A Study of TAK-951 in Healthy Adults

NCT04486950 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: TAK-951-1004U1111-1251-9214
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

It is hoped that a medicine called TAK-951 will eventually be used to treat nausea and vomiting. Before then, the sponsor needs to understand how the body processes TAK-951 in healthy adults. The main aims of this study are as follows:

• To check for side effects from TAK-951 when given at a slow and fast infusion rate.
• To learn how much TAK-951 participants can receive without getting side effects from it. Participants will receive a single infusion of either TAK-951 or placebo. In this study, a placebo looks like TAK-951 but does not have any medicine in it. Participants will receive either a low dose or high dose of TAK-951. The infusion will take from 1-3 hours. Participants will stay in the study clinic for about 4 days to receive the study medicine (TAK-951 or placebo) and check for side effects. They will have follow-up visits at the clinic about 2 weeks and 4 weeks after treatment.

Conditions

Healthy Volunteer

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (5)

• Number of Participants Who Reported One or More Treatment-emergent Adverse Events (TEAEs)

  Baseline up to Day 29

• Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values

  Baseline up to Day 2

• Number of Participants With Clinically Significant Change From Baseline in 12- Lead Electrocardiogram (ECG) Values

  Baseline up to Day 2

• Number of Participants With Clinically Significant Change From Baseline in Laboratory Values

  Baseline up to Day 2

• Number of Participants With Clinically Significant Change From Baseline in Physical Examination Values

  Baseline up to Day 29

Secondary Outcomes (6)

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

  Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose

• Ceoi: Plasma Concentration at the End of Infusion for TAK-951

  Day 1: at the end of infusion (at 30 hours post-infusion)

• AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-951

  Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose

• T1/2z: Terminal Disposition Phase Half-life for TAK-951

  Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose

• λz: Terminal Disposition Phase Rate Constant for TAK-951

  Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose

Study Arms (3)

Cohort 1 (Low Dose): TAK-951 20 mcg Infusion Over 60 Minutes

EXPERIMENTAL

TAK-951 20 microgram (mcg) or TAK-951 placebo-matching, infusion, intravenously, over a period of 60 minutes on Day 1.

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

Cohort 2 (High Dose): TAK-951 1 mg Infusion Over 60 Minutes

EXPERIMENTAL

TAK-951 1 milligram (mg) or TAK-951 placebo-matching, infusion, intravenously, over a period of 60 minutes on Day 1. Dose level will be determined based on safety, tolerability and PK data from previous cohorts.

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

Cohort 3: TAK-951 1 mg Infusion Over 120 Minutes

EXPERIMENTAL

TAK-951 1 mg or TAK-951 placebo-matching, infusion, intravenously, over a period of 120 minutes on Day 1. Dose level will be determined based on safety, tolerability and PK data from previous cohorts.

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

Interventions

TAK-951 DRUG

TAK-951 intravenous infusion.

Cohort 1 (Low Dose): TAK-951 20 mcg Infusion Over 60 Minutes; Cohort 2 (High Dose): TAK-951 1 mg Infusion Over 60 Minutes; Cohort 3: TAK-951 1 mg Infusion Over 120 Minutes

TAK-951 Placebo DRUG

TAK-951 placebo-matching intravenous infusion.

Cohort 1 (Low Dose): TAK-951 20 mcg Infusion Over 60 Minutes; Cohort 2 (High Dose): TAK-951 1 mg Infusion Over 60 Minutes; Cohort 3: TAK-951 1 mg Infusion Over 120 Minutes

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Continuous non-smoker who has not used nicotine- and tobacco-containing products and/or cannabis products for at least 3 months prior to dosing and throughout the study.
• Body mass index (BMI) greater than or equal to (\>=) 18.0 and less than or equal to (\<=) 32.0 kilogram per square meter (kg/m\^2) at screening.
• Female must be of non-childbearing potential.

You may not qualify if:

• Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.
• Drink alcohol in excess of 21 glasses/units per week for males or 14 glasses/units per week for females, with one unit equal to (=) 150 milliliter (mL) of wine or 360 mL of beer or 45 mL of 45 percent (%) alcohol.
• Have any tattoos, scars or skin issue at planned IV infusion site which could interfere with dosing.
• History or presence of:
• Three (3) or more incidences of vasovagal syncope within the last 5 years prior to screening.
• Family history of unexplained sudden death or channelopathy.
• Brugada syndrome (that is, right bundle branch block (RBBB) pattern with ST-elevation in leads V1-V3).
• Cardiovascular or cerebrovascular disease, such as cardiac valvulopathy, myocardial infarction, stroke, sick sinus syndrome, pulmonary congestion, symptomatic or significant cardiac arrhythmia, second-degree AV block type 2, third-degree AV block, prolonged corrected QT interval by Fredericia (QTcF) interval, hypokalemia, hypomagnesemia, or conduction abnormalities;
• Risk factors for Torsade de Pointes (example, heart failure, cardiomyopathy, or family history of Long QT Syndrome);
• Any clinically significant ECG findings or medical history including: long or short QT interval with QTcF (over 450 msec or less than 360 msec), bifascicular block or QRS \>=120 msec or PR interval greater than (\>) 200 msec at screening or Day -1 pre-Hour 0.
• Documented history of sinoatrial block or sinus pause \>=3 seconds.
• Semi-recumbent blood pressure (average of duplicate) is less than 90/60 millimeter of mercury (mmHg) or greater than 140/90 mmHg at screening.
• Has an average semi-recumbent heart rate \<60 or \>100 beats per minute (bpm) (at screening, at Day -1 pre-Hour 0, or at pre-dose Day 1); athletic participants with an average semi-recumbent heart rate \<60 bpm can be enrolled only with medical monitor approval. If participant has heart rate \<60 bpm Investigator should obtain medical approval from Sponsor.
• Has orthostatic hypotension defined as a decrease in systolic blood pressure \>=20 mmHg or a decrease in diastolic blood pressure \>=10 mmHg after 2 minutes of standing when compared with blood pressure from the semi-recumbent position at screening and at Day -1 pre-Hour 0. The semi-recumbent blood pressure will be an average of duplicate measurements.
• Has postural orthostatic tachycardia, defined as an increase of 30 bpm or heart rate \>120 bpm after standing for 2 minutes.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Related Links

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

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
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2020
• First Posted: July 27, 2020
• Study Start: July 7, 2020
• Primary Completion: May 16, 2021
• Study Completion: May 27, 2021
• Last Updated: March 10, 2023
• Results First Posted: March 10, 2023

Record last verified: 2023-02

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)