NCT04486950 is a Phase 1 clinical trial of TAK-951 in Healthy Volunteer, sponsored by Takeda.

Who is sponsoring NCT04486950?

NCT04486950 is sponsored by Takeda.

What drugs are being tested in NCT04486950?

Interventions in NCT04486950: TAK-951, TAK-951 Placebo.

What condition does NCT04486950 study?

NCT04486950 studies Healthy Volunteer.

Is NCT04486950 still recruiting?

NCT04486950 is currently completed. Last updated 10 March 2023.

Are results published for NCT04486950?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-03-10 · How we verify

NCT04486950

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of TAK-951 in Healthy Adults

Completed Phase 1 Results posted Last updated 10 March 2023

What this trial tests

Phase 1 trial testing TAK-951 in Healthy Volunteer in 32 participants. Completed in 27 May 2021.

Timeline

7 July 2020

Primary endpoint
16 May 2021

27 May 2021

Quick facts

Lead sponsor	Takeda
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	other
Enrollment	32
Start date	7 July 2020
Primary completion	16 May 2021
Estimated completion	27 May 2021
Sites	1 location across United States

Drugs / interventions tested

TAK-951 — full drug profile →
TAK-951 Placebo

Conditions studied

Healthy Volunteer — all drugs for Healthy Volunteer →

Sponsor

Takeda — full company profile →

Who can join

Adults 19 to 55, any sex, with Healthy Volunteer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Reported One or More Treatment-emergent Adverse Events (TEAEs) Primary · Baseline up to Day 29

Group	Value	95% CI
Cohorts 1 to 2, Treatment P1: Placebo Pooled	1
Cohort 3, Treatment P2: Placebo	0
Cohort 4, Treatment P3: Placebo	1
Cohort 1, Treatment A: TAK-951 20 mcg	3
Cohort 2, Treatment B: TAK-951 1.0 mg	1
Cohort 3, Treatment C: TAK-951 1.0 mg	3
Cohort 4, Treatment D: TAK-951 1.0 mg	1

Number of Participants With Clinically Significant Change From Baseline in Vital Sign Values Primary · Baseline up to Day 2

Group	Value	95% CI
Cohorts 1 to 2, Treatment P1: Placebo Pooled	0
Cohort 3, Treatment P2: Placebo	0
Cohort 4, Treatment P3: Placebo	0
Cohort 1, Treatment A: TAK-951 20 mcg	0
Cohort 2, Treatment B: TAK-951 1.0 mg	0
Cohort 3, Treatment C: TAK-951 1.0 mg	0
Cohort 4, Treatment D: TAK-951 1.0 mg	0

Number of Participants With Clinically Significant Change From Baseline in 12- Lead Electrocardiogram (ECG) Values Primary · Baseline up to Day 2

Group	Value	95% CI
Cohorts 1 to 2, Treatment P1: Placebo Pooled	0
Cohort 3, Treatment P2: Placebo	0
Cohort 4, Treatment P3: Placebo	0
Cohort 1, Treatment A: TAK-951 20 mcg	0
Cohort 2, Treatment B: TAK-951 1.0 mg	0
Cohort 3, Treatment C: TAK-951 1.0 mg	0
Cohort 4, Treatment D: TAK-951 1.0 mg	0

Number of Participants With Clinically Significant Change From Baseline in Laboratory Values Primary · Baseline up to Day 2

Group	Value	95% CI
Cohorts 1 to 2, Treatment P1: Placebo Pooled	0
Cohort 3, Treatment P2: Placebo	0
Cohort 4, Treatment P3: Placebo	0
Cohort 1, Treatment A: TAK-951 20 mcg	0
Cohort 2, Treatment B: TAK-951 1.0 mg	0
Cohort 3, Treatment C: TAK-951 1.0 mg	0
Cohort 4, Treatment D: TAK-951 1.0 mg	0

Number of Participants With Clinically Significant Change From Baseline in Physical Examination Values Primary · Baseline up to Day 29

Group	Value	95% CI
Cohorts 1 to 2, Treatment P1: Placebo Pooled	0
Cohort 3, Treatment P2: Placebo	0
Cohort 4, Treatment P3: Placebo	0
Cohort 1, Treatment A: TAK-951 20 mcg	0
Cohort 2, Treatment B: TAK-951 1.0 mg	0
Cohort 3, Treatment C: TAK-951 1.0 mg	0
Cohort 4, Treatment D: TAK-951 1.0 mg	0

AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-951 Secondary · Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose

Group	Value	95% CI
Cohort 1, Treatment A: TAK-951 20 mcg	2.758	± 25.1
Cohort 2, Treatment B: TAK-951 1.0 mg	110.4	± 11.0
Cohort 3, Treatment C: TAK-951 1.0 mg	127.7	± 23.9
Cohort 4, Treatment D: TAK-951 1.0 mg	133.2	± 9.5

Ceoi: Plasma Concentration at the End of Infusion for TAK-951 Secondary · Day 1: at the end of infusion (at 30 hours post-infusion)

Group	Value	95% CI
Cohort 1, Treatment A: TAK-951 20 mcg	0.5203	± 143.2
Cohort 2, Treatment B: TAK-951 1.0 mg	48.95	± 15.9
Cohort 3, Treatment C: TAK-951 1.0 mg	37.03	± 38.4
Cohort 4, Treatment D: TAK-951 1.0 mg	27.06	± 9.1

AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-951 Secondary · Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose

Group	Value	95% CI
Cohort 1, Treatment A: TAK-951 20 mcg	2.722	± 25.4
Cohort 2, Treatment B: TAK-951 1.0 mg	110.0	± 10.8
Cohort 3, Treatment C: TAK-951 1.0 mg	127.2	± 24.0
Cohort 4, Treatment D: TAK-951 1.0 mg	132.5	± 9.5

T1/2z: Terminal Disposition Phase Half-life for TAK-951 Secondary · Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose

Group	Value	95% CI
Cohort 1, Treatment A: TAK-951 20 mcg	4.025	± 0.7100
Cohort 2, Treatment B: TAK-951 1.0 mg	4.670	± 0.5576
Cohort 3, Treatment C: TAK-951 1.0 mg	4.454	± 0.5124
Cohort 4, Treatment D: TAK-951 1.0 mg	4.640	± 0.3410

λz: Terminal Disposition Phase Rate Constant for TAK-951 Secondary · Day 1 pre-dose and at multiple time points (up to 30 hours) post-dose

Group	Value	95% CI
Cohort 1, Treatment A: TAK-951 20 mcg	0.1781	± 0.040265
Cohort 2, Treatment B: TAK-951 1.0 mg	0.1501	± 0.016879
Cohort 3, Treatment C: TAK-951 1.0 mg	0.1574	± 0.018543
Cohort 4, Treatment D: TAK-951 1.0 mg	0.1500	± 0.010488

Number of Participants With Positive Anti-drug Antibodies (ADA) in Serum Secondary · Baseline up to Day 29

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.

Group	Value	95% CI
Cohorts 1 to 2, Treatment P1: Placebo Pooled	0
Cohort 3, Treatment P2: Placebo	0
Cohort 4, Treatment P3: Placebo	0
Cohort 1, Treatment A: TAK-951 20 mcg	0
Cohort 2, Treatment B: TAK-951 1.0 mg	0
Cohort 3, Treatment C: TAK-951 1.0 mg	0
Cohort 4, Treatment D: TAK-951 1.0 mg	0

Adverse events — posted to ClinicalTrials.gov

Time frame: TEAEs were adverse events that started after the first dose of study drug (Baseline) up to Day 29. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohorts 1 to 2, Treatment P1: Placebo Pooled

Serious: 0/4 (0%)

Deaths: 0/4

Cohort 3, Treatment P2: Placebo

Serious: 0/2 (0%)

Deaths: 0/2

Cohort 4, Treatment P3: Placebo

Serious: 0/2 (0%)

Deaths: 0/2

Cohort 1, Treatment A: TAK-951 20 mcg

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 2, Treatment B: TAK-951 1.0 mg

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 3, Treatment C: TAK-951 1.0 mg

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 4, Treatment D: TAK-951 1.0 mg

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (14 terms — click to expand)

Reaction	System	Cohorts 1 to 2, Treatment …	Cohort 3, Treatment P2: Pl…	Cohort 4, Treatment P3: Pl…	Cohort 1, Treatment A: TAK…	Cohort 2, Treatment B: TAK…	Cohort 3, Treatment C: TAK…	Cohort 4, Treatment D: TAK…
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—
Heart rate increased	Investigations	—	—	—	—	—	—	—
Joint swelling	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Medical device site reaction	General disorders	—	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Orthostatic heart rate response increased	Investigations	—	—	—	—	—	—	—
Palpitations	Cardiac disorders	—	—	—	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—	—	—	—
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Vessel puncture site bruise	General disorders	—	—	—	—	—	—	—
Vessel puncture site pain	General disorders	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT04486950 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of TAK-951

Trials testing the same drug.

NCT06768658 — A Study of TAK-951 in Participants With Cyclic Vomiting Syndrome (CVS) · Phase 1 · terminated
NCT06610279 — A Study of TAK-951 in Healthy Adults · Phase 1 · terminated
NCT04557189 — A Study of TAK-951 to Stop Adults Getting Nausea and Vomiting After Planned Surgery · Phase 2 · completed
NCT05567393 — A Study of TAK-951 in Healthy Adults · Phase 1 · completed

Other recruiting trials for Healthy Volunteer

Currently open trials in the same condition.

NCT06274749 — Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Mask · NA · recruiting
NCT05652478 — Early Metabolic Effects of Antiretroviral Drugs in Healthy volUnteers: a Phase 2 Randomized Study · Phase 2 · recruiting
NCT06845176 — Combining Motor Imagery and Tendon Vibration on the Effectiveness of Motor Imagery · NA · recruiting
NCT07439263 — Single Ascending Dose Study of HB2198 in Healthy Participants · Phase 1 · recruiting
NCT07220122 — Impact of Exogenous Ketones on Breathing in Healthy Volunteers · EARLY_PHASE1 · recruiting

Other Takeda trials

Trials by the same sponsor.

NCT05669729 — A Survey to Assess Participants', Caregivers', and Nurses' Use and Understanding of Educational Material on Velagluceras · not yet recruiting
NCT07403968 — A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease · Phase 2 · not yet recruiting
NCT07293364 — A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema · NA · not yet recruiting
NCT07218393 — A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt · not yet recruiting
NCT07445087 — A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04486950 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 10 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04486950.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04486950

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other trials of TAK-951

Other recruiting trials for Healthy Volunteer

Other Takeda trials

Verify against primary sources