A Study to Evaluate the Food-Effect of H3B-6527

• Status: Completed
• Trial end date: 2018-01-27
• Target enrollment: 0
• Participant gender: Male

Summary

This study will be conducted to determine the effect of food on the relative bioavailability of H3B-6527 following administration of a H3B-6527 capsule with and without a meal.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eisai Inc.
• Collaborator: H3 Biomedicine Inc.

Criteria

Inclusion Criteria:

• Non-smoking, healthy male between the ages of 18 and 55 years old

• Body mass index (BMI) >18 and ≤ 29 kilograms per meters squared (kg/m^2)

• Participants who have not had a successful vasectomy and are partners of women of childbearing potential must use a medically effective method of contraception with their partner during the study period through 30 days after the last dose of study drug. No sperm donation is allowed during the study period or for 30 days after study drug discontinuation

Exclusion Criteria:

• Participants with clinically significant heart, liver, gastrointestinal, kidney, lung, hormonal, blood, nerve or psychiatric disease or history of gastrointestinal surgery or gall bladder removal that could effect the uptake, distribution or elimination of H3B-6527

• Participants with a history of drug or alcohol misuse within 6 months prior to screening or a positive urine drug test

• Participants diagnosed with acquired immune deficiency syndrome (AIDS), or who test positive for human immunodeficiency virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV)

• Participated in another clinical trial less than 4 weeks prior to dosing or is currently enrolled in another clinical trial

• Received blood products within 4 weeks, or donated blood within 8 weeks, or donated plasma within 1 week prior to the first dose

• Participants used any prescription or over-the-counter drugs within 2 weeks prior to the first dose