Evaluation of E7050 Pharmacokinetics after 100 mg Single Oral Doses Under Fed and Fasted Conditions and Characterization of E7050 Pharmacokinetics after 100 mg, 200 mg and 400 mg Single Oral Doses Under Fasted Condition in Healthy Subjects

Completed

• Conditions: cancer; solid tumors; 10027655

• Registration Number: NL-OMON34518
• Lead Sponsor: Eisai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 42

Inclusion Criteria

* between 18 and 45 years of age
* BMI between 18 and 32 kg/m2
* non-smoker
* at screening state of health must satisfy the entry requirements

Exclusion Criteria

1. Evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematological, neurological, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery that could impact the pharmacokinetics of study drug.
2. Clinically significant illness within 8 weeks or a clinically significant infection within 4 weeks of dosing.
3. Evidence of organ dysfunction or any clinically significant deviation from normal in their medical history.
4. Evidence of clinically significant deviation from normal in physical examination, vital signs, or clinical laboratory determinations at Screening or Baseline.
5. A QTcF interval > 450 msec at Screening or Baseline, or 30 seconds before administration of study drug.
6. Females who are either pregnant or lactating.
7. A known or suspected history of drug or alcohol abuse within 6 months prior to screening, or who have a positive urine drug test or alcohol test at Screening or Baseline.
8. Positive results for Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV) screen.
9. Diagnosis of acquired immune deficiency syndrome (AIDS), or positive test for human immunodeficiency virus (HIV).
10. Participation in another clinical trial less than 4 weeks prior to dosing or current enrollment in another clinical trial.
11. Receipt of blood products within 4 weeks, or donation of blood within 8 weeks, or donation of plasma within 1 week prior to dosing.
12. Hemoglobin level < 12.0 g/dL.
13. Known history of any significant drug or food allergy or an ongoing seasonal allergy.
14. Use of prescription drugs within 2 weeks prior to Screening (unless drug has a long t*, i.e., 5x t* exceeds 2 weeks).
15. Use of over-the-counter (OTC) medications within a minimum of 2 weeks prior to dosing.
16. Requiring a special diet or taking dietary aids known to modulate drug metabolizing enzymes, or who have consumed foods/beverages or herbal preparations containing Kava root, Ginkgo Biloba Extract (GBE), or St John*s Wort within 4 weeks of Baseline Period 1.
17. Known intolerance to the study drug (or any of the excipients).
18. Any medical or other condition which, in the opinion of the investigator, would preclude participation in a clinical trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetics:<br /><br>plasma and urine E7050 concentrations, pharmacokinetic parameters</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Safety:<br /><br>adverse events, vital signs, ECG-parameters, laboratory parameters, physical<br /><br>examination</p><br>