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

A Single-center, Randomized, Open-label, Two-part Study to Evaluate Bioavailability of Prototype Third-generation Formulations of E5501 Relative to Second-generation Tablet Formulation in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01549054

Enrollment

Registered

2012-03-08

Start date

2012-01-31

Completion date

2012-08-31

Last updated

2013-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Thrombocytopenic Purpura

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.

Interventions

DRUG10-mg dose of E5501 2G tablet

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

DRUG10-mg dose of E5501 cyclodextrin oral solution

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

DRUG10-mg dose of E5501-P21% powder

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

DRUG10-mg dose of E5501 lipid-based oral

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

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 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.

Design outcomes

Primary

Measure	Time frame
Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax	133 days

Secondary

Measure	Time frame
Change in plasma concentrations of drug for each dose over time as measured by AUC, CMAX, TMax with and without food	133 days

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026