NCT01289509

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 3, 2011

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

3 months

First QC Date

January 27, 2011

Last Update Submit

October 31, 2013

Conditions

Idiopathic Thrombocytopenia Purpura

Outcome Measures

Primary Outcomes (2)

  • • 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).

    96 hours post-dose

  • 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).

    96 hours post dose

Secondary Outcomes (2)

  • • To assess the intra-subject and inter-subject variability in Cmax following replicate dosing with E5501 40 mg lots

    10 weeks

  • • To assess the intra-subject and inter-subject variability in AUC(0-inf) following replicate dosing with E5501 40 mg lots.

    10 weeks

Study Arms (2)

Experimental 1

EXPERIMENTAL

Drug: E5501

Drug: E5501

Experimental 2

EXPERIMENTAL

Drug: E5501

Drug: Drug: E5501

Interventions

E5501DRUG

Lot P01010ZZA (test) single oral doses of 40 mg tablets.

Experimental 1
Drug: E5501DRUG

Lot P97001ZZB (reference) single oral doses of 40 mg tablets.

Experimental 2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PRA

Lenexa, Kansas, United States

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

avatrombopag

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Franklin Johnson

    Eisai Inc.

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 27, 2011

First Posted

February 3, 2011

Study Start

December 1, 2010

Primary Completion

March 1, 2011

Study Completion

May 1, 2011

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

US(1)