAK-951 Placebo

Interventions

TAK-951 DRUG

TAK-951 subcutaneous injection.

Sequence 1 (ABBA): Placebo + TAK-951 4 mg + TAK-951 4 mg + Placebo; Sequence 2 (BAAB): TAK-951 4 mg + Placebo + Placebo + TAK-951 4 mg

TAK-951 Placebo DRUG

TAK-951 placebo-matching subcutaneous injection.

Sequence 1 (ABBA): Placebo + TAK-951 4 mg + TAK-951 4 mg + Placebo; Sequence 2 (BAAB): TAK-951 4 mg + Placebo + Placebo + TAK-951 4 mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements and is eligible for the study.
• The participant or, when applicable, the participants' legally acceptable representative signs and dates a written or electronic, informed consent form and any required privacy authorization before the initiation of any study procedures.
• The participant is male or female and aged 18 to 50 years, inclusive.
• The participant has at least a 1-year history of CVS diagnosis based on the Rome IV diagnostic criteria.
• The participant has had at least 4 CVS episodes over 6 months before screening during the last 12 months.
• If taking eligible medications prescribed for the prophylaxis of CVS, the participant must be receiving a stable dose for at least 3 months before screening.
• The participant is willing and able to exclusively use the protocol rescue medications if needed.
• The participant has a stereotypic prodrome with onset less than or equal to (\<=) 4 hours before CVS emetic events.
• The participant has a body mass index (BMI) between 18 and 32 kilogram per square meter (kg/m\^2), inclusive.
• A male participant who is nonsterilized and sexually active with a female partner of childbearing potential agrees to use barrier method of contraception (example, condom with or without spermicide) from signing of informed consent throughout the duration of the study and for 30 days after last dose OR a surgically sterile female participant, or females of nonchildbearing potential with laboratory confirmation of postmenopausal status (that is, follicle-stimulating hormone levels greater than (\>) 40 milli-international units per milliliter \[mIU/mL\]) or one of childbearing potential who is sexually active with a nonsterilized male partner agrees to use a highly effective method of contraception from signing of informed consent throughout the duration of the study and for 30 days after the last dose.

You may not qualify if:

• The participant has participated in another interventional study within 4 weeks or 5 half-lives of the investigational study drug, whichever is longer, before the screening visit. The 4-week window will be derived from the date of the last study procedure and/or AE related to the study procedure in the previous study to the screening visit of the current study.
• The participant has potentially received TAK-951 in a previous clinical study, or has previously completed, discontinued, or withdrawn from this study.
• The participant is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (example, spouse, parent, child, sibling) or is unable to provide consent (example, incapacity or potential duress or undue influence on informed consent process).
• The participant has a history of significant multiple and/or severe allergies (example, food, drug, latex allergy) or has had an anaphylactic reaction or significant intolerance (including medication-induced emesis) to prescription or nonprescription drugs or food, or allergic reactions to allowed rescue medication(s).
• The participant has any condition or abnormality (including laboratory abnormalities), current or past, that, in the opinion of the investigator or medical monitor, would compromise the safety of the participant or interfere with or complicate the assessment of signs or symptoms of CVS.
• The participant uses medical or recreational cannabis more than 3 days/week or its usage triggers nausea and/or vomiting.
• The participant has a history of hypotension, autonomic instability, orthostatic hypotension (excluding in the context of concurrent dehydration), postural orthostatic tachycardia syndrome or a history or presence of 2 or more incidents of syncope within the last 5 years before screening.
• Has a history of long corrected QT interval QTc, history of significant cardia arrhythmia, or a history or presence of:
• A family history of unexplained sudden death or channelopathy; or
• Brugada syndrome (that is, right bundle branch block pattern with ST-elevation in leads V1-V3); or
• Second-degree atrioventricular block type 2, third degree atrioventricular block, prolonged QT interval with Fridericia correction method (QTcF) interval, hypokalemia, hypomagnesemia, or conduction abnormalities; or
• Risk factors for Torsade de Pointes (example, heart failure, cardiomyopathy, or family history of Long QT Syndrome); or
• Any clinically significant electrocardiogram (ECG) findings or medical history including: long or short QTcF (over 450 millisecond \[msec\] or less than 360 msec), bifascicular block or QRS greater than or equal to (\>=120) msec or PR interval \> 210 msec at screening; participants with QTcF \>450 msec (up to 470 msec) taking chronic tricyclic antidepressants (\>3 months) may be enrolled after consultation with the medical monitor; or o The participant has a documented history of sinus bradycardia (less than \[\<\] 45 beats per minute \[bpm\]), sinoatrial block or sinus pause \>=3 seconds, or sinus node dysfunction.
• The participant has a history of other cardiovascular disease or cerebrovascular disease as assessed by the investigator including: essential hypertension requiring therapy or a history or presence of cerebrovascular disease such as cardiac valvulopathy, myocardial infarction, or stroke.
• The participant has an average semirecumbent systolic blood pressure (SBP) \< 95 or \>140 or a diastolic blood pressure (DBP) \<65 millimeter of mercury (mmHg) or \>90 mm Hg at screening.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

New Phase Research & Development

Knoxville, Tennessee, 37909-1161, United States

Location

Related Links

• To obtain more information on the study, click this link.

MeSH Terms

Conditions

Nausea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This study was terminated early and only enrolled one participant that received no treatment. Due to concerns that the participant would be at risk of being re-identified and received no treatment, no data were evaluated and collected to be reported in this study.

Results Point of Contact

• Title: Study Director
• Organization: Takeda

TrialDisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 10, 2025
• Study Start: March 2, 2022
• Primary Completion: January 9, 2023
• Study Completion: January 9, 2023
• Last Updated: July 2, 2025
• Results First Posted: February 5, 2025

Record last verified: 2025-06

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 (1)