NCT03085836 is a Phase 1 clinical trial of TAK-438 in Healthy Participants, sponsored by Takeda.

Who is sponsoring NCT03085836?

NCT03085836 is sponsored by Takeda.

What drugs are being tested in NCT03085836?

Interventions in NCT03085836: TAK-438.

What condition does NCT03085836 study?

NCT03085836 studies Healthy Participants.

Is NCT03085836 still recruiting?

NCT03085836 is currently completed. Last updated 30 January 2019.

Are results published for NCT03085836?

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

Last reviewed 2019-01-30 · How we verify

NCT03085836

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

A Pharmacokinetic Study of TAK-438 in Healthy Adult Chinese Participants

Completed Phase 1 Results posted Last updated 30 January 2019

What this trial tests

Phase 1 trial testing TAK-438 in Healthy Participants in 33 participants. Completed in 17 August 2017.

Timeline

19 April 2017

Primary endpoint
17 August 2017

17 August 2017

Quick facts

Lead sponsor	Takeda
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	33
Start date	19 April 2017
Primary completion	17 August 2017
Estimated completion	17 August 2017
Sites	1 location across China

Drugs / interventions tested

TAK-438 — full drug profile →

Conditions studied

Healthy Participants — all drugs for Healthy Participants →

Sponsor

Takeda — full company profile →

Who can join

Adults 18 to 45, 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.

Cmax: Maximum Observed Plasma Concentration for Free Base of TAK-438 (TAK-438F) and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 Primary · Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose

TAK-438F

Group	Value	95% CI
TAK-438 10 mg Once Daily	9.148	± 2.9972
TAK-438 20 mg Once Daily	18.18	± 4.4973
TAK-438 20 mg Twice Daily	25.23	± 10.017

M-I

Group	Value	95% CI
TAK-438 10 mg Once Daily	38.32	± 8.6143
TAK-438 20 mg Once Daily	67.95	± 23.388
TAK-438 20 mg Twice Daily	59.02	± 18.443

M-II

Group	Value	95% CI
TAK-438 10 mg Once Daily	2.840	± 1.0442
TAK-438 20 mg Once Daily	5.155	± 2.7868
TAK-438 20 mg Twice Daily	4.879	± 2.2426

M-III

Group	Value	95% CI
TAK-438 10 mg Once Daily	15.42	± 3.7788
TAK-438 20 mg Once Daily	25.63	± 7.8650
TAK-438 20 mg Twice Daily	25.67	± 5.9219

M-IV-Sul

Group	Value	95% CI
TAK-438 10 mg Once Daily	28.29	± 5.0563
TAK-438 20 mg Once Daily	60.67	± 16.499
TAK-438 20 mg Twice Daily	42.28	± 9.1174

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 Primary · Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose

TAK-438F

Group	Value	95% CI
TAK-438 10 mg Once Daily	1.750	1.00 – 4.02
TAK-438 20 mg Once Daily	2.000	0.750 – 4.00
TAK-438 20 mg Twice Daily	2.500	0.750 – 4.00

M-I

Group	Value	95% CI
TAK-438 10 mg Once Daily	1.500	0.750 – 2.00
TAK-438 20 mg Once Daily	1.500	0.750 – 3.00
TAK-438 20 mg Twice Daily	2.000	1.00 – 4.00

M-II

Group	Value	95% CI
TAK-438 10 mg Once Daily	4.010	3.00 – 10.0
TAK-438 20 mg Once Daily	6.000	3.00 – 10.0
TAK-438 20 mg Twice Daily	10.00	3.00 – 12.0

M-III

Group	Value	95% CI
TAK-438 10 mg Once Daily	1.750	1.00 – 2.00
TAK-438 20 mg Once Daily	2.000	1.50 – 3.00
TAK-438 20 mg Twice Daily	2.000	1.50 – 4.00

M-IV-Sul

Group	Value	95% CI
TAK-438 10 mg Once Daily	1.500	1.00 – 2.00
TAK-438 20 mg Once Daily	1.500	1.50 – 3.00
TAK-438 20 mg Twice Daily	2.000	1.50 – 3.00

AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 Primary · Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose

TAK-438F

Group	Value	95% CI
TAK-438 10 mg Once Daily	84.38	± 29.197
TAK-438 20 mg Once Daily	188.1	± 43.066
TAK-438 20 mg Twice Daily	226.8	± 67.128

M-I

Group	Value	95% CI
TAK-438 10 mg Once Daily	305.7	± 88.227
TAK-438 20 mg Once Daily	617.2	± 213.56
TAK-438 20 mg Twice Daily	578.7	± 144.15

M-II

Group	Value	95% CI
TAK-438 10 mg Once Daily	52.97	± 22.843
TAK-438 20 mg Once Daily	106.3	± 74.306
TAK-438 20 mg Twice Daily	117.8	± 41.170

M-III

Group	Value	95% CI
TAK-438 10 mg Once Daily	92.83	± 34.769
TAK-438 20 mg Once Daily	178.7	± 64.779
TAK-438 20 mg Twice Daily	193.7	± 56.808

M-IV-Sul

Group	Value	95% CI
TAK-438 10 mg Once Daily	132.5	± 44.602
TAK-438 20 mg Once Daily	307.5	± 89.884
TAK-438 20 mg Twice Daily	240.8	± 82.555

AUCτ: Area Under the Plasma Concentration-time Curve From Time 0 to Tau Over the Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 Primary · Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose

TAK-438F

Group	Value	95% CI
TAK-438 10 mg Once Daily	74.91	± 24.835
TAK-438 20 mg Once Daily	168.6	± 37.455
TAK-438 20 mg Twice Daily	154.8	± 38.920

M-I

Group	Value	95% CI
TAK-438 10 mg Once Daily	251.4	± 77.758
TAK-438 20 mg Once Daily	528.8	± 182.62
TAK-438 20 mg Twice Daily	344.1	± 91.089

M-II

Group	Value	95% CI
TAK-438 10 mg Once Daily	31.77	± 18.646
TAK-438 20 mg Once Daily	79.07	± 56.206
TAK-438 20 mg Twice Daily	41.55	± 19.189

M-III

Group	Value	95% CI
TAK-438 10 mg Once Daily	87.98	± 31.136
TAK-438 20 mg Once Daily	169.2	± 59.474
TAK-438 20 mg Twice Daily	149.1	± 36.714

M-IV-Sul

Group	Value	95% CI
TAK-438 10 mg Once Daily	127.1	± 43.648
TAK-438 20 mg Once Daily	296.0	± 86.359
TAK-438 20 mg Twice Daily	192.8	± 57.176

T1/2z: Terminal Disposition Half-life for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 Primary · Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose

TAK-438F

Group	Value	95% CI
TAK-438 10 mg Once Daily	7.879	± 1.2352
TAK-438 20 mg Once Daily	6.996	± 1.0110
TAK-438 20 mg Twice Daily	7.116	± 0.71638

M-I

Group	Value	95% CI
TAK-438 10 mg Once Daily	10.82	± 4.0923
TAK-438 20 mg Once Daily	8.256	± 1.2964
TAK-438 20 mg Twice Daily	8.385	± 0.73316

M-II

Group	Value	95% CI
TAK-438 10 mg Once Daily	10.52	± 4.3311
TAK-438 20 mg Once Daily	10.37	± 2.9973
TAK-438 20 mg Twice Daily	12.29	± 4.0538

M-III

Group	Value	95% CI
TAK-438 10 mg Once Daily	6.695	± 1.3786
TAK-438 20 mg Once Daily	6.335	± 1.1833
TAK-438 20 mg Twice Daily	6.791	± 0.89228

M-IV-Sul

Group	Value	95% CI
TAK-438 10 mg Once Daily	4.753	± 2.4430
TAK-438 20 mg Once Daily	5.698	± 1.2625
TAK-438 20 mg Twice Daily	5.521	± 2.2225

Cmax,ss: Maximum Observed Plasma Concentration, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 Primary · Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose

TAK-438F

Group	Value	95% CI
TAK-438 10 mg Once Daily	11.01	± 3.4863
TAK-438 20 mg Once Daily	23.43	± 6.1433
TAK-438 20 mg Twice Daily	37.88	± 10.910

M-I

Group	Value	95% CI
TAK-438 10 mg Once Daily	43.39	± 9.6528
TAK-438 20 mg Once Daily	79.85	± 22.119
TAK-438 20 mg Twice Daily	59.55	± 15.512

M-II

Group	Value	95% CI
TAK-438 10 mg Once Daily	3.558	± 1.4983
TAK-438 20 mg Once Daily	6.554	± 2.6078
TAK-438 20 mg Twice Daily	9.174	± 2.8376

M-III

Group	Value	95% CI
TAK-438 10 mg Once Daily	16.62	± 4.1919
TAK-438 20 mg Once Daily	30.15	± 7.3228
TAK-438 20 mg Twice Daily	33.01	± 6.1638

M-IV-Sul

Group	Value	95% CI
TAK-438 10 mg Once Daily	25.33	± 3.6619
TAK-438 20 mg Once Daily	54.08	± 13.927
TAK-438 20 mg Twice Daily	39.74	± 7.1405

Tmax, ss: Time to Reach the Maximum Plasma Concentration (Cmax) at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 Primary · Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose

TAK-438F

Group	Value	95% CI
TAK-438 10 mg Once Daily	1.500	0.750 – 3.02
TAK-438 20 mg Once Daily	2.000	0.750 – 3.00
TAK-438 20 mg Twice Daily	3.000	0.750 – 4.00

M-I

Group	Value	95% CI
TAK-438 10 mg Once Daily	1.500	0.750 – 2.02
TAK-438 20 mg Once Daily	1.000	0.750 – 2.00
TAK-438 20 mg Twice Daily	2.500	1.00 – 10.0

M-II

Group	Value	95% CI
TAK-438 10 mg Once Daily	4.000	3.00 – 6.00
TAK-438 20 mg Once Daily	3.000	3.00 – 10.0
TAK-438 20 mg Twice Daily	3.500	0.00 – 10.0

M-III

Group	Value	95% CI
TAK-438 10 mg Once Daily	1.750	1.00 – 3.00
TAK-438 20 mg Once Daily	2.000	1.50 – 3.00
TAK-438 20 mg Twice Daily	3.000	1.50 – 4.00

M-IV-Sul

Group	Value	95% CI
TAK-438 10 mg Once Daily	2.000	1.00 – 3.00
TAK-438 20 mg Once Daily	1.500	1.50 – 2.00
TAK-438 20 mg Twice Daily	3.000	1.50 – 4.00

AUCτ,ss: Area Under the Plasma Concentration-time Curve During a Dosing Interval, at Steady State for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 Primary · Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose

TAK-438F

Group	Value	95% CI
TAK-438 10 mg Once Daily	93.90	± 28.053
TAK-438 20 mg Once Daily	212.7	± 57.214
TAK-438 20 mg Twice Daily	273.4	± 71.830

M-I

Group	Value	95% CI
TAK-438 10 mg Once Daily	285.5	± 77.884
TAK-438 20 mg Once Daily	581.1	± 198.14
TAK-438 20 mg Twice Daily	435.3	± 92.064

M-II

Group	Value	95% CI
TAK-438 10 mg Once Daily	46.31	± 24.298
TAK-438 20 mg Once Daily	105.5	± 51.688
TAK-438 20 mg Twice Daily	100.4	± 27.966

M-III

Group	Value	95% CI
TAK-438 10 mg Once Daily	95.94	± 29.719
TAK-438 20 mg Once Daily	194.6	± 53.749
TAK-438 20 mg Twice Daily	222.6	± 49.670

M-IV-Sul

Group	Value	95% CI
TAK-438 10 mg Once Daily	117.1	± 37.489
TAK-438 20 mg Once Daily	256.1	± 62.786
TAK-438 20 mg Twice Daily	225.7	± 52.675

Aet: Total Amount of Drug Excreted in Urine From Time 0 to Time T for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 Primary · Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose

TAK-438F

Group	Value	95% CI
TAK-438 10 mg Once Daily	448.5	± 159.06
TAK-438 20 mg Once Daily	890.3	± 243.24
TAK-438 20 mg Twice Daily	1478	± 405.32

M-I

Group	Value	95% CI
TAK-438 10 mg Once Daily	176.6	± 79.813
TAK-438 20 mg Once Daily	253.1	± 118.69
TAK-438 20 mg Twice Daily	211.2	± 124.21

M-II

Group	Value	95% CI
TAK-438 10 mg Once Daily	0.000	± 0.0000
TAK-438 20 mg Once Daily	0.000	± 0.0000
TAK-438 20 mg Twice Daily	0.000	± 0.0000

M-III

Group	Value	95% CI
TAK-438 10 mg Once Daily	0.000	± 0.0000
TAK-438 20 mg Once Daily	0.000	± 0.0000
TAK-438 20 mg Twice Daily	0.5120	± 1.6191

M-IV-Sul

Group	Value	95% CI
TAK-438 10 mg Once Daily	205.4	± 61.587
TAK-438 20 mg Once Daily	422.1	± 143.24
TAK-438 20 mg Twice Daily	387.1	± 142.06

Fe,t: Fraction of Drug Excreted in Urine From Time 0 to Time t for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 Primary · Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose

TAK-438F

Group	Value	95% CI
TAK-438 10 mg Once Daily	4.485	± 1.5906
TAK-438 20 mg Once Daily	4.448	± 1.2093
TAK-438 20 mg Twice Daily	7.399	± 2.0335

M-I

Group	Value	95% CI
TAK-438 10 mg Once Daily	1.760	± 0.79678
TAK-438 20 mg Once Daily	1.262	± 0.59122
TAK-438 20 mg Twice Daily	1.053	± 0.61992

M-II

Group	Value	95% CI
TAK-438 10 mg Once Daily	0.000	± 0.0000
TAK-438 20 mg Once Daily	0.000	± 0.0000
TAK-438 20 mg Twice Daily	0.000	± 0.0000

M-III

Group	Value	95% CI
TAK-438 10 mg Once Daily	0.000	± 0.0000
TAK-438 20 mg Once Daily	0.000	± 0.0000
TAK-438 20 mg Twice Daily	0.002460	± 0.0077792

M-IV-Sul

Group	Value	95% CI
TAK-438 10 mg Once Daily	1.609	± 0.48258
TAK-438 20 mg Once Daily	1.650	± 0.56108
TAK-438 20 mg Twice Daily	1.513	± 0.55536

CLr: Renal Clearance for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 1 Primary · Day 1 pre-dose and at multiple timepoints (up to 48 hours) post-dose

TAK-438F

Group	Value	95% CI
TAK-438 10 mg Once Daily	5.443	± 1.0398
TAK-438 20 mg Once Daily	4.922	± 1.4362
TAK-438 20 mg Twice Daily	6.733	± 1.3109

M-I

Group	Value	95% CI
TAK-438 10 mg Once Daily	0.6235	± 0.16437
TAK-438 20 mg Once Daily	0.4465	± 0.24193
TAK-438 20 mg Twice Daily	0.3753	± 0.19679

M-II

Group	Value	95% CI
TAK-438 10 mg Once Daily	0.000	± 0.0000
TAK-438 20 mg Once Daily	0.000	± 0.0000
TAK-438 20 mg Twice Daily	0.000	± 0.0000

M-III

Group	Value	95% CI
TAK-438 10 mg Once Daily	0.000	± 0.0000
TAK-438 20 mg Once Daily	0.000	± 0.0000
TAK-438 20 mg Twice Daily	0.001820	± 0.0057553

M-IV-Sul

Group	Value	95% CI
TAK-438 10 mg Once Daily	1.748	± 0.65948
TAK-438 20 mg Once Daily	1.527	± 0.77444
TAK-438 20 mg Twice Daily	1.707	± 0.47416

Aeτ: Amount of Drug Excreted in Urine During a Dosing Interval for TAK-438F and Its Metabolites M-I, M-II, M-III and M-IV-Sul on Day 9 Primary · Day 9 pre-dose and at multiple timepoints (up to 24 hours for TAK-483 10 mg once daily and 20 mg once daily; up to 12 hours for TAK-438 20 mg twice daily) post-dose

TAK-438F

Group	Value	95% CI
TAK-438 10 mg Once Daily	437.7	± 121.93
TAK-438 20 mg Once Daily	859.9	± 155.66
TAK-438 20 mg Twice Daily	1327	± 274.04

M-I

Group	Value	95% CI
TAK-438 10 mg Once Daily	224.3	± 79.531
TAK-438 20 mg Once Daily	354.1	± 165.88
TAK-438 20 mg Twice Daily	340.9	± 181.71

M-II

Group	Value	95% CI
TAK-438 10 mg Once Daily	0.000	± 0.0000
TAK-438 20 mg Once Daily	0.000	± 0.0000
TAK-438 20 mg Twice Daily	0.000	± 0.0000

M-III

Group	Value	95% CI
TAK-438 10 mg Once Daily	0.000	± 0.0000
TAK-438 20 mg Once Daily	0.000	± 0.0000
TAK-438 20 mg Twice Daily	0.000	± 0.0000

M-IV-Sul

Group	Value	95% CI
TAK-438 10 mg Once Daily	205.2	± 52.172
TAK-438 20 mg Once Daily	390.7	± 99.477
TAK-438 20 mg Twice Daily	446.4	± 139.39

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of study drug up to follow-up (Day 1 up to Day 18). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

TAK-438 10 mg Once Daily

Serious: 0/12 (0%)

Deaths: 0/12

TAK-438 20 mg Once Daily

Serious: 0/11 (0%)

Deaths: 0/11

TAK-438 20 mg Twice Daily

Serious: 0/10 (0%)

Deaths: 0/10

Other adverse events (13 terms — click to expand)

Reaction	System	TAK-438 10 mg Once Daily	TAK-438 20 mg Once Daily	TAK-438 20 mg Twice Daily
White blood cells urine positive	Investigations	—	—	—
Red blood cells urine positive	Investigations	—	—	—
Atrioventricular block first degree	Cardiac disorders	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Neutrophil count increased	Investigations	—	—	—
White blood cell count increased	Investigations	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—
Glucose urine present	Investigations	—	—	—
Protein urine present	Investigations	—	—	—

Data from ClinicalTrials.gov NCT03085836 adverse events section.

Sponsor's own description

The purpose of this study is to determine the pharmacokinetics (PK) of TAK-438 in healthy adult Chinese participants after both single and multiple dose administration.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Fluorescent Yellow Urine Induced by Vonoprazan Fumarate: A Case Report of a Benign Phenomenon.
Sheng L, Li X. · · 2026 · PMID 41694875 · DOI 10.7759/cureus.101472

Verify or expand the search:

Other trials of TAK-438

Trials testing the same drug.

NCT03808493 — A Bioequivalence (BE) Study of TAK-438 Orally Disintegrating (OD) Tablet · Phase 1 · completed
NCT03456960 — A Study to Evaluate the Bioequivalence (BE) and the Food Effect of TAK-438ASA Tablet · Phase 1 · completed
NCT03050307 — Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Gastric Ulcer Participants With or Without Helico · Phase 3 · completed
NCT03050359 — Comparison of TAK-438 (Vonoprazan) to Lansoprazole in the Treatment of Duodenal Ulcer Participants With or Without Helic · Phase 3 · completed
NCT02892409 — TAK-438 Bismuth Drug Interaction Study · Phase 1 · completed

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Other Takeda trials

Trials by the same sponsor.

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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 NCT03085836 (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: 30 January 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/NCT03085836.

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

NCT03085836

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-438

Other recruiting trials for Healthy Participants

Other Takeda trials

Verify against primary sources