Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01327872
• Date of registration: 30/03/2011
• Prospective Registration: No
• Primary sponsor: Eisai Inc.
• Public title: Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy Subjects
• Scientific title: A Randomized, Open-Label, 4-Group, 2-Period Replicate Design Study to Evaluate Within- and Between-Subject Variability in Exposure of Two Lots of E5501 20 mg Tablets, Administered as Single Doses of 40 mg, in the Fasted and Fed Conditions to Healthy Subjects
• Date of first enrolment: February 2011
• Target sample size: 84
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01327872
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Netherlands

Contacts

• Name: Franklin Johnson
• Affiliation: Eisai Inc.

Key inclusion & exclusion criteria

Inclusion criteria:

- Normal healthy male or female subjects age greater than or equal to 18 years and less
than or equal to 55 years

- Body mass index greater than or equal to 18 and less than or equal to 32kg/m2 at
Screening

- Platelet count greater than or equal to 120x109/L and less than or equal to 250x109/L

- Women of childbearing potential must agree to use a highly effective method of
contraception, other than estrogen-based hormonal contraceptives, 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 PK
of the study drug

- Agents associated with thrombotic events (including oral contraceptives) must be
discontinued within 30 days of 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 less than lower limit of normal (LLN) levels (females 7.1 mmol/L, males
8.1 mmol/L



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Thrombocytopenia

Purpura, Thrombocytopenic, Idiopathic

Acute Idiopathic Thrombocytopenic Purpura

Intervention(s)

Drug: E5501 40 mg 2 x 20-mg tablets, orally, with food

Drug: E5501 40mg 2 x 20-mg tablets, orally, fasted

Drug: E5501 40 mg 2 x 20-mg tablets, orally, with food

Drug: E5501 40 mg 2 x 20-mg tablets, orally, fasted

Primary Outcome(s)

Area under the plasma concentration-time course profile (AUC) and maximum observed plasma concentration (Cmax) under fasted and fed conditions [Time Frame: 8 weeks]

Secondary Outcome(s)

To evaluate the comparison of the overall effect of food on the bioavailability of E5501 relative to the fasted condition as measured by AUC(0-inf) and Cmax [Time Frame: 8 weeks]

Secondary ID(s)

E5501-G000-010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors