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

Eisai

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: H3B-6527

Study type: Interventional

Funder types: Industry

Identifiers

NCT03424577

H3B-6527-A001-001

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

H3B-6527

Experimental group

Description:

Healthy male participants will be randomly assigned to 1 of 2 possible treatment sequences: either H3B-6527 capsule with food on Day 1 and H3B-6527 capsule without food on Day 5 (treatment sequence fed/fasted), or H3B-6527 capsule without food on Day 1 and H3B-6527 capsule with food on Day 5 (treatment sequence fasted/fed).

Treatment:

Drug: H3B-6527