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

NCT01327872 | Completed Phase 1

• 1 other identifier: E5501-G000-010
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a randomized, open-label, four-group, two-period, replicate design study to evaluate the effect of food on within and between subject variability in second generation formulation 20-mg tablet strengths, Lots P01008ZZA and P01009ZZA, administered as single doses of 40mg to 84 healthy male and female subjects. The study is powered to detect both a reduction in either the within or between subject variability (coefficient of variation \[CV\]%) of approximately 35%.

Conditions

Purpura, Thrombocytopenic, Idiopathic; Acute Idiopathic Thrombocytopenic Purpura; Chronic Thrombocytopenia

Keywords

Idiopathic Thrombocytopenia Purpura(ITP); Acute and Chronic Thrombocytopenia Associated with Chronic Liver Disease; TLD

Outcome Measures

Primary Outcomes (1)

• Area under the plasma concentration-time course profile (AUC) and maximum observed plasma concentration (Cmax) under fasted and fed conditions

  8 weeks

Secondary Outcomes (1)

• 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

  8 weeks

Study Arms (4)

Treatment A

EXPERIMENTAL

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

Treatment B

EXPERIMENTAL

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

Treatment C

EXPERIMENTAL

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

Treatment D

EXPERIMENTAL

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

Interventions

E5501 40 mg 2 x 20-mg tablets, orally, fasted DRUG

single 40 mg dose (2 x 20-mg tablets) of Lot P01008ZZA in the fasted condition

Treatment A

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

single 40 mg dose (2 x 20-mg tablets) of Lot P01008ZZA in the fed condition

Treatment B

E5501 40mg 2 x 20-mg tablets, orally, fasted DRUG

single 40 mg dose (2 x 20-mg tablets) of Lot P01009ZZA in the fasted condition

Treatment C

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

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 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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

PRA Early Development Services

Zuidlaren, Netherlands

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Tablets

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Franklin Johnson

  Eisai Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: April 4, 2011
• Study Start: February 1, 2011
• Primary Completion: April 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 9, 2012

Record last verified: 2012-03

Locations

NL (1)