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NCT Number: NCT02268838

Single/ Multiple-Dose Study of E6007 in Healthy Japanese Male Subjects

This is a single-center, placebo-controlled, randomized, ascending dose, double-blind study. This study will be evaluating ascending doses of 50, 100, 200, and 400 mg of E6007. This study consists of 5 steps, 1 to 5. In steps 1 to 4 (at ascending doses of 50, 100, 200, and 400 mg), subjects will be randomly assigned in a 6:2 ratio (E6007: placebo) to receive single dose of the study drug under fasted condition. Following 3 days of washout period, subject will receive the study drug once daily for 7 days starting on the fifth day from the single dose administration.

For step 3 (200 mg), subjects will subsequently have at least 17 days of washout period before being escalated to step 5 (200 mg) to receive single dose of E6007 under fed condition, to evaluate food effect of the study drug.

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Key information

Conditions

Healthy Volunteers

Age range

20 year–44 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Sumida-ku, Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Subjects must meet all of the following criteria to be included in this study:

  • Healthy Japanese male subjects aged 20 to 44 years at the time of informed consent.
  • Has voluntarily consented, in writing, to participate in this study.
  • Has been thoroughly briefed on the conditions for participation in the study, and is willing and able to comply with the conditions.

Exclusion criteria

Subjects who meet any of the following criteria will be excluded from this study:

  • Has a clinically significant medical condition requiring treatment within 8 weeks before the initial study drug administration, or a history of clinically significant infection requiring treatment within 4 weeks before the initial drug administration.
  • History of surgical treatment such as resection of the liver, kidney, or Gastrointestinal tract, that may affect the Pharmacokinetic profiles of study drugs.
  • Ineligible for study participation in the opinion of the investigator or sub-investigator.

Treatment and study plan

E6007

Drug

E6007 matching placebo

Drug

Primary outcomes

  1. Safety and tolerability of E6007 as a measure of Adverse events

    Time frame: Screening and up to 17 days after last administration of drug

  2. Plasma E6007 concentration over time period - Cmax (maximum concentration)

    Time frame: Up to 15 days

  3. Plasma E6007 concentration over time period - tmax (Time to achieve maximum concentration (Cmax))

    Time frame: Up to 15 days

  4. Plasma E6007 concentration over time period - AUC (0-t) (Area Under the Curve (AUC) from Time Zero to Last Quantifiable Concentration)

    Time frame: Up to 15 days

  5. Plasma E6007 concentration over time period - AUC (0-inf) (AUC extrapolated to infinity)

    Time frame: Up to 15 days

  6. Plasma E6007 concentration over time period - t1/2 (Terminal phase half-life)

    Time frame: Up to 15 days

  7. Plasma E6007 concentration over time period - CL/F (Apparent clearance)

    Time frame: Up to 15 days

  8. Plasma E6007 concentration over time period - Vz/F (Apparent volume of distribution)

    Time frame: Up to 15 days

  9. Plasma E6007 concentration over time period - Css,max (maximum steady state concentration)

    Time frame: Up to 15 days

  10. Plasma E6007 concentration over time period - AUC (0-tau) (AUC from time zero to time tau over a dosing interval at steady state)

    Time frame: Up to 15 days

Secondary outcomes

  1. Dose proportionality under fasted conditions with Cmax, AUC (0-t), AUC(0-inf), Cssmax and AUC(0-t)

    Time frame: Up to 15 days

  2. Geometric mean proportion (fed:fasted) of Cmax, AUC(0-t) and AUC(0-inf) for 200mg E6007 dose

    Time frame: Up to 5 days

  3. Evaluate relationship between E6007 plasma concentrations and electrocardiogram (ECG) parameter (QTcF)

    Time frame: Up to 15 days

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

A Phase 1 Single/ Multiple-Dose Study of E6007 in Healthy Japanese Male Subjects

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 20, 2014
Registry last updated
Jan 20, 2016

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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