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

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ClinicalTrials.gov Identifier: NCT02289599
Recruitment Status : Completed
First Posted : November 13, 2014
Last Update Posted : January 18, 2016
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Drug: E2307 Drug: E2307 Matching Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Study Start Date : November 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : July 2015

Arm Intervention/treatment
Experimental: Part A: 1 mg E2307 (young cohort)
E2307 (1 x 1 mg E2307 capsule) or placebo (1 x 1 E2307 matching placebo capsule)
Drug: E2307
Drug: E2307 Matching Placebo
Experimental: Part A: 3 mg E2307 (young cohort)
E2307 (3 x 1 mg E2307 capsules) or placebo (3 x 1 E2307 matching placebo capsules)
Drug: E2307
Drug: E2307 Matching Placebo
Experimental: Part A: 10 mg E2307 (young cohort)
E2307 (1 x 10 mg E2307 capsule) or placebo (1 x 1 E2307 matching placebo capsule)
Drug: E2307
Drug: E2307 Matching Placebo
Experimental: Part A: 30 mg E2307 (young cohort)
E2307 (3 x 10 mg E2307 capsules) or placebo (3 x 1 E2307 matching placebo capsules)
Drug: E2307
Drug: E2307 Matching Placebo
Experimental: Part A: 100 mg E2307 (young cohort)
E2307 (1 x 100 mg E2307 capsule) or placebo (1 x 1 E2307 matching placebo capsule)
Drug: E2307
Drug: E2307 Matching Placebo
Experimental: Part A: 200 mg E2307 (young cohort)
E2307 (2 x 100 mg E2307 capsules) or placebo (2 x 1 E2307 matching placebo capsules)
Drug: E2307
Drug: E2307 Matching Placebo
Experimental: Part A: 300 mg E2307 (young cohort)
E2307 (3 x 100 mg E2307 capsules) or placebo (3 x 1 E2307 matching placebo capsules)
Drug: E2307
Drug: E2307 Matching Placebo
Experimental: Part B: Elderly cohort
One dose level below MTD from Part A
Drug: E2307



Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Parts A and B

  1. Provide written informed consent
  2. Willing and able to comply with all aspects of the protocol

    Part A: Young cohort

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

    Part B: Elderly Cohort

  4. 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02289599


Locations
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Japan
Kagoshima, Japan
Sponsors and Collaborators
Eisai Co., Ltd.

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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT02289599     History of Changes
Other Study ID Numbers: E2307-J081-001
First Posted: November 13, 2014    Key Record Dates
Last Update Posted: January 18, 2016
Last Verified: January 2016
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Healthy Japanese Subjects
E2307
Pharmacokinetics