A Single-Center, Open-Label, Randomized, 3-Treatment Crossover Bioavailability Study of Single Oral Doses of E5501 Old Tablet Formulation Under Fasted Conditions and a New Tablet Formulation Under Fed and Fasted Conditions in Healthy Subjects

NCT01260155 | Completed Phase 1

• 1 other identifier: E5501-A001-005
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be a single-center, open-label, randomized, 3-treatment crossover bioavailability study of single oral doses of E5501 old tablet formulation under fasted conditions and a new tablet formulation administered under fed and fasted conditions in healthy subjects.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• To determine the bioavailability (BA) of E5501 in one 40 mg new tablet formulation relative to two 20 mg old tablet formulation.

  2 months

Secondary Outcomes (2)

• To determine the effect of a high fat meal on the BA of E5501 in one 40 mg new tablet formulation

  2 months

• To evaluate the safety of E5501 in healthy subjects.

  2 months

Study Arms (3)

Treatment A Fasted

EXPERIMENTAL

Drug: E5501

Treatment B Fasted

EXPERIMENTAL

Drug: E5501

Treatment C Food Effect

EXPERIMENTAL

Drug: E5501

Interventions

E5501 DRUG

Treatment A: 40 mg new tablet formulation (1 tablet) under fasted conditions

Treatment A Fasted

Eligibility Criteria

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

You may qualify if:

• Normal healthy adult males and females (age 18-45 years)
• Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 32 at the time of Screening
• All females must have a negative serum human beta-chorionic gonadotropin test result or negative urine pregnancy test result at Screening and Baseline. Females of child-bearing potential must use a medically acceptable method of contraception throughout the entire study period and for 30 days after study drug discontinuation. Postmenopausal women and women who have been surgically sterilized or are proven sterile are exempt from this requirement. All women who are of reproductive potential and who are using hormonal contraceptives must have been on a stable dose of the same hormonal contraceptive product for at least 4 weeks prior to dosing and must continue to use the same contraceptive during the study and for 30 days after study drug discontinuation.
• Male subjects who are not abstinent or have not undergone a successful vasectomy, who are partners of women of child-bearing potential must use, or their partners must use, a highly effective,method of contraception starting for at least one menstrual cycle prior to starting study drug(s) and throughout the entire study period and for 30 days after the last dose of study drug.
• Willing and able to comply with all aspects of the protocol
• Provide written informed consent

You may not qualify if:

• Standard selection criteria typically used in all protocols
• Clinically significant abnormal laboratory test results, including platelet count and electrolyte abnormalities at Screening and at each Baseline

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Celerion

Phoenix, Arizona, 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: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 15, 2010
• Study Start: January 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

US (1)