A Study in Healthy Subjects to Evaluate Bioavailability of 4 Formulations of E5501

NCT01549054 | Completed Phase 1

• 1 other identifier: E5501-G000-012
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study in healthy subjects. There are two parts to the study. In the first part of the study each subject will receive a single 10mg dose of each of the four formulations of E550. Based on the results from Part 1, an optimal formulation will be selected for further evaluation in Part 2.

Conditions

Idiopathic Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (1)

• Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax

  133 days

Secondary Outcomes (1)

• Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax with and without food

  133 days

Study Arms (4)

10-mg dose of E5501 2G tablet

EXPERIMENTAL

Drug: 10-mg dose of E5501 2G tablet

10-mg dose of E5501 cyclodextrin oral solution

EXPERIMENTAL

Drug: 10-mg dose of E5501 cyclodextrin oral solution

10-mg dose of E5501-P21% powder

EXPERIMENTAL

Drug: 10-mg dose of E5501-P21% powder

10-mg dose of E5501 lipid-based oral

EXPERIMENTAL

Drug: 10-mg dose of E5501 lipid-based oral

Interventions

10-mg dose of E5501 2G tablet DRUG

Treatment A: Single 10-mg dose of E5501 2G tablet

10-mg dose of E5501 2G tablet

10-mg dose of E5501 cyclodextrin oral solution DRUG

Treatment B: Single 10-mg dose of E5501 cyclodextrin oral solution

10-mg dose of E5501 cyclodextrin oral solution

10-mg dose of E5501-P21% powder DRUG

Treatment C: Single 10-mg dose of E5501-P21% powder oral suspension

10-mg dose of E5501-P21% powder

10-mg dose of E5501 lipid-based oral DRUG

Treatment D: Single 10-mg dose of E5501 lipid-based oral suspension

10-mg dose of E5501 lipid-based oral

Eligibility Criteria

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

You may qualify if:

• Healthy adult men and women (age ≥ 18 to ≤ 55 years)
• Body mass index ≥ 18.0 kg/m2 and ≤ 32.0 kg/m2 at the time of screening and baseline of Treatment Period 1
• Platelet count between 120 x 109/L and 300 x 109/L at baseline of each Treatment Period 1, 3, and 5
• Women of child bearing potential must agree to use a highly effective method of contraception, other than estrogen-based hormonal contraceptives, during the Treatment Phase of the study.
• In addition, other standard criteria for healthy subjects will be used.

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 the PK of 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 event or illness in the subject's medical history, e.g., history of splenectomy.
• History of arterial or venous thrombosis, including partial or complete thrombosis (e.g., stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis, or pulmonary embolism). Known family history of hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency, etc.)
• Hemoglobin less than the lower limit of normal levels.
• In addition, other standard criteria for healthy subjects will be used.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Quotient

Nottingham, United Kingdom

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

• Bhaskar Rege

  Eisai Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: March 8, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

GB (1)