Single and Multiple Dose Asian Bridging Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01251731
First received: November 30, 2010
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to evaluate the single-dose (SD) pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of 10, 40, and 80 mg E5501 followed by a selected dose for multiple dosing (MD) in healthy Japanese, Chinese, and Caucasian subjects.


Condition Intervention Phase
Healthy Subjects
Drug: E5501
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, 3-Way Crossover Study to Evaluate the Single-Dose Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of 10, 40, and 80 mg E5501 Followed by a Selected Dose for Multiple Dosing Administered to Healthy Japanese, Chinese, and Caucasian Subjects

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • • To compare the single-dose pharmacokinetics (PK), as measured by AUCinf of three doses of E5501 (10, 40, and 80 mg) in healthy Japanese and Chinese subjects relative to healthy Caucasian subjects [ Time Frame: up to 96 hours post-dose ] [ Designated as safety issue: No ]
  • • To compare the multiple-dose steady-state PK, as measured by AUCss, of E5501 in healthy Japanese and Chinese subjects relative to Caucasian subjects [ Time Frame: up to 96 hours after dosing on Day 7 or up to 240 hours after the first drug dosing ] [ Designated as safety issue: No ]
  • • To compare the multiple-dose pharmacodynamic (PD) response as measured by platelet counts for E5501 in healthy Japanese and Chinese subjects relative to Caucasian subjects [ Time Frame: through Day 21 for each SD Treatment Period and through Day 30 for the MD Treatment Period ] [ Designated as safety issue: No ]
  • • To compare the single-dose pharmacokinetics (PK), as measured by Cmax of three doses of E5501 (10, 40, and 80 mg) in healthy Japanese and Chinese subjects relative to healthy Caucasian subjects [ Time Frame: up to 96 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate single-dose linearity of 10, 40 and 80mg E5501 in healthy Japanese, Chinese, and Caucasian subjects [ Time Frame: from Day 1 SD Treatment Period 1 through Day 30 MD Treatment Period 4 ] [ Designated as safety issue: No ]
  • To characterize PK/PD relationships between E5501 exposure and platelet count response in healthy Japanese, Chinese, and Caucasian subjects [ Time Frame: from Day 1 SD Treatment Period 1through Day 30 MD Treatment Period 4 ] [ Designated as safety issue: No ]

Enrollment: 36
Study Start Date: July 2010
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Group 1 Drug: E5501
Treatment Group 1: 10mg E5501 as a single dose in Treatment Period 1, followed by a single dose of 40mg E5501 in Treatment Period 2, followed by a single dose of 80mg E5501 in Treatment Period 3, followed by a selected dose for the Multiple Dose reatment Period.
Experimental: Treatment Group 2 Drug: E5501
Treatment Group 2: 40 mg E5501 as a single dose in Treatment Period 1, followed by a single dose of 80mg E5501 in Treatment Period 2, followed by a single dose of 10mg E5501 in Treatment Period 3, followed by a selected dose for the Multiple Dose Treatment Period.
Experimental: Treatment Group 3 Drug: E5501
Treatment Group 3: 80mg E5501 as a single dose in Treatment Period 1, followed by a single dose of 10mg E5501 in Treatment Period 2, followed by a single dose of 40mg E5501 in Treatment Period 3, followed by a selected dose for the Multiple Dose Treatment Period.
Experimental: Treatment Group 4 Drug: E5501
Treatment Group 4: A single dose of matching placebo in each of the three Single Dose Treatment Periods and in the Multiple Dose Treatment Period

Detailed Description:

This study will evaluate the single-dose (SD) pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of oral doses of 10, 40, and 80 mg E5501 administered to 36 healthy male and female Japanese, Chinese, and Caucasian subjects. For the SD Treatment Period, 12 subjects from each ethnic group will be randomized to receive single doses of 10, 40, or 80 mg E5501 or matching placebo each treatment period. Each subject will be allocated to a treatment sequence to be dosed with either placebo for the three periods or dosed with each of the three different doses in the three periods. For the Multiple-Dose (MD) Treatment Period the 12 subjects in each ethnic group will be further randomized as active (dose level to be determined from the SD Treatment Period or placebo in a 3:1 ratio.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Key Inclusion Criteria:

  • Normal healthy adult males and females (age 20-45 years)
  • Body Mass Index greater than or equal to 18 and less than or equal to 29 at the time of screening
  • Japanese and Chinese subjects must be born in their respective countries of origin and have parents and grandparents of Japanese or Chinese descent, respectively
  • Japanese subjects must have lived outside of Japan for no more than 5 years; Chinese subjects must have lived outside of China for no more than 10 years
  • In addition to mainland China, Chinese subjects may be from Taiwan, Hong Kong, or Mongolia
  • Japanese and Chinese subjects must not have significantly changes their lifestyle with regard to diet; i.e., their diet must not have significantly changed since leaving China or Japan
  • Platelet count between 150,000 and 300,000/mm3

Key Exclusion Criteria:

  • Evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery that could impact the PK of the study drug
  • Evidence of organ dysfunction or any clinically significant deviation from normal in their medical history, e.g., history of splenectomy
  • History of venous or arterial thrombotic disease or other hypercoagulable state
  • Hemoglobin level less than 12.0 g/dL
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01251731

Locations
United States, California
Parexel International, Early Phase Clinical Unit
Los Angeles, California, United States
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Franklin Johnson Eisai Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01251731     History of Changes
Other Study ID Numbers: E5501-A001-006
Study First Received: November 30, 2010
Last Updated: April 4, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 20, 2014