NCT03870555 is a Phase 1 clinical trial of TAK-954 in Healthy Volunteers, sponsored by Millennium Pharmaceuticals, Inc..

Who is sponsoring NCT03870555?

NCT03870555 is sponsored by Millennium Pharmaceuticals, Inc..

What drugs are being tested in NCT03870555?

Interventions in NCT03870555: TAK-954, TAK-954 Placebo.

What condition does NCT03870555 study?

NCT03870555 studies Healthy Volunteers.

Is NCT03870555 still recruiting?

NCT03870555 is currently completed. Last updated 24 June 2020.

Are results published for NCT03870555?

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

Last reviewed 2020-06-24 · How we verify

NCT03870555

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

A Study to Investigate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-954 in Healthy Adult Participants

Completed Phase 1 Results posted Last updated 24 June 2020

What this trial tests

Phase 1 trial testing TAK-954 in Healthy Volunteers in 6 participants. Completed in 16 May 2019.

Timeline

8 March 2019

Primary endpoint
16 May 2019

16 May 2019

Quick facts

Lead sponsor	Millennium Pharmaceuticals, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	other
Enrollment	6
Start date	8 March 2019
Primary completion	16 May 2019
Estimated completion	16 May 2019
Sites	1 location across United States

Drugs / interventions tested

TAK-954 — full drug profile →
TAK-954 Placebo

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Millennium Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Volunteers. 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 Reporting One or More Treatment-emergent Adverse Events (TEAEs) for TAK-954 Primary · Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)

Group	Value	95% CI
Treatment Dose: TAK-954 0.5 mg	4
Treatment Dose: TAK-954 1 mg	3
Treatment Dose: TAK-954 2 mg	0

Number of Participants With Clinically Significant Change From Baseline in Vital Signs for TAK-954 Primary · Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)

Group	Value	95% CI
Treatment Dose: TAK-954 0.5 mg	0
Treatment Dose: TAK-954 1 mg	0
Treatment Dose: TAK-954 2 mg	0

Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiograms (ECG) for TAK-954 Primary · Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)

Group	Value	95% CI
Treatment Dose: TAK-954 0.5 mg	0
Treatment Dose: TAK-954 1 mg	0
Treatment Dose: TAK-954 2 mg	0

Number of Participants With Clinically Notable Shifts From Baseline to Abnormal Post-dose in Clinical Laboratory Values for TAK-954 Primary · Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52)

Group	Value	95% CI
Treatment Dose: TAK-954 0.5 mg	0
Treatment Dose: TAK-954 1 mg	0
Treatment Dose: TAK-954 2 mg	0

AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-954 Primary · Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose

Group	Value	95% CI
Treatment Dose: TAK-954 0.5 mg	88930	± 23.0
Treatment Dose: TAK-954 1 mg	163200	± 12.8
Treatment Dose: TAK-954 2 mg	298400	± 29.6

AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-954 Primary · Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose

Group	Value	95% CI
Treatment Dose: TAK-954 0.5 mg	89220	± 22.8
Treatment Dose: TAK-954 1 mg	163700	± 12.8
Treatment Dose: TAK-954 2 mg	299500	± 29.6

Ceoi: Plasma Concentration Observed at the End of Infusion for TAK-954 Primary · Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose

Group	Value	95% CI
Treatment Dose: TAK-954 0.5 mg	7502	± 24.1
Treatment Dose: TAK-954 1 mg	15260	± 12.9
Treatment Dose: TAK-954 2 mg	30270	± 28.5

CL: Total Clearance After Intravenous Administration for TAK-954 Primary · Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose

Group	Value	95% CI
Treatment Dose: TAK-954 0.5 mg	5.604	± 22.8
Treatment Dose: TAK-954 1 mg	6.110	± 12.8
Treatment Dose: TAK-954 2 mg	6.679	± 29.6

Vz: Volume of Distribution During the Terminal Disposition Phase After Intravenous Administration for TAK-954 Primary · Day 2 pre-dose and at multiple time points (up to 336 hours) post-dose

Group	Value	95% CI
Treatment Dose: TAK-954 0.5 mg	197.9	± 13.7
Treatment Dose: TAK-954 1 mg	387.7	± 45.6
Treatment Dose: TAK-954 2 mg	901.7	± 61.7

Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 12 Hours Post-dose Primary · Day 2 pre-dose and at multiple time points (up to 12 hours) post-dose

Group	Value	95% CI
Treatment Dose: TAK-954 0.5 mg	104300	± 6.3
Treatment Dose: TAK-954 1 mg	226000	± 16.0
Treatment Dose: TAK-954 2 mg	408900	± 15.3

Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 24 Hours Post-dose Primary · Day 2 pre-dose and at multiple time points (up to 24 hours) post-dose

Group	Value	95% CI
Treatment Dose: TAK-954 0.5 mg	53200	± 27.3
Treatment Dose: TAK-954 1 mg	115300	± 19.9
Treatment Dose: TAK-954 2 mg	190700	± 23.7

Ae: Amount of Unchanged Drug Excreted in the Urine for TAK-954 on Day 2 up to 36 Hours Post-dose Primary · Day 2 pre-dose and at multiple time points (up to 36 hours) post-dose

Group	Value	95% CI
Treatment Dose: TAK-954 0.5 mg	32420	± 17.3
Treatment Dose: TAK-954 1 mg	66560	± 5.3
Treatment Dose: TAK-954 2 mg	103600	± 8.5

Adverse events — posted to ClinicalTrials.gov

Time frame: Lead-in Dose: Day 1 of Period 1, 2, and 3; Treatment Dose: Dosing on Day 2 in Period 1 up to 14 days after last dose of study drug on Day 2 of Period 3 (up to Day 52). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Lead-in Dose: TAK-954 0.1 mg

Serious: 0/6 (0%)

Deaths: 0/6

Lead-in Dose: Placebo

Serious: 0/6 (0%)

Deaths: 0/6

Treatment Dose: TAK-954 0.5 mg

Serious: 0/4 (0%)

Deaths: 0/4

Treatment Dose: TAK-954 1 mg

Serious: 0/4 (0%)

Deaths: 0/4

Treatment Dose: TAK-954 2 mg

Serious: 0/3 (0%)

Deaths: 0/3

Treatment Dose: Placebo

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (20 terms — click to expand)

Reaction	System	Lead-in Dose: TAK-954 0.1 mg	Lead-in Dose: Placebo	Treatment Dose: TAK-954 0.…	Treatment Dose: TAK-954 1 mg	Treatment Dose: TAK-954 2 mg	Treatment Dose: Placebo
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Dysgeusia	Nervous system disorders	—	—	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—
Anorectal discomfort	Gastrointestinal disorders	—	—	—	—	—	—
Flatulence	Gastrointestinal disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Catheter site pain	General disorders	—	—	—	—	—	—
Chills	General disorders	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—
Feeling hot	General disorders	—	—	—	—	—	—
Thirst	General disorders	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—
Increased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT03870555 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the safety, tolerability, and PK of single ascending intravenous doses of TAK-954.

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-954

Trials testing the same drug.

NCT03827655 — A Study of TAK-954 to Treat Gastrointestinal Dysfunction in Adults After Surgery · Phase 2 · completed
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NCT03281577 — Effect of TAK-954 on Gastrointestinal and Colonic Transit in Diabetic or Idiopathic Gastroparesis Participants · Phase 2 · completed
NCT03296787 — A Study to Evaluate the Effect of Renal Impairment and Dialysis Treatment on the Pharmacokinetics (PK) of a Single Intra · Phase 1 · completed
NCT03277274 — A Study to Evaluate the Effect of Hepatic Impairment on the Single Dose Pharmacokinetics (PK) of Intravenous TAK-954 · Phase 1 · completed

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

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Other Millennium Pharmaceuticals, Inc. trials

Trials by the same sponsor.

NCT03888534 — Intravenous Ixazomib in Pediatric Participants With Relapsed or Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphob · Phase 1 · withdrawn
NCT04056468 — A Study to Evaluate Pharmacokinetics (PK) and Safety of Oral Mobocertinib in Participants With Moderate or Severe Hepati · Phase 1 · completed
NCT04454918 — Study to Assess Absolute Bioavailability (ABA) of TAK-906 and to Characterize Mass Balance, Pharmacokinetics (PK), Metab · Phase 1 · completed
NCT04056455 — A Study of Mobocertinib Capsules in People With Severe Kidney Problems and People With Healthy Kidneys · Phase 1 · completed
NCT04091438 — A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia · Phase 1 · completed

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 NCT03870555 (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 Millennium Pharmaceuticals, Inc.
Last refreshed: 24 June 2020

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/NCT03870555.

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

NCT03870555

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-954

Other recruiting trials for Healthy Volunteers

Other Millennium Pharmaceuticals, Inc. trials

Verify against primary sources