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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

November 30, 2010
April 4, 2012
July 2010
January 2011   (final data collection date for primary outcome measure)
  • • 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 ]
Same as current
Complete list of historical versions of study NCT01251731 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Single and Multiple Dose Asian Bridging Study
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

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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Healthy Subjects
  • 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.
  • 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.
  • 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.
  • 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
  • Experimental: Treatment Group 1
    Intervention: Drug: E5501
  • Experimental: Treatment Group 2
    Intervention: Drug: E5501
  • Experimental: Treatment Group 3
    Intervention: Drug: E5501
  • Experimental: Treatment Group 4
    Intervention: Drug: E5501
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
Not Provided
January 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01251731
E5501-A001-006
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Franklin Johnson Eisai Inc.
Eisai Inc.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP