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

Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02289599
• Other study ID #: E2307-J081-001
• Status: Completed
• Phase: Phase 1
• First received: November 10, 2014
• Last updated: January 15, 2016
• Start date: November 2014
• Est. completion date: July 2015

Study information

• Verified date: January 2016
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 85 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• E2307

• E2307 Matching Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events/serious adverse events		Up to 30 days	Yes
Primary	Plasma pharmacokinetics (PK) of E2307: Cmax (maximum observed concentration)		Up to 12 days	No
Primary	Plasma PK of E2307: tmax (time at which the highest drug concentration occurs)		Up to 12 days	No
Primary	Plasma PK of E2307: AUC(0-t) [area under the concentration (AUC)-time curve from zero time to time of last quantifiable concentration]		Up to 12 days	No
Primary	Plasma PK of E2307: AUC(0-inf) [area under the concentration-time curve from zero time extrapolated to infinite time]		Up to 12 days	No
Primary	Plasma PK of E2307: t1/2 (terminal elimination phase half-life)		Up to 12 days	No
Primary	Plasma PK of E2307: CL/F (apparent total clearance following oral administration)	CL/F are calculated for E2307 only	Up to 12 days	No
Primary	Plasma PK of E2307: Vz/F (apparent volume of distribution at terminal phase)	Vz/F are calculated for E2307 only	Up to 12 days	No
Primary	Plasma PK of E2307: AUC ratio (AUC ratio of metabolite to parent)		Up to 12 days	No
Primary	Urine PK of E2307: Ae (cumulative amount of drug excreted in urine up to 264 hours postdose)		Up to 12 days	No
Primary	Urine PK of E2307: CLR (renal clearance)		Up to 12 days	No
Secondary	Mean difference in change of mean blood pressure (BP) between E2307 and placebo		24 hours predose and continue until 24 hours postdose (Day 2)	No
Secondary	QT interval assessment using Holter monitoring		24 hours predose through Day 2 (at 24 hours postdose)	No