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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02533102
Recruitment Status : Completed
First Posted : August 26, 2015
Last Update Posted : November 20, 2015
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )

Brief Summary:
This study is designed to first evaluate the effect of food on E7050's pharmacokinetic parameters following the administration of single 100 mg oral doses of E7050 tablet to each normal healthy participant in the study (Part A), and second to characterize E7050 pharmacokinetics after single doses at 200 mg and 400 mg under fasted conditions (Part B). Part A will be a randomized, single-dose, open-label, three-treatment period crossover study. Part B is a nonrandomized, open-label, two-treatment sequential study design. Twelve participants in Treatment Period 1 will receive a single dose of 200 mg of E7050 under fasted conditions. Following review of safety data of the 200 mg dose level, an additional 12 subjects will then receive a single dose of 400 mg of E7050 in Treatment Period 2.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: E7050 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : February 2011

Arm Intervention/treatment
Experimental: Part A: E7050 100 mg tablet under fasted conditions
Participants will receive a single tablet containing 100 mg E7050 following an overnight fast.
Drug: E7050
100 mg tablet administered orally

Experimental: Part A: E7050 100 mg tablet with low-fat breakfast
Participants will receive a single tablet containing 100 mg E7050 with a standard low-fat meal.
Drug: E7050
100 mg tablet administered orally

Experimental: Part A: E7050 100 mg tablet with high-fat breakfast
Participants will receive a single tablet containing 100 mg E7050 with a standard high-fat meal.
Drug: E7050
100 mg tablet administered orally

Experimental: Part B: E7050 200 mg tablet under fasted conditions
Participants will receive a single dose of 200 mg (two 100 mg tablets) of E7050 under fasted conditions.
Drug: E7050
100 mg tablet administered orally

Experimental: Part B: E7050 400 mg tablet under fasted conditions
Participants will receive a single dose of 400 mg (four 100 mg tablets) of E7050 under fasted conditions.
Drug: E7050
100 mg tablet administered orally




Primary Outcome Measures :
  1. E7050 pharmacokinetic parameter: tmax (time to maximum plasma concentration) [ Time Frame: 0 hour to 168 hours ]
  2. E7050 pharmacokinetic parameter: Cmax (maximum observed plasma concentration) [ Time Frame: 0 hour to 168 hours ]
  3. E7050 pharmacokinetic parameter: t lag (time point immediately prior to the first quantifiable concentration) [ Time Frame: 0 hour to 168 hours ]
  4. 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 ]
  5. 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 ]
  6. E7050 pharmacokinetic parameter: t1/2 (the terminal half-life) [ Time Frame: 0 hour to 168 hours ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533102


Locations
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Netherlands
Zuidlarne, Netherlands
Sponsors and Collaborators
Eisai Limited
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Responsible Party: Eisai Limited
ClinicalTrials.gov Identifier: NCT02533102    
Other Study ID Numbers: E7050-E044-004
First Posted: August 26, 2015    Key Record Dates
Last Update Posted: November 20, 2015
Last Verified: November 2015
Keywords provided by Eisai Inc. ( Eisai Limited ):
Pharmacokinetics
E7050
Healthy Subjects