Status:
COMPLETED
A Study to Determine the Absolute Oral Bioavailability of Quizartinib Using a Radiolabeled Microtracer in Healthy Subjects
Lead Sponsor:
Daiichi Sankyo
Collaborating Sponsors:
Quotient Sciences
Conditions:
Healthy Subjects
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
Quizartinib, a selective FLT3 inhibitor, is being developed as a treatment for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The absolute oral bioavailability of quizartinib has not...
Detailed Description
Quizartinib bioavailability based on the dose-adjusted exposure of quizartinib following oral and IV administration will be assessed in healthy male subjects. The primary objective of this study is to...
Eligibility Criteria
Inclusion
- Healthy males aged 18 years to 55 years of age (inclusive) at the time of signing informed consent
- Body mass index (BMI) of 18.0 kg/m\^2 to 32.0 kg/m\^2 (inclusive) at screening
Exclusion
- History or presence of:
- Clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal (GI), endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease, as judged by the Investigator.
- Any other condition, including laboratory abnormality, that in the opinion of the Investigator, would jeopardize the safety of the subject, obtaining informed consent, compliance to the study procedures, or the validity of the study results.
- History of a clinically significant illness, in the opinion of the Investigator, within 4 weeks prior to administration of quizartinib.
- History, or presence in the average of triplicate ECGs at screening and admission (Day -1), of any of the following cardiac conduction abnormalities:
- QT interval corrected with Fridericia's formula (QTcF) \> 450 milliseconds (ms).
- Evidence of second- or third-degree atrioventricular block.
- Evidence of complete left or right bundle branch block.
- QRS or T wave morphology that could, in the Investigator's opinion, render QT interval assessment unreliable (confirmed with triplicate ECG).
- Laboratory results (serum chemistry, hematology, coagulation, and urinalysis) outside the normal range, if considered clinically significant by the Investigator at screening or admission (Day -1).
- Estimated creatinine clearance (CrCl) \<90 mL/min (calculated using Cockcroft-Gault Equation) at screening.
- Use of drugs with a risk of QT interval prolongation or Torsades de Pointes (TdP) within 14 days of admission (Day -1) (or 5 drug half-lives, if 5 drug half-lives are expected to exceed 14 days).
Key Trial Info
Start Date :
April 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 11 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04796831
Start Date
April 26 2021
End Date
June 11 2021
Last Update
January 11 2023
Active Locations (1)
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1
Quotient Sciences
Nottingham, United Kingdom, NG11 6JS