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NCT Number: NCT02289599

A Study to Assess Safety, Tolerability, and Pharmacokinetics of E2307 in Healthy Young and Elderly Japanese Subjects

This study will be a single-center, single dose, randomized, double-blind, placebo-controlled study in healthy Japanese male subjects. The study will consist of 2 parts: Part A (young subjects) and Part B (elderly subjects). In Part A sequential cohorts of subjects will be treated with single ascending doses of E2307. The maximum tolerated dose (MTD) will be determined in Part A. Part B will be initiated after Part A is completed. In Part B one cohort of healthy elderly subjects will be treated with a single dose of E2307 at one dose level below the MTD. In part A, a total of 56 subjects will be enrolled into 7 cohorts sequentially and randomized 3:1 to receive either E2307 (1 mg, 3 mg, 10 mg, 30 mg, 100 mg, 200 mg, or 300 mg) or placebo. In part B, a total of 8 subjects will be randomized, 6 subjects to a single dose of E2307 and 2 subjects to placebo.

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Key information

Conditions

Healthy Subjects

Age range

20 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Kagoshima, Kagoshima-ken, Japan

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Parts A and B

  • Provide written informed consent
  • Willing and able to comply with all aspects of the protocol

Part A: Young cohort

  • Non-smoking, male subjects age >=20 years and less than 55 years old at the time of informed consent

Part B: Elderly Cohort

  • Non-smoking, male subjects age >=65 years and less than 85 years old at the time of informed consent

Exclusion criteria

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

  • Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks of dosing
  • Any history of abdominal surgery that may affect PK profiles of E2307 (eg. hepatectomy, nephrectomy, digestive organ resection)
  • Known history of clinically significant drug allergy (at Screening)

Treatment and study plan

E2307

Drug

E2307 Matching Placebo

Drug

Primary outcomes

  1. Number of adverse events/serious adverse events

    Time frame: Up to 30 days

  2. Plasma pharmacokinetics (PK) of E2307: Cmax (maximum observed concentration)

    Time frame: Up to 12 days

  3. Plasma PK of E2307: tmax (time at which the highest drug concentration occurs)

    Time frame: Up to 12 days

  4. Plasma PK of E2307: AUC(0-t) [area under the concentration (AUC)-time curve from zero time to time of last quantifiable concentration]

    Time frame: Up to 12 days

  5. Plasma PK of E2307: AUC(0-inf) [area under the concentration-time curve from zero time extrapolated to infinite time]

    Time frame: Up to 12 days

  6. Plasma PK of E2307: t1/2 (terminal elimination phase half-life)

    Time frame: Up to 12 days

  7. Plasma PK of E2307: CL/F (apparent total clearance following oral administration)

    Time frame: Up to 12 days

    CL/F are calculated for E2307 only

  8. Plasma PK of E2307: Vz/F (apparent volume of distribution at terminal phase)

    Time frame: Up to 12 days

    Vz/F are calculated for E2307 only

  9. Plasma PK of E2307: AUC ratio (AUC ratio of metabolite to parent)

    Time frame: Up to 12 days

  10. Urine PK of E2307: Ae (cumulative amount of drug excreted in urine up to 264 hours postdose)

    Time frame: Up to 12 days

  11. Urine PK of E2307: CLR (renal clearance)

    Time frame: Up to 12 days

Secondary outcomes

  1. Mean difference in change of mean blood pressure (BP) between E2307 and placebo

    Time frame: 24 hours predose and continue until 24 hours postdose (Day 2)

  2. QT interval assessment using Holter monitoring

    Time frame: 24 hours predose through Day 2 (at 24 hours postdose)

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled, Single-Ascending Dose Study to Assess Safety, Tolerability, and Pharmacokinetics of E2307 in Healthy Young and Elderly Japanese Subjects

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 13, 2014
Registry last updated
Jan 18, 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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