A Study to Evaluate the Relative Bioavailability and Intra-Subject Variability of Two Lots of E5501 40 mg Tablets Administered Twice as Single Oral Doses to Healthy Subjects

Idiopathic Thrombocytopenia Purpura Clinical Trial

Official title:

A Randomized, Open-Label, 4-Way Crossover Replicate Design Study to Evaluate the Relative Bioavailability and Intra-Subject Variability of Two Lots of E5501 40 mg Tablets Administered Twice as Single Oral Doses to Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01289509
• Other study ID #: E5501-A001-007
• Status: Completed
• Phase: Phase 1
• First received: January 27, 2011
• Last updated: October 31, 2013
• Start date: December 2010
• Est. completion date: May 2011

Study information

• Verified date: October 2013
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the relative bioavailability (BA) of two lots of E5501 40 mg tablets administered twice as single oral doses to healthy subjects.

Description:

This is a randomized, open label, 4- way crossover, replicate design study to evaluate the bioavailability (BA) of E5501 new Phase 3 formulation Lot P97001ZZB 40 mg tablet manufactured July, 2009 (Treatment A ,reference drug) relative to Lot P01010ZZA 40 mg tablet manufactured January, 2010 (Treatment B, test drug) administered to 42 healthy male and female subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Normal healthy adult male or female subjects age greater than or equal to 18 years and less than or equal to 55 years old.

• Body mass index greater than or equal to 18 kg/m2 and less than or equal to 32 kg/m2 at the time of screening.

• Platelet count between 120x109/L and 250x109/L.

• Women of childbearing potential must agree to use a double barrier method of contraception during the Randomization Phase of the study.

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 pharmacokinetics (PK)of the study drug.

• Agents associated with thrombotic events (including oral contraceptives) must be discontinued within 30 days of the first study drug administration.

• 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 hypercoaguable state.

• Hemoglobin level less than 11.5 g/dL for females and 13.5g /dL for males

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Idiopathic Thrombocytopenia Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia
• Thrombocytosis

Intervention

Drug:
• E5501
Lot P01010ZZA (test) single oral doses of 40 mg tablets.
• Drug: E5501
Lot P97001ZZB (reference) single oral doses of 40 mg tablets.

Locations

Country	Name	City	State
United States	PRA	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• To evaluate the bioavailability (BA) , as measured by AUC point estimates of E5501 40 mg tablet Lot P01010ZZA (test) relative to E5501 40 mg tablet Lot P97001ZZB (reference).		96 hours post-dose	No
Primary	To evaluate the bioavailability, as measured by Cmax point estimates of E5501 40 mg tablet Lot P01010ZZA (test) relative to E5501 40 mg tablet Lot P97001ZZB (reference).		96 hours post dose	No
Secondary	• To assess the intra-subject and inter-subject variability in Cmax following replicate dosing with E5501 40 mg lots		10 weeks	No
Secondary	• To assess the intra-subject and inter-subject variability in AUC(0-inf) following replicate dosing with E5501 40 mg lots.		10 weeks	No