NCT02918266 is a Phase 1 clinical trial of Scopolamine in Healthy Volunteers, sponsored by Takeda.

Who is sponsoring NCT02918266?

NCT02918266 is sponsored by Takeda.

What drugs are being tested in NCT02918266?

Interventions in NCT02918266: Scopolamine, TAK-071, Donepezil, Scopolamine Placebo, TAK-071 Placebo, Donepezil Placebo.

What condition does NCT02918266 study?

NCT02918266 studies Healthy Volunteers.

Is NCT02918266 still recruiting?

NCT02918266 is currently terminated. Last updated 14 June 2019.

Are results published for NCT02918266?

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

Last reviewed 2019-06-14 · How we verify

NCT02918266

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

TAK-071 Scopolamine-Induced Cognitive Impairment Study

Terminated Phase 1 Results posted Last updated 14 June 2019

What this trial tests

Phase 1 trial testing Scopolamine in Healthy Volunteers in 18 participants. Terminated before completion.

Timeline

21 November 2016

Primary endpoint
2 August 2017

8 August 2017

Quick facts

Lead sponsor	Takeda
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	basic science
Enrollment	18
Start date	21 November 2016
Primary completion	2 August 2017
Estimated completion	8 August 2017
Sites	1 location across United States

Drugs / interventions tested

Scopolamine — full drug profile →
TAK-071 — full drug profile →
Donepezil (DONEPEZIL) — full drug profile →
Scopolamine Placebo
TAK-071 Placebo — full drug profile →
Donepezil Placebo — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

Takeda — full company profile →

Who can join

Adults 18 to 55, male only, 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.

Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE) Secondary · Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1

Group	Value	95% CI
Scopolamine 0.5 mg SC + TAK-071 80 mg	66.7
Part 2: Treatment A	66.7
Part 2: Treatment B	100.0
Part 2: Treatment C	100.0
Part 2: Treatment D	100.0
Part 2: Treatment E	100.0

Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Clinical Laboratory Tests at Least Once Postdose Secondary · Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1

Group	Value	95% CI
Scopolamine 0.5 mg SC + TAK-071 80 mg	0
Part 2: Treatment A	0
Part 2: Treatment B	0
Part 2: Treatment C	0
Part 2: Treatment D	0
Part 2: Treatment E	0

Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Postdose Secondary · Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1

Diastolic Blood Pressure (mmHg)/Supine <50 mmHg

Group	Value	95% CI
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg	0
Part 2: Treatment A	0
Part 2: Treatment B	0
Part 2: Treatment C	0
Part 2: Treatment D	0
Part 2: Treatment E	0

Pulse rate/supine: <50 beats per minute

Group	Value	95% CI
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg	33.3
Part 2: Treatment A	33.3
Part 2: Treatment B	50.0
Part 2: Treatment C	0
Part 2: Treatment D	0
Part 2: Treatment E	50.0

Temperature: <35.6 Celsius

Group	Value	95% CI
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg	0
Part 2: Treatment A	0
Part 2: Treatment B	0
Part 2: Treatment C	33.3
Part 2: Treatment D	0
Part 2: Treatment E	0

Temperature: >37.7 Celsius

Group	Value	95% CI
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg	16.7
Part 2: Treatment A	0
Part 2: Treatment B	0
Part 2: Treatment C	0
Part 2: Treatment D	0
Part 2: Treatment E	0

Percentage of Participants Who Meet the Takeda Markedly Abnormal Criteria for Electrocardiogram (ECG) at Least Once Postdose Secondary · Part 1: Baseline up to Day 12; Part 2: Baseline up to Day 9 of Period 1

Group	Value	95% CI
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg	16.7
Part 2: Treatment A	0
Part 2: Treatment B	50.0
Part 2: Treatment C	0
Part 2: Treatment D	0
Part 2: Treatment E	50.0

Cmax: Maximum Observed Plasma Concentration for TAK-071 Secondary · Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose

Group	Value	95% CI
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg	1066	± 16.8

Tmax: Time to Reach the Maximum Observed Plasma Concentration(Cmax) for TAK-071 Secondary · Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose

Group	Value	95% CI
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg	30.00	12.0 – 34.0

AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-071 Secondary · Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose

Group	Value	95% CI
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg	82010	± 25.0

AUC24: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Postdose for TAK-071 Secondary · Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 24 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 24 hours) post-scopolamine dose

Group	Value	95% CI
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg	19330	± 16.0

AUC∞: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity for TAK-071 Secondary · Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose

Group	Value	95% CI
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg	94100	± 26.8

T1/2z: Terminal Disposition Phase Elimination Half-Life in Plasma for TAK-071 Secondary · Part 1: Day 1 pre-TAK-071 dose and at multiple time points (up to 168 hours) post-TAK-071 dose; Part 2: Day 2 pre-TAK-071 dose and at multiple time points (up to 10 hours) post-scopolamine dose

Group	Value	95% CI
Part 1: TAK-071 80 mg + Scopolamine 0.5 mg	47.02	± 14.864

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment emergent adverse events (TEAEs) are adverse events that started after the first dose of study drug up to Day 12 in Part 1 and Day 9 of Period 1 in Part 2 (study termination) after the last dose of study drug. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1: TAK-071 80 mg + Scopolamine 0.5 mg

Serious: 0/6 (0%)

Deaths: 0/6

Part 2: Treatment A

Serious: 0/3 (0%)

Deaths: 0/3

Part 2: Treatment B

Serious: 0/2 (0%)

Deaths: 0/2

Part 2: Treatment C

Serious: 0/3 (0%)

Deaths: 0/3

Part 2: Treatment D

Serious: 0/2 (0%)

Deaths: 0/2

Part 2: Treatment E

Serious: 0/2 (0%)

Deaths: 0/2

Other adverse events (10 terms — click to expand)

Reaction	System	Part 1: TAK-071 80 mg + Sc…	Part 2: Treatment A	Part 2: Treatment B	Part 2: Treatment C	Part 2: Treatment D	Part 2: Treatment E
Somnolence	Nervous system disorders	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Odynophagia	Gastrointestinal disorders	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT02918266 adverse events section.

Sponsor's own description

The purpose of this study is to assess the effect of a single oral dose of TAK-071 on the attenuation of cognitive deficit induced by scopolamine as measured by Groton Maze Learning Test (GMLT) (total number of errors).

Publications & conference data

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

Recent advances in targeting the "undruggable" proteins: from drug discovery to clinical trials.
Xie X, Yu T, Li X, Zhang N, et al · · 2023 · cited 246× · PMID 37669923 · DOI 10.1038/s41392-023-01589-z
Drug Design Targeting the Muscarinic Receptors and the Implications in Central Nervous System Disorders.
Johnson CR, Kangas BD, Jutkiewicz EM, Bergman J, et al · · 2022 · cited 34× · PMID 35203607 · DOI 10.3390/biomedicines10020398

Verify or expand the search:

Other trials of Scopolamine

Trials testing the same drug.

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NCT03131050 — Effectiveness Study of Scopolamine Combined With Escitalopram in Patients With MDD · Phase 4 · 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 NCT02918266 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 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: 14 June 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/NCT02918266.

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

NCT02918266

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 Scopolamine

Other recruiting trials for Healthy Volunteers

Other Takeda trials

Verify against primary sources