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CompletedNCT04459585Updated Jul 9, 2021Results posted

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

An Early Phase 1 interventional study of Dabigatran Etexilate Mesylate and Quizartinib in Healthy Subjects, Drug-drug Interaction and Pharmacokinetics, sponsored by Daiichi Sankyo Co., Ltd.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-09.

Sponsored by Daiichi Sankyo Co., Ltd. · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

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

Read the detailed description

This study will evaluate the potential intestinal inhibitory effect of quizartinib on the pharmacokinetics of a Pgp substrate dabigatran etexilate in healthy participants.

The hypothesis for this clinical study is that quizartinib, as a P-gp inhibitor, may increase the systemic exposure (measured by area under the concentration-time curve [AUC] and maximum concentration [Cmax]) of P-gp substrates that may be sensitive to intestinal P-gp inhibition.

02

Conditions studied

  • Healthy Subjects
  • Drug-drug Interaction
  • Pharmacokinetics
  • Quizartinib

Keywords

  • Healthy subjects
  • Drug-drug Interaction
  • Pharmacokinetics
  • Quizartinib
  • P-gp
  • Dabigatran Etexilate
03

In context

Lead sponsor

Daiichi Sankyo Co., Ltd. is the lead sponsor of 72 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male and female participants 18 to 55 years of age (inclusive), with a body mass index (BMI) of 18 kg/m\^2 to 32 kg/m\^2 (inclusive) and with a minimum body weight of 45 kg at Screening.
  • In females, documented surgical sterilization, postmenopausal status for at least 1 year (follicle stimulating hormone [FSH] > 40 million international (mIU)/mL serum at Screening), or agreement to use an approved form of contraception
  • In males, agreement to avoid sperm donation for 6 months days after the dose of quizartinib
  • Participants must agree to refrain from donation of blood from 56 days prior to Screening, plasma from 2 weeks prior to Screening, and platelets from 6 weeks prior to Screening.
  • Liver function test results must be below the upper limit of normal. Hemoglobin levels must be ≥ 11.5 g/dL for female participants and ≥ 12.5 g/dL for male participants.
  • All participants must be willing to refrain from consuming grapefruit/grapefruit juice, Seville oranges, and pomegranates/pomegranate juice 10 days before the dose of the study drug is given on Day 1 until end-of-study.

Exclusion criteria

Exclusion Criteria:

  • Any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions (including lab abnormality) that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures.
  • Laboratory results (serum chemistry, hematology, and urinalysis) outside the normal range, if considered clinically significant by the investigator. Estimated glomerular filtration rate (eGFR) \< 90 mL/min at screening.
  • Women who are pregnant or breastfeeding
  • Use of any drugs or substances known to be inhibitors or inducers of CYP3A4/5 within 28 days from the first dose or 5 half-lives, if known, of the drugs or substances, whichever is greater, prior to quizartinib administration and during the study.
  • Receipt of any prescribed or over-the-counter (OTC) systemic, herbal (including St John's wort), or topical medication within 14 days of quizartinib administration, or any expectation of requiring use of such medication while participating in the study is prohibited.
  • Presence or history of clinically severe adverse reaction to any drug
  • History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (with the exception of appendectomy, hernia repair, and/or cholecystectomy)
  • A positive drugs of abuse screen from a urine ethanol test (unless the drug is medically prescribed by a licensed health care provider) or alcohol breath test at Screening or at Check-in on Day -1 or a participant who will not agree to smoke ≤10 cigarettes or equivalent per day from Screening up to Enrollment, and is unable to be restricted to ≤5 cigarettes per day and for 6 hours post dose during their period of residence in the clinical unit
  • Concomitant use of medications known to affect the elimination of serum creatinine (e.g., trimethoprim or cimetidine) and inhibitors of renal tubular secretion (eg, probenecid) within 14 days or 5 half-lives, if known, of the drugs, whichever is greater, prior to quizartinib administration
  • History or presence of an abnormal electrocardiogram (ECG), which, in the investigator's opinion, is clinically significant and/or a QT interval corrected for heart rate using Fridericia's formula >450 milliseconds (ms) at Screening.
  • Use of drugs with a risk of QT interval prolongation or torsade de pointes within 14 days of Day -1 (or 5 drug half-lives, if 5 drug half-lives are expected to exceed 14 days)
  • Consumption of alcohol- and caffeine-containing beverages within 72 hours prior to check-in and during confinement
  • Positive serology for hepatitis B surface antigen (HBsAg) and hepatitis C virus [HCV] (healthy participants), hepatitis A virus (HAV) immunoglobulin M, or anti-human immunodeficiency virus (HIV) Type 1 and Type 2 (all subjects)
  • Current enrollment in or have not yet completed at least 30 days or 5 elimination half-lives, whichever is longer, since receiving an investigational device or product, or receipt of other investigational agents within 30 days of quizartinib
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Dabigatran + Quizartinib

    Participants who will receive a single oral dose of 150mg dabigatran etexilate on Day 1 of Period 1 and then will receive a single oral dose of 60mg quizartinib 2 hours prior to the administration of a single oral dose of 150mg dabigatran etexilate on the morning of Day 5 of Period 2.

    Drug: Dabigatran Etexilate Mesylate · Drug: Quizartinib

Interventions

  • DrugDabigatran Etexilate Mesylate

    Single oral 150 mg capsule dose

    Also known as: Pradaxa

  • DrugQuizartinib

    Single oral 60 mg dose of quizartinib administered as two 30 mg tablets (26.5 mg free base per tablet)

06

What researchers measure

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib

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

    Time frame: 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)

  2. 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

    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.

    Time frame: 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)

  3. 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

    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.

    Time frame: 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)

Secondary outcomes

  1. Time of Maximum Plasma Concentration (Tmax) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib

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

    Time frame: 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)

  2. Terminal Elimination Half-Life (T1/2) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib

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

    Time frame: 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)

  3. Maximum Plasma Concentration (Cmax) of Quizartinib and the Metabolite ACC886 Following Single Dose of Dabigatran With Quizartinib in Participants

    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.

    Time frame: 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)

  4. Time of Maximum Plasma Concentration (Tmax) of Quizartinib and the Metabolite ACC886 Following Single Dose of Dabigatran With Quizartinib in Participants

    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.

    Time frame: 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)

  5. 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

    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.

    Time frame: 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)

  6. Number of Participants Reporting Treatment-Emergent Adverse Events (TEAE) Relatedness to Study Medication Following Single Dose of Dabigatran Without and With Quizartinib in Participants

    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.

    Time frame: Up to 2 months

07

Results

Posted Jul 9, 2021

Participant flow

A total of 20 participants who met all inclusion criteria and no exclusion criteria were enrolled from 28 Aug 2020 to 20 Oct 2020 at 1 clinic in the United States.

Period 1 (Day 1 to Day 5)
Participant flow — Period 1 (Day 1 to Day 5)
MilestoneDabigatran Etexilate/Dabigatran Etexilate + Quizartinib
Started20
Completed20
Not completed0
Period 2 (Day 5 to Day 12)
Participant flow — Period 2 (Day 5 to Day 12)
MilestoneDabigatran Etexilate/Dabigatran Etexilate + Quizartinib
Started20
Completed20
Not completed0

Outcome measures

PrimaryMaximum Plasma Concentration (Cmax) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib

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

Time frame:
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)
Reported as:
Mean · ng/mL
Maximum Plasma Concentration (Cmax) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib
ng/mLPeriod 1: Dabigatran EtexilatePeriod 2: Dabigatran Etexilate + Quizartinib
Total Dabigatran192 ± 94.5239 ± 141
Free Dabigatran159 ± 82.2201 ± 127
Statistical analysis
  • Period 1: Dabigatran Etexilate vs Period 2: Dabigatran Etexilate + Quizartinib · Ratio (%) of geometric ls mean: 111.88 · 90% CI 77.57 to 161.35For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.
  • Period 1: Dabigatran Etexilate vs Period 2: Dabigatran Etexilate + Quizartinib · Ratio (%) of geometric ls mean: 112.98 · 90% CI 77.20 to 165.34For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.
PrimaryArea 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

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.

Time frame:
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)
Reported as:
Mean · ng*h/mL
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
ng*h/mLPeriod 1: Dabigatran EtexilatePeriod 2: Dabigatran Etexilate + Quizartinib
Total Dabigatran1720 ± 8702100 ± 1280
Free Dabigatran1390 ± 7361710 ± 1100
Statistical analysis
  • Period 1: Dabigatran Etexilate vs Period 2: Dabigatran Etexilate + Quizartinib · Ratio (%) of geometric ls mean: 111.37 · 90% CI 78.51 to 157.97For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.
  • Period 1: Dabigatran Etexilate vs Period 2: Dabigatran Etexilate + Quizartinib · Ratio (%) of geometric ls mean: 111.08 · 90% CI 77.35 to 159.51For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.
PrimaryArea 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

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.

Time frame:
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)
Reported as:
Mean · ng*h/mL
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
ng*h/mLPeriod 1: Dabigatran EtexilatePeriod 2: Dabigatran Etexilate + Quizartinib
Total Dabigatran1740 ± 9022140 ± 1280
Free Dabigatran1420 ± 7601730 ± 1100
Statistical analysis
  • Period 1: Dabigatran Etexilate vs Period 2: Dabigatran Etexilate + Quizartinib · Ratio (%) of geometric ls mean: 112.97 · 90% CI 79.38 to 160.79For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.
  • Period 1: Dabigatran Etexilate vs Period 2: Dabigatran Etexilate + Quizartinib · Ratio (%) of geometric ls mean: 110.72 · 90% CI 76.77 to 159.68For the comparison, the Dabigatran Etexilate + Quizartinib (Period 2) represents the numerator and Dabigatran Etexilate (Period 1) represents the denominator.
SecondaryTime of Maximum Plasma Concentration (Tmax) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib

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

Time frame:
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)
Reported as:
Median · hours
Time of Maximum Plasma Concentration (Tmax) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib
hoursPeriod 1: Dabigatran EtexilatePeriod 2: Dabigatran Etexilate + Quizartinib
Total Dabigatran2.0 (1.5 to 3.1)2.0 (1.5 to 4.0)
Free Dabigatran2.0 (1.5 to 4.0)2.0 (1.5 to 4.0)
SecondaryTerminal Elimination Half-Life (T1/2) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib

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

Time frame:
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)
Reported as:
Mean · hours
Terminal Elimination Half-Life (T1/2) of Total Dabigatran and of Free Dabigatran Following a Single Dose in Participants Without and With Concomitant Quizartinib
hoursPeriod 1: Dabigatran EtexilatePeriod 2: Dabigatran Etexilate + Quizartinib
Total Dabigatran15.4 ± 4.418.1 ± 17.0
Free Dabigatran14.2 ± 4.214.1 ± 6.6
SecondaryMaximum Plasma Concentration (Cmax) of Quizartinib and the Metabolite ACC886 Following Single Dose of Dabigatran With Quizartinib in Participants

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.

Time frame:
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)
Reported as:
Median · ng/mL
Maximum Plasma Concentration (Cmax) of Quizartinib and the Metabolite ACC886 Following Single Dose of Dabigatran With Quizartinib in Participants
ng/mLPeriod 2: Dabigatran Etexilate + Quizartinib
Quizartinib250 ± 50.8
AC88625.7 ± 8.71
SecondaryTime of Maximum Plasma Concentration (Tmax) of Quizartinib and the Metabolite ACC886 Following Single Dose of Dabigatran With Quizartinib in Participants

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.

Time frame:
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)
Reported as:
Median · hours
Time of Maximum Plasma Concentration (Tmax) of Quizartinib and the Metabolite ACC886 Following Single Dose of Dabigatran With Quizartinib in Participants
hoursPeriod 2: Dabigatran Etexilate + Quizartinib
Quizartinib3.0 (2.5 to 6.0)
AC8868.0 (3.5 to 26.1)
SecondaryArea 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

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.

Time frame:
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)
Reported as:
Mean · ng*h/mL
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
ng*h/mLPeriod 2: Dabigatran Etexilate + Quizartinib
Quizartinib9390 ± 1660
AC8861350 ± 495
SecondaryNumber of Participants Reporting Treatment-Emergent Adverse Events (TEAE) Relatedness to Study Medication Following Single Dose of Dabigatran Without and With Quizartinib in Participants

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.

Time frame:
Up to 2 months
Reported as:
Count of participants · Participants
Number of Participants Reporting Treatment-Emergent Adverse Events (TEAE) Relatedness to Study Medication Following Single Dose of Dabigatran Without and With Quizartinib in Participants
ParticipantsPeriod 1: Dabigatran EtexilatePeriod 2: Dabigatran Etexilate + Quizartinib
Related02
Unrelated01

Adverse events

Collected over Adverse events were collected from the date of signing the informed consent form up to 30 days after last dose, up to 2 months.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Period 1: Dabigatran Etexilate0/20 (0%)0/20 (0%)0/20 (0%)
Period 2: Dabigatran Etexilate + Quizartinib0/20 (0%)0/20 (0%)3/20 (15%)
Most frequent other events
Most frequent other events
EventPeriod 1: Dabigatran EtexilatePeriod 2: Dabigatran Etexilate + Quizartinib
DizzinessNervous system disorders0/201/20
HeadacheNervous system disorders0/201/20
ParaesthesiaNervous system disorders0/201/20

Baseline characteristics

Baseline characteristics were assessed using the Safety Analysis Set.

Age, Categorical
Age, Categorical(Participants)Dabigatran Etexilate/Dabigatran Etexilate + Quizartinib
<=18 years0
Between 18 and 65 years20
>=65 years0
Age, Continuous
Age, Continuous(years)Dabigatran Etexilate/Dabigatran Etexilate + Quizartinib
Mean39.0 ± 10.37
Sex: Female, Male
Sex: Female, Male(Participants)Dabigatran Etexilate/Dabigatran Etexilate + Quizartinib
Female9
Male11
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Dabigatran Etexilate/Dabigatran Etexilate + Quizartinib
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American12
White8
More than one race0
Unknown or Not Reported0
08

Study locations

1 site
  • Worldwide Clinical Trials
    San Antonio, Texas 78217, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 4, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04459585
Lead sponsor
Daiichi Sankyo Co., Ltd.
Responsible party
Sponsor
First posted
Jul 7, 2020
Start date
Aug 28, 2020
Primary completion
Oct 20, 2020
Completion
Oct 20, 2020
Results posted
Jul 9, 2021
Last update
Jul 9, 2021

Study contacts

Global Clinical Leader
study director · Daiichi Sankyo

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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