NCT04459585 is a EARLY_PHASE1 clinical trial of Dabigatran Etexilate Mesylate in Healthy Subjects, sponsored by Daiichi Sankyo Co., Ltd..

Who is sponsoring NCT04459585?

NCT04459585 is sponsored by Daiichi Sankyo Co., Ltd..

What drugs are being tested in NCT04459585?

Interventions in NCT04459585: Dabigatran Etexilate Mesylate, Quizartinib.

What condition does NCT04459585 study?

NCT04459585 studies Healthy Subjects, Drug-drug Interaction, Pharmacokinetics, Quizartinib.

Is NCT04459585 still recruiting?

NCT04459585 is currently completed. Last updated 9 July 2021.

Are results published for NCT04459585?

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

Last reviewed 2021-07-09 · How we verify

NCT04459585

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

A Study of the Effect of Quizartinib on the Pharmacokinetics of the P-gp Substrate Dabigatran Etexilate in Healthy Participants

Completed EARLY_PHASE1 Results posted Last updated 9 July 2021

What this trial tests

EARLY_PHASE1 trial testing Dabigatran Etexilate Mesylate in Healthy Subjects in 20 participants. Completed in 20 October 2020.

Timeline

28 August 2020

Primary endpoint
20 October 2020

20 October 2020

Quick facts

Lead sponsor	Daiichi Sankyo Co., Ltd.
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	28 August 2020
Primary completion	20 October 2020
Estimated completion	20 October 2020
Sites	1 location across United States

Drugs / interventions tested

Dabigatran Etexilate Mesylate — full drug profile →
Quizartinib (QUIZARTINIB) — full drug profile →

Conditions studied

Healthy Subjects — all drugs for Healthy Subjects →
Drug-drug Interaction — all drugs for Drug-drug Interaction →
Pharmacokinetics — all drugs for Pharmacokinetics →
Quizartinib — all drugs for Quizartinib →

Sponsor

Daiichi Sankyo Co., Ltd. — full company profile →

Who can join

Adults 18 to 55, any sex, with Healthy Subjects or Drug-drug Interaction. 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.

Maximum Plasma Concentration (Cmax) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib Primary · Period 1 Day 1 (Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60 and 72 hours post-dose) and Period 2 Day 5 (pre-dose and 1, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14, 26, 38, 50, 62, and 74 hours post-dose)

Maximum Plasma Concentration (Cmax) is defined as the maximum observed plasma concentration and was calculated using non-compartmental analysis.

Total Dabigatran

Group	Value	95% CI
Period 1: Dabigatran Etexilate	192	± 94.5
Period 2: Dabigatran Etexilate + Quizartinib	239	± 141

Free Dabigatran

Group	Value	95% CI
Period 1: Dabigatran Etexilate	159	± 82.2
Period 2: Dabigatran Etexilate + Quizartinib	201	± 127

Area Under the Plasma Concentration-Time Curve up to the Last Quantifiable Concentration Post-Dose (AUClast) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib Primary · Period 1 Day 1 (Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60 and 72 hours post-dose) and Period 2 Day 5 (pre-dose and 1, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14, 26, 38, 50, 62, and 74 hours post-dose)

Area Under the Plasma Concentration-Time Curve up to the Last Quantifiable Concentration Post-Dose (AUClast) is defined as AUC from time 0 to the last measurable concentration, as calculated by the linear up-log down trapezoidal method and was calculated using non-compartmental analysis.

Total Dabigatran

Group	Value	95% CI
Period 1: Dabigatran Etexilate	1720	± 870
Period 2: Dabigatran Etexilate + Quizartinib	2100	± 1280

Free Dabigatran

Group	Value	95% CI
Period 1: Dabigatran Etexilate	1390	± 736
Period 2: Dabigatran Etexilate + Quizartinib	1710	± 1100

Area Under the Plasma Concentration-Time Curve up to Infinity (AUCinf) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib Primary · Period 1 Day 1 (Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60 and 72 hours post-dose) and Period 2 Day 5 (pre-dose and 1, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14, 26, 38, 50, 62, and 74 hours post-dose)

Area Under the Plasma Concentration-Time Curve up to Infinity (AUCinf) is defined as area under the plasma concentration-time curve from the time of dosing extrapolated to infinity and was calculated using non-compartmental analysis.

Total Dabigatran

Group	Value	95% CI
Period 1: Dabigatran Etexilate	1740	± 902
Period 2: Dabigatran Etexilate + Quizartinib	2140	± 1280

Free Dabigatran

Group	Value	95% CI
Period 1: Dabigatran Etexilate	1420	± 760
Period 2: Dabigatran Etexilate + Quizartinib	1730	± 1100

Time of Maximum Plasma Concentration (Tmax) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib Secondary · Period 1 Day 1 (Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60 and 72 hours post-dose) and Period 2 Day 5 (pre-dose and 1, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14, 26, 38, 50, 62, and 74 hours post-dose)

Time of Maximum Plasma Concentration (Tmax) is defined as time of maximum observed plasma concentration and was calculated using non-compartmental analysis.

Total Dabigatran

Group	Value	95% CI
Period 1: Dabigatran Etexilate	2.0	1.5 – 3.1
Period 2: Dabigatran Etexilate + Quizartinib	2.0	1.5 – 4.0

Free Dabigatran

Group	Value	95% CI
Period 1: Dabigatran Etexilate	2.0	1.5 – 4.0
Period 2: Dabigatran Etexilate + Quizartinib	2.0	1.5 – 4.0

Terminal Elimination Half-Life (T1/2) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib Secondary · Period 1 Day 1 (Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60 and 72 hours post-dose) and Period 2 Day 5 (pre-dose and 1, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14, 26, 38, 50, 62, and 74 hours post-dose)

Terminal Elimination Half-Life (T1/2) is defined as terminal elimination half-life and was calculated using non-compartmental analysis.

Total Dabigatran

Group	Value	95% CI
Period 1: Dabigatran Etexilate	15.4	± 4.4
Period 2: Dabigatran Etexilate + Quizartinib	18.1	± 17.0

Free Dabigatran

Group	Value	95% CI
Period 1: Dabigatran Etexilate	14.2	± 4.2
Period 2: Dabigatran Etexilate + Quizartinib	14.1	± 6.6

Maximum Plasma Concentration (Cmax) of Quizartinib and the Metabolite ACC886 Following Single Dose of Dabigatran With Quizartinib in Participants Secondary · Period 2 Day 5 (Pre-dose and 1, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14, 26, 38, 50, 62, and 74 hours post-dose)

Maximum Plasma Concentration (Cmax) is defined as the maximum observed plasma concentration and was calculated using non-compartmental analysis. Cmax was assessed for Quizartinib and Metabolite AC886.

Quizartinib

Group	Value	95% CI
Period 2: Dabigatran Etexilate + Quizartinib	250	± 50.8

AC886

Group	Value	95% CI
Period 2: Dabigatran Etexilate + Quizartinib	25.7	± 8.71

Time of Maximum Plasma Concentration (Tmax) of Quizartinib and the Metabolite ACC886 Following Single Dose of Dabigatran With Quizartinib in Participants Secondary · Period 2 Day 5 (Pre-dose and 1, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14, 26, 38, 50, 62, and 74 hours post-dose)

Time of Maximum Plasma Concentration (Tmax) is defined as time of maximum observed plasma concentration and was calculated using non-compartmental analysis. Tmax was assessed for Quizartinib and Metabolite AC886.

Quizartinib

Group	Value	95% CI
Period 2: Dabigatran Etexilate + Quizartinib	3.0	2.5 – 6.0

AC886

Group	Value	95% CI
Period 2: Dabigatran Etexilate + Quizartinib	8.0	3.5 – 26.1

Area Under the Plasma Concentration-Time Curve From Time 0 to 74 Hours (AUClast,74) of Quizartinib and the Metabolite ACC886 Following Single Dose of Dabigatran With Quizartinib in Participants Secondary · Period 2 Day 5 (Pre-dose and 1, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 14, 26, 38, 50, 62, and 74 hours post-dose)

Area Under the Plasma Concentration-Time Curve From Time 0 to 74 Hours (AUClast,74) is defined as area under the plasma concentration-time curve to the last quantifiable concentration post dose at 74 hours and was calculated using non-compartmental analysis. AUClast,74 was assessed for Quizartinib and Metabolite AC886.

Quizartinib

Group	Value	95% CI
Period 2: Dabigatran Etexilate + Quizartinib	9390	± 1660

AC886

Group	Value	95% CI
Period 2: Dabigatran Etexilate + Quizartinib	1350	± 495

Number of Participants Reporting Treatment-Emergent Adverse Events (TEAE) Relatedness to Study Medication Following Single Dose of Dabigatran Without and With Quizartinib in Participants Secondary · Up to 2 months

A Treatment-Emergent Adverse Events (TEAE) is defined as any event not present prior to the initiation of the drug treatment of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment. Number of any TEAE that is related and unrelated to study medication is presented.

Group	Value	95% CI
Period 1: Dabigatran Etexilate	0
Period 2: Dabigatran Etexilate + Quizartinib	2

Unrelated

Group	Value	95% CI
Period 1: Dabigatran Etexilate	0
Period 2: Dabigatran Etexilate + Quizartinib	1

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected from the date of signing the informed consent form up to 30 days after last dose, up to 2 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Period 1: Dabigatran Etexilate

Serious: 0/20 (0%)

Deaths: 0/20

Period 2: Dabigatran Etexilate + Quizartinib

Serious: 0/20 (0%)

Deaths: 0/20

Other adverse events (3 terms — click to expand)

Reaction	System	Period 1: Dabigatran Etexi…	Period 2: Dabigatran Etexi…
Dizziness	Nervous system disorders	—	—
Headache	Nervous system disorders	—	—
Paraesthesia	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT04459585 adverse events section.

Sponsor's own description

The purpose of this study is to investigate the one-way drug-drug interaction potential of quizartinib on dabigatran etexilate in healthy adult participants.

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:

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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 NCT04459585 (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 Daiichi Sankyo Co., Ltd.
Last refreshed: 9 July 2021

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/NCT04459585.

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

NCT04459585

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 Dabigatran Etexilate Mesylate

Other recruiting trials for Healthy Subjects

Other Daiichi Sankyo Co., Ltd. trials

Verify against primary sources