Single and Multiple Dose Asian Bridging Study

NCT01251731 | Completed Phase 1

• 1 other identifier: E5501-A001-006
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (4)

• • 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

  up to 96 hours post-dose

• • To compare the multiple-dose steady-state PK, as measured by AUCss, of E5501 in healthy Japanese and Chinese subjects relative to Caucasian subjects

  up to 96 hours after dosing on Day 7 or up to 240 hours after the first drug dosing

• • 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

  through Day 21 for each SD Treatment Period and through Day 30 for the MD Treatment Period

• • 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

  up to 96 hours post-dose

Secondary Outcomes (2)

• To evaluate single-dose linearity of 10, 40 and 80mg E5501 in healthy Japanese, Chinese, and Caucasian subjects

  from Day 1 SD Treatment Period 1 through Day 30 MD Treatment Period 4

• To characterize PK/PD relationships between E5501 exposure and platelet count response in healthy Japanese, Chinese, and Caucasian subjects

  from Day 1 SD Treatment Period 1through Day 30 MD Treatment Period 4

Study Arms (4)

Treatment Group 1

EXPERIMENTAL

Drug: E5501

Treatment Group 2

EXPERIMENTAL

Drug: E5501

Treatment Group 3

EXPERIMENTAL

Drug: E5501

Treatment Group 4

EXPERIMENTAL

Drug: E5501

Interventions

E5501 DRUG

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.

Treatment Group 1

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Parexel International, Early Phase Clinical Unit

Los Angeles, California, United States

Location

MeSH Terms

Interventions

avatrombopag

Study Officials

• Franklin Johnson

  Eisai Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2010
• First Posted: December 2, 2010
• Study Start: July 1, 2010
• Primary Completion: January 1, 2011
• Last Updated: April 6, 2012

Record last verified: 2012-04

Locations

US (1)