Healthy VolunteerPhase 1NCT04486950

A Study of TAK-951 in Healthy Adults

A Phase 1 study testing TAK-951 in people with Healthy Volunteer, run by Takeda at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer
What is being tested?: TAK-951
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 7 Jul 2020to 27 May 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Show all 23Show fewer

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.
Positive urine drug or alcohol results at screening or check-in.
Positive urine cotinine at screening or check-in.
Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
Unable to refrain from or anticipates the use of any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to dosing and throughout the study. Thyroid hormone replacement medication may be permitted if the participant has been on same stable dose for the last 3 months prior to study drug administration. After dosing, acetaminophen (up to 2 g per 24 hours) may be administered at the discretion of the Investigator or designee. Hormone replacement therapy will also be allowed.
Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to dosing and throughout the study.
Donation of blood or significant blood loss within 56 days prior to dosing.
Plasma donation within 7 days prior to dosing.
Has positive results for Coronavirus disease 2019 (COVID-19) testing at screening or check-in.

Trial locations and contacts

1 site in 1 country.

United States1 site

Celerion
Lincoln, Nebraska, 68502

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-951 in Healthy Subjects Following Intravenous Administration

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.

Read the detailed description

The drug being tested in this study is called TAK-951. The study will evaluate the safety, tolerability and PK of TAK-951 in healthy participants.

The study will enroll approximately 40 healthy participants. Each cohort will have 8 participants to be randomized and a minimum of 3 cohorts will be evaluated. Participants will be randomly assigned (by chance, like flipping a coin) to receive TAK-951 or placebo in a 6:2 ratio in one of the following 3 cohorts, which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

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

Sentinel dosing will be done in first 2 participants in each cohort. The dosing in rest of the cohort will done if there are no significant safety or tolerability concerns. Additional 2 cohorts, each cohort with 8 participants may be added in study to evaluate additional intravenous dosing regimen after clinical data analysis of first 3 cohorts. Dosing of the subsequent cohort will be based on the analysis of the previous cohort's data.

This single-center trial will be conducted in the United States. The overall time to participate in this study is up to 57 days. All participants will return to clinic after 14 and 28 days after the last visit to the clinic for a follow-up assessment.

Conditions: Healthy Volunteer
Being tested: TAK-951, TAK-951 Placebo
Keywords: Drug Therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TAK-951Drug
TAK-951 intravenous infusion.
TAK-951 PlaceboDrug
TAK-951 placebo-matching intravenous infusion.

Study groups in NCT04486950
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Drug: TAK-951; Drug: TAK-951 Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Reported One or More Treatment-emergent Adverse Events (TEAEs)
Measured: Baseline up to Day 29
Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values
Measured: Baseline up to Day 2
Number of Participants With Clinically Significant Change From Baseline in 12- Lead Electrocardiogram (ECG) Values
Measured: Baseline up to Day 2
Number of Participants With Clinically Significant Change From Baseline in Laboratory Values
Measured: Baseline up to Day 2
Number of Participants With Clinically Significant Change From Baseline in Physical Examination Values
Measured: Baseline up to Day 29

Secondary outcomes (6)

AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-951
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose
λz: Terminal Disposition Phase Rate Constant for TAK-951
Measured: Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose
Number of Participants With Positive Anti-drug Antibodies (ADA) in Serum
ADA positive was defined as a sample that was evaluated as positive in both the ADA screening and confirmatory assays. ADA positive participants was defined as participants who had at least 1 positive ADA result.
Measured: Baseline up to Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jul 202027 May 2021

First posted27 Jul 2020
Study start7 Jul 2020
Primary completion16 May 2021
Study completion27 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteerStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04486950
Sponsor's protocol ID: TAK-951-1004
Other IDs: U1111-1251-9214
Status last verified: Feb 2023
First submitted: 22 Jul 2020
Last updated: 10 Mar 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TAK-951 in Healthy Subjects Following Intravenous Administration
ClinicalTrials.gov ID: NCT04486950
Acronym / sponsor ID: TAK-951-1004
Conditions: Healthy Volunteer
Keywords: Drug Therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 7 Jul 2020 (actual)
Primary completion: 16 May 2021 (actual)
Study completion: 27 May 2021 (actual)
First posted: 27 Jul 2020 (actual)
Results: Posted 10 Mar 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

The drug being tested in this study is called TAK-951. The study will evaluate the safety, tolerability and PK of TAK-951 in healthy participants.

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Cohort 1 (Low Dose): TAK-951 20 mcg Infusion Over 60 Minutes	Experimental	Drug: TAK-951, Drug: TAK-951 PlaceboTAK-951 20 microgram (mcg) or TAK-951 placebo-matching, infusion, intravenously, over a period of 60 minutes on Day 1.
Cohort 2 (High Dose): TAK-951 1 mg Infusion Over 60 Minutes	Experimental	Drug: TAK-951, Drug: TAK-951 PlaceboTAK-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.
Cohort 3: TAK-951 1 mg Infusion Over 120 Minutes	Experimental	Drug: TAK-951, Drug: TAK-951 PlaceboTAK-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.

Who may qualify

Ages: 19 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (23 listed)

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:
Semi-recumbent blood pressure (average of duplicate) is less than 90/60 millimeter of mercury (mmHg) or greater than 140/90 mmHg at screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TAK-951TAK-951 intravenous infusion.	Drug	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 PlaceboTAK-951 placebo-matching intravenous infusion.	Drug	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

Primary outcome

Number of Participants Who Reported One or More Treatment-emergent Adverse Events (TEAEs)
Time frame: Baseline up to Day 29
Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values
Time frame: Baseline up to Day 2
Number of Participants With Clinically Significant Change From Baseline in 12- Lead Electrocardiogram (ECG) Values
Time frame: Baseline up to Day 2
Number of Participants With Clinically Significant Change From Baseline in Laboratory Values
Time frame: Baseline up to Day 2
Number of Participants With Clinically Significant Change From Baseline in Physical Examination Values
Time frame: Baseline up to Day 29

6 secondary outcomes

AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-951
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose
λz: Terminal Disposition Phase Rate Constant for TAK-951
Time frame: Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose
Number of Participants With Positive Anti-drug Antibodies (ADA) in Serum
Time frame: Baseline up to Day 29

Results and safety

Results posted to the registry on 10 Mar 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohorts 1 to 2, Treatment P1: Placebo Pooled	4	4
Cohort 3, Treatment P2: Placebo	2	2
Cohort 4, Treatment P3: Placebo	2	2
Cohort 1, Treatment A: TAK-951 20 mcg	6	6
Cohort 2, Treatment B: TAK-951 1.0 mg	6	6
Cohort 3, Treatment C: TAK-951 1.0 mg	6	5
Cohort 4, Treatment D: TAK-951 1.0 mg	6	6

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

Time frame: Baseline up to Day 29. Count of participants. Unit: Participants

Measure	Cohorts 1 to 2, Treatment P1: Placebo Pooled n = 4	Cohort 3, Treatment P2: Placebo n = 2	Cohort 4, Treatment P3: Placebo n = 2	Cohort 1, Treatment A: TAK-951 20 mcg n = 6	Cohort 2, Treatment B: TAK-951 1.0 mg n = 6	Cohort 3, Treatment C: TAK-951 1.0 mg n = 6	Cohort 4, Treatment D: TAK-951 1.0 mg n = 6
Value	1	0	1	3	1	3	1

Population analysed: The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.

Primary outcome: Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values

Time frame: Baseline up to Day 2. Count of participants. Unit: Participants

Measure	Cohorts 1 to 2, Treatment P1: Placebo Pooled n = 4	Cohort 3, Treatment P2: Placebo n = 2	Cohort 4, Treatment P3: Placebo n = 2	Cohort 1, Treatment A: TAK-951 20 mcg n = 6	Cohort 2, Treatment B: TAK-951 1.0 mg n = 6	Cohort 3, Treatment C: TAK-951 1.0 mg n = 6	Cohort 4, Treatment D: TAK-951 1.0 mg n = 6
Value	0	0	0	0	0	0	0

Population analysed: The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.

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

Time frame: Baseline up to Day 2. Count of participants. Unit: Participants

Measure	Cohorts 1 to 2, Treatment P1: Placebo Pooled n = 4	Cohort 3, Treatment P2: Placebo n = 2	Cohort 4, Treatment P3: Placebo n = 2	Cohort 1, Treatment A: TAK-951 20 mcg n = 6	Cohort 2, Treatment B: TAK-951 1.0 mg n = 6	Cohort 3, Treatment C: TAK-951 1.0 mg n = 6	Cohort 4, Treatment D: TAK-951 1.0 mg n = 6
Value	0	0	0	0	0	0	0

Population analysed: The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.

Primary outcome: Number of Participants With Clinically Significant Change From Baseline in Laboratory Values

Time frame: Baseline up to Day 2. Count of participants. Unit: Participants

Measure	Cohorts 1 to 2, Treatment P1: Placebo Pooled n = 4	Cohort 3, Treatment P2: Placebo n = 2	Cohort 4, Treatment P3: Placebo n = 2	Cohort 1, Treatment A: TAK-951 20 mcg n = 6	Cohort 2, Treatment B: TAK-951 1.0 mg n = 6	Cohort 3, Treatment C: TAK-951 1.0 mg n = 6	Cohort 4, Treatment D: TAK-951 1.0 mg n = 6
Value	0	0	0	0	0	0	0

Population analysed: The safety analysis set consisted of all participants who were enrolled and received the full or partial dose of study drug or placebo.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohorts 1 to 2, Treatment P1: Placebo Pooled	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Cohort 3, Treatment P2: Placebo	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Cohort 4, Treatment P3: Placebo	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Cohort 1, Treatment A: TAK-951 20 mcg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Cohort 2, Treatment B: TAK-951 1.0 mg	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Cohort 3, Treatment C: TAK-951 1.0 mg	0 of 6 (0%)	3 of 6 (50%)	0 of 6
Cohort 4, Treatment D: TAK-951 1.0 mg	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain more information on the study, click here/on this linkLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director study director

Takeda

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TAK-951 in people with Healthy Volunteer, run by Takeda at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Reported One or More Treatment-emergent Adverse Events (TEAEs) (time frame: Baseline up to Day 29). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04486950.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.