NCT03228433 is a Phase 1 clinical trial of TAK-418 in Healthy Participants, sponsored by Takeda.

Who is sponsoring NCT03228433?

NCT03228433 is sponsored by Takeda.

What drugs are being tested in NCT03228433?

Interventions in NCT03228433: TAK-418, TAK-418 Placebo.

What condition does NCT03228433 study?

NCT03228433 studies Healthy Participants.

Is NCT03228433 still recruiting?

NCT03228433 is currently completed. Last updated 9 September 2019.

Are results published for NCT03228433?

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

Last reviewed 2019-09-09 · How we verify

NCT03228433

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

A Study to Evaluate Safety, Tolerability and Pharmacokinetics of Ascending Oral Single Dose of TAK-418 in Healthy Participants

Completed Phase 1 Results posted Last updated 9 September 2019

What this trial tests

Phase 1 trial testing TAK-418 in Healthy Participants in 40 participants. Completed in 12 May 2018.

Timeline

21 July 2017

Primary endpoint
12 May 2018

12 May 2018

Quick facts

Lead sponsor	Takeda
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	other
Enrollment	40
Start date	21 July 2017
Primary completion	12 May 2018
Estimated completion	12 May 2018
Sites	1 location across United States

Drugs / interventions tested

TAK-418 — full drug profile →
TAK-418 Placebo — full drug profile →

Conditions studied

Healthy Participants — all drugs for Healthy Participants →

Sponsor

Takeda — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Participants. 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) Primary · Baseline Up to Day 184

Group	Value	95% CI
Cohorts 1-5: Placebo	4
Cohort 1: TAK-418 5 mg	2
Cohort 2: TAK-418 15 mg	2
Cohort 3A: TAK-418 30 mg Fasted	3
Cohort 3B: TAK-418 30 mg Fed	1
Cohort 4: TAK-418 40 mg	3
Cohort 5: TAK-418 60 mg	3

Number of Participants Who Discontinued Due to an Adverse Event (AE) Primary · Baseline Up to Day 184

Group	Value	95% CI
Cohorts 1-5: Placebo	0
Cohort 1: TAK-418 5 mg	0
Cohort 2: TAK-418 15 mg	0
Cohort 3A: TAK-418 30 mg Fasted	0
Cohort 3B: TAK-418 30 mg Fed	0
Cohort 4: TAK-418 40 mg	0
Cohort 5: TAK-418 60 mg	0

Number of Participants Who Meet the Markedly Abnormal Criteria for Neurological Assessment Measurements at Least Once Post Dose Primary · Baseline Up to Day 184

Group	Value	95% CI
Cohorts 1-5: Placebo	0
Cohort 1: TAK-418 5 mg	0
Cohort 2: TAK-418 15 mg	0
Cohort 3A: TAK-418 30 mg Fasted	0
Cohort 3B: TAK-418 30 mg Fed	0
Cohort 4: TAK-418 40 mg	0
Cohort 5: TAK-418 60 mg	0

Number of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post Dose Primary · Baseline Up to Day 184

Group	Value	95% CI
Cohorts 1-5: Placebo	0
Cohort 1: TAK-418 5 mg	0
Cohort 2: TAK-418 15 mg	0
Cohort 3A: TAK-418 30 mg Fasted	0
Cohort 3B: TAK-418 30 mg Fed	0
Cohort 4: TAK-418 40 mg	0
Cohort 5: TAK-418 60 mg	0

Number of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post Dose Primary · Baseline Up to day 184

Diastolic blood pressure less than (<) 50 mmHg

Group	Value	95% CI
Cohorts 1-5: Placebo	0
Cohort 1: TAK-418 5 mg	1
Cohort 2: TAK-418 15 mg	1
Cohort 3A: TAK-418 30 mg Fasted	0
Cohort 3B: TAK-418 30 mg Fed	0
Cohort 4: TAK-418 40 mg	0
Cohort 5: TAK-418 60 mg	0

Systolic blood pressure < 85 mmHg

Group	Value	95% CI
Cohorts 1-5: Placebo	0
Cohort 1: TAK-418 5 mg	0
Cohort 2: TAK-418 15 mg	1
Cohort 3A: TAK-418 30 mg Fasted	0
Cohort 3B: TAK-418 30 mg Fed	1
Cohort 4: TAK-418 40 mg	0
Cohort 5: TAK-418 60 mg	0

Temperature < 35.6 degrees celsius (°C)

Group	Value	95% CI
Cohorts 1-5: Placebo	0
Cohort 1: TAK-418 5 mg	0
Cohort 2: TAK-418 15 mg	0
Cohort 3A: TAK-418 30 mg Fasted	1
Cohort 3B: TAK-418 30 mg Fed	1
Cohort 4: TAK-418 40 mg	1
Cohort 5: TAK-418 60 mg	0

Temperature greater than (>) 37.7 (°C)

Group	Value	95% CI
Cohorts 1-5: Placebo	0
Cohort 1: TAK-418 5 mg	0
Cohort 2: TAK-418 15 mg	0
Cohort 3A: TAK-418 30 mg Fasted	0
Cohort 3B: TAK-418 30 mg Fed	0
Cohort 4: TAK-418 40 mg	0
Cohort 5: TAK-418 60 mg	2

Number of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Parameters at Least Once Post Dose Primary · Baseline Up to Day 14

ECG ventricular rate(Beats/ minute)

Group	Value	95% CI
Cohorts 1-5: Placebo	1
Cohort 1: TAK-418 5 mg	2
Cohort 2: TAK-418 15 mg	1
Cohort 3A: TAK-418 30 mg Fasted	0
Cohort 3B: TAK-418 30 mg Fed	0
Cohort 4: TAK-418 40 mg	0
Cohort 5: TAK-418 60 mg	0

QT interval (Milliseconds)

Group	Value	95% CI
Cohorts 1-5: Placebo	0
Cohort 1: TAK-418 5 mg	1
Cohort 2: TAK-418 15 mg	0
Cohort 3A: TAK-418 30 mg Fasted	0
Cohort 3B: TAK-418 30 mg Fed	0
Cohort 4: TAK-418 40 mg	0
Cohort 5: TAK-418 60 mg	1

AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration of TAK-418F (TAK-418 Free Base) Secondary · Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Group	Value	95% CI
Cohort 1: TAK-418 5 mg	77.3	± 47.1
Cohort 2: TAK-418 15 mg	290.4	± 21.8
Cohort 3A: TAK-418 30 mg Fasted	649.4	± 8.5
Cohort 3B: TAK-418 30 mg Fed	616.2	± 23.1
Cohort 4: TAK-418 40 mg	674.1	± 27.0
Cohort 5: TAK-418 60 mg	1576.3	± 33.5

AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-418F Secondary · Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Group	Value	95% CI
Cohort 1: TAK-418 5 mg	84.9	± 47.4
Cohort 2: TAK-418 15 mg	296.3	± 22.1
Cohort 3A: TAK-418 30 mg Fasted	659.6	± 8.0
Cohort 3B: TAK-418 30 mg Fed	626.0	± 22.7
Cohort 4: TAK-418 40 mg	681.0	± 26.9
Cohort 5: TAK-418 60 mg	1519.9	± 33.3

Cmax: Maximum Observed Plasma Concentration for TAK-418F Secondary · Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Group	Value	95% CI
Cohort 1: TAK-418 5 mg	21.54	± 35.9
Cohort 2: TAK-418 15 mg	61.90	± 26.6
Cohort 3A: TAK-418 30 mg Fasted	163.64	± 20.9
Cohort 3B: TAK-418 30 mg Fed	94.93	± 33.8
Cohort 4: TAK-418 40 mg	155.32	± 34.3
Cohort 5: TAK-418 60 mg	321.52	± 14.1

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-418F Secondary · Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

The pharmacokinetic analysis set included all participants who received at least 1 dose of study drug and had at least one measurable plasma concentration or amount of drug in urine for TAK-418-F.

Group	Value	95% CI
Cohort 1: TAK-418 5 mg	1.000	0.98 – 1.02
Cohort 2: TAK-418 15 mg	1.000	1.00 – 2.00
Cohort 3A: TAK-418 30 mg Fasted	1.000	0.50 – 1.00
Cohort 3B: TAK-418 30 mg Fed	3.000	1.50 – 3.02
Cohort 4: TAK-418 40 mg	1.250	1.00 – 1.52
Cohort 5: TAK-418 60 mg	1.000	1.00 – 1.00

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of the study drug up to Day 184. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohorts 1-5: Placebo

Serious: 0/10 (0%)

Deaths: 0/10

Cohort 1: TAK-418 5 mg

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 2: TAK-418 15 mg

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 3A: TAK-418 30 mg Fasted

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 3B: TAK-418 30 mg Fed

Serious: 0/5 (0%)

Deaths: 0/5

Cohort 4: TAK-418 40 mg

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 5: TAK-418 60 mg

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (20 terms — click to expand)

Reaction	System	Cohorts 1-5: Placebo	Cohort 1: TAK-418 5 mg	Cohort 2: TAK-418 15 mg	Cohort 3A: TAK-418 30 mg F…	Cohort 3B: TAK-418 30 mg Fed	Cohort 4: TAK-418 40 mg	Cohort 5: TAK-418 60 mg
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—
Eye irritation	Eye disorders	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—
Dental caries	Gastrointestinal disorders	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—
Groin pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Limb discomfort	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—	—	—	—
Testicular pain	Reproductive system and breast disorders	—	—	—	—	—	—	—
Erectile dysfunction	Reproductive system and breast disorders	—	—	—	—	—	—	—
Nasal congestion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Dermatitis contact	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Dry skin	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Night sweats	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT03228433 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the safety and tolerability of TAK-418 following single oral doses in healthy participants.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Targeting epigenetic regulators to overcome drug resistance in cancers.
Wang N, Ma T, Yu B, Yu B. · · 2023 · cited 213× · PMID 36797239 · DOI 10.1038/s41392-023-01341-7
Epigenetics-targeted drugs: current paradigms and future challenges.
Dai W, Qiao X, Fang Y, Guo R, et al · · 2024 · cited 131× · PMID 39592582 · DOI 10.1038/s41392-024-02039-0
Targeting epigenetic regulators for inflammation: Mechanisms and intervention therapy.
Zhang S, Meng Y, Zhou L, Qiu L, et al · · 2022 · cited 48× · PMID 36176733 · DOI 10.1002/mco2.173
LSD1 enzyme inhibitor TAK-418 unlocks aberrant epigenetic machinery and improves autism symptoms in neurodevelopmental disorder models.
Baba R, Matsuda S, Arakawa Y, Yamada R, et al · · 2021 · cited 34× · PMID 33712455 · DOI 10.1126/sciadv.aba1187
Safety, pharmacokinetics and pharmacodynamics of TAK-418, a novel inhibitor of the epigenetic modulator lysine-specific demethylase 1A.
Yin W, Arkilo D, Khudyakov P, Hazel J, et al · · 2021 · cited 16× · PMID 33990969 · DOI 10.1111/bcp.14912
Biological and therapeutic role of LSD1 in Alzheimer's diseases.
Li Y, Zhao Y, Li X, Zhai L, et al · · 2022 · cited 12× · PMID 36386192 · DOI 10.3389/fphar.2022.1020556
Unraveling the relationship between histone methylation and nonalcoholic fatty liver disease.
Xu L, Fan YH, Zhang XJ, Bai L. · · 2024 · cited 3× · PMID 38818286 · DOI 10.4254/wjh.v16.i5.703
CoREST in pieces: Dismantling the CoREST complex for cancer therapy and beyond.
Ismail H, Chagraoui J, Sauvageau G. · · 2025 · cited 2× · PMID 40479062 · DOI 10.1126/sciadv.ads6556

Verify or expand the search:

Other trials of TAK-418

Trials testing the same drug.

NCT04202497 — A Study With [18F]MNI-1054 to Determine Lysine -Specific Demethylase 1A (LSD1) Brain Enzyme Occupancy of TAK-418 After S · Phase 1 · terminated
NCT03501069 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single and Multiple Or · Phase 1 · terminated

Other recruiting trials for Healthy Participants

Currently open trials in the same condition.

NCT07469085 — A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SV003 in Healthy Partici · Phase 1 · recruiting
NCT07503990 — Effects of Food Intake Sequence on Substrate Utilisation and Endurance Performance · NA · recruiting
NCT07474987 — Portable VR-based Chromatic Pupilloperimeter for Diagnosis and Monitoring of Traumatic Brain Injury · recruiting
NCT07511205 — A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD1043 in Healthy Adult Participa · Phase 1 · recruiting
NCT07448155 — A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of INCA033989 Following Subcutaneous or Intravenous A · Phase 1 · active not 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 NCT03228433 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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: 9 September 2019

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/NCT03228433.

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

NCT03228433

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-418

Other recruiting trials for Healthy Participants

Other Takeda trials

Verify against primary sources