Pharmacokinetics and Food Effect of Single Oral Dose of E7050 in Healthy Volunteers

• Register: ClinicalTrials.gov
• Last refreshed on: 7 December 2015
• Main ID: NCT02533102
• Date of registration: 24/08/2015
• Prospective Registration: No
• Primary sponsor: Eisai Limited
• Public title: Pharmacokinetics and Food Effect of Single Oral Dose of E7050 in Healthy Volunteers
• Scientific title: 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
• Date of first enrolment: November 2010
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02533102
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Netherlands

Key inclusion & exclusion criteria

Inclusion criteria:

Subjects must meet all of the following criteria to be included in this study:

1. Normal healthy adult males and females (age 18-45 years).

2. Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 32 at the
time of Screening.

3. Pregnancy or lactation. Female patients of childbearing potential must have a
negative pregnancy test before inclusion into the study, and must agree to use
medically acceptable methods of contraception (eg, abstinence, condom + spermicide,
or a double-barrier method [eg, condom + diaphragm with spermicide], or intrauterine
device (IUD), or have a vasectomised partner) starting at Screening and throughout
the entire study period and for 2 months after the last dose of study drug. Those
female patients using hormonal contraceptives must also be using an additional
approved method of contraception (as described previously) starting at Cycle 1 Day 1,
and continuing throughout the entire study period and for 2 months after the last
dose of study drug. Postmenopausal women must have been amenorrheic for at least 12
consecutive months; otherwise a pregnancy test is required. Male patients must agree
to use contraceptive methods (eg, abstinence, condom + spermicide or a double-barrier
method [eg, condom + partner diaphragm with spermicide]).

4. Non-smokers.

5. Willing and able to comply with all aspects of the protocol.

6. Provide written informed consent.

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from this study:

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. An interval corrected for heart rate (QTcF) interval greater than 450 msec at
Screening or Baseline.

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 less than 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
t1/2, ie, 5 x t1/2 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.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy Subjects

Intervention(s)

Drug: E7050

Primary Outcome(s)

E7050 pharmacokinetic parameter: AUC 0-t (area under the plasma concentration-time profile from time 0 to the last measurable concentration) [Time Frame: 0 hour to 168 hours]

E7050 pharmacokinetic parameter: t1/2 (the terminal half-life) [Time Frame: 0 hour to 168 hours]

E7050 pharmacokinetic parameter: tmax (time to maximum plasma concentration) [Time Frame: 0 hour to 168 hours]

E7050 pharmacokinetic parameter: AUC 0-inf (area under the plasma concentration-time profile from time 0 to infinity) [Time Frame: 0 hour to 168 hours]

E7050 pharmacokinetic parameter: t lag (time point immediately prior to the first quantifiable concentration) [Time Frame: 0 hour to 168 hours]

E7050 pharmacokinetic parameter: Cmax (maximum observed plasma concentration) [Time Frame: 0 hour to 168 hours]

Secondary Outcome(s)

Number of participants as a measure of adverse events (AEs) and serious adverse events (SAEs) [Time Frame: Up to 9 weeks]

Secondary ID(s)

E7050-E044-004

Source(s) of Monetary Support

Please refer to primary and secondary sponsors