cancer solid tumors
Conditions
Interventions
Part A
Treatment A: a single oral dose of 100 mg E7050 in the fasted state
Treatment B: a single oral dose of 100 mg E7050 in the fed state (low fat
breakfast)
Treatment C: a single oral dose of 100
Sponsors
Eisai
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: plasma and urine E7050 concentrations, pharmacokinetic parameters | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination | — |
Countries
Netherlands
Outcome results
None listed