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OpenTrials
Completed

NCT Number: NCT01716897

An Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption

This study will be a single-center, open-label, randomized, 3-treatment crossover study of single oral doses of an API-capsule formulation of E2609 under fasted conditions and a tablet formulation administered under fed and fasted conditions in healthy subjects.

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Key information

Age range

30 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

California Clinical Trials/Parexel

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Caucasian males defined as persons of a European or Latin American descent
  • Healthy male 30 to 55 years inclusive at the time of informed consent
  • Body mass index (BMI) of 18 to 32 kg/m2 at Screening
  • Subjects must have had a successful vasectomy (confirmed azoospermia), or they and their female partners must not be of childbearing potential or must be practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation. No sperm donation is allowed during the study period and for 30 days after study drug discontinuation.

Exclusion criteria

  • Any history of seizures or epilepsy (not including a history of simple febrile seizures in childhood) or disturbance of consciousness likely to be due to seizures
  • Any medical condition which, in the opinion of the investigator has high risk of seizures (e.g., history of traumatic brain injury associated with loss of consciousness or amnesia, alcohol abuse, substance abuse) at Screening or within past 5 years
  • Any history of cerebrovascular disease (stroke or transient ischemic attack)
  • A history of prolonged QT/QTc interval or prolonged period from the beginning of the QRS complex to the end of the T wave on an ECG (QT)/ QT corrected for heart rate using Fridericia?s formula (QTcF) interval (QTcF > 450 ms) as demonstrated by the mean of triplicate electrocardiogram (ECGs) (recorded at least 1 min apart) at Screening or Baseline Period
  • Any other clinically significant ECG abnormalities at Screening or Baseline Periods, e.g. component of the ECG cycle from onset of atrial depolarization to onset of ventricular depolarization (PR)>220 ms, component of ECG wave representing ventricular depolarization (QRS)>110 ms
  • Hypersensitivity to the study drugs or any of their excipients

Treatment and study plan

E2609

Drug

Primary outcomes

  1. AUC(0-inf) ratio, new tablet vs. capsule

    Time frame: 0 -144 hours

  2. AUC(0-inf) ratio, fed state vs. fasted state, both after administration of new tablet

    Time frame: 0 - 144 hours

  3. Cmax ratio, new tablet vs. capsule

    Time frame: 0 - 144 hours

  4. Cmax ratio, fed state vs. fasted state, both after administration of new tablet

    Time frame: 0 - 144 hours

Secondary outcomes

  1. incidence of Adverse events

    Time frame: 5.5 weeks

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study title

A Randomized, Open-label, 3-treatment Crossover Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption in Healthy Caucasian Male Adults

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Oct 30, 2012
Registry last updated
May 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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