Clinical trial NCT01289509: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Idiopathic Thrombocytopenia Purpura
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-03
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: • 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).
timeFrame: 96 hours post-dose
measure: 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).
timeFrame: 96 hours post dose
Secondary outcomes:
measure: • To assess the intra-subject and inter-subject variability in Cmax following replicate dosing with E5501 40 mg lots
timeFrame: 10 weeks
measure: • To assess the intra-subject and inter-subject variability in AUC(0-inf) following replicate dosing with E5501 40 mg lots.
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA
state: Kansas
Study officials:
affiliation: Eisai Inc.
name: Franklin Johnson
role: STUDY_DIRECTOR
References: