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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-27

Study Completion Date

2018-01-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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H3B-6527

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).

Group Type EXPERIMENTAL

H3B-6527

Intervention Type DRUG

Oral capsule

Interventions

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H3B-6527

Oral capsule

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes