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

NCT02268838 | Completed Phase 1

• 1 other identifier: E6007-J081-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

E6007; Healthy Japanese male subjects

Outcome Measures

Primary Outcomes (10)

• Safety and tolerability of E6007 as a measure of Adverse events

  Screening and up to 17 days after last administration of drug

• Plasma E6007 concentration over time period - Cmax (maximum concentration)

  Up to 15 days

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

  Up to 15 days

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

  Up to 15 days

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

  Up to 15 days

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

  Up to 15 days

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

  Up to 15 days

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

  Up to 15 days

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

  Up to 15 days

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

  Up to 15 days

Secondary Outcomes (3)

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

  Up to 15 days

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

  Up to 5 days

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

  Up to 15 days

Study Arms (5)

50 mg E6007 fasted condition

EXPERIMENTAL

E6007 50mg or E6007 matching placebo x 1, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period.

Drug: E6007; Drug: E6007 matching placebo

100 mg E6007 fasted condition

EXPERIMENTAL

E6007 50mg or E6007 matching placebo x 2, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period.

Drug: E6007; Drug: E6007 matching placebo

200 mg E6007 fasted condition

EXPERIMENTAL

E6007 50mg or E6007 matching placebo x 4, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period.

Drug: E6007; Drug: E6007 matching placebo

400 mg E6007 fasted condition

EXPERIMENTAL

E6007 50mg or E6007 matching placebo x 8, orally once daily in the morning under fasted condition. Drug administration on 1 day for single dose period (Day 1) and 7 days (Day 5 to 11) for repeated dose period.

Drug: E6007; Drug: E6007 matching placebo

200 mg E6007 fed condition

EXPERIMENTAL

E6007 50mg or E6007 matching placebo x 4, orally once daily in the morning under fed condition. Drug administration on 1 day (Day 1).

Drug: E6007; Drug: E6007 matching placebo

Interventions

E6007 DRUG

100 mg E6007 fasted condition; 200 mg E6007 fasted condition; 200 mg E6007 fed condition; 400 mg E6007 fasted condition; 50 mg E6007 fasted condition

E6007 matching placebo DRUG

100 mg E6007 fasted condition; 200 mg E6007 fasted condition; 200 mg E6007 fed condition; 400 mg E6007 fasted condition; 50 mg E6007 fasted condition

Eligibility Criteria

• Age: 20 Years - 44 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Sumida-ku, Tokyo, Japan

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: October 20, 2014
• Study Start: October 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 20, 2016

Record last verified: 2015-12

Locations

JP (1)