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

Study Overview
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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.

Official Title
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A Randomized Phase 1 Food-Effect Study of H3B-6527 in Healthy Subjects

Conditions
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Healthy Participants

Intervention / Treatment
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* Drug: H3B-6527


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: H3B-6527<br>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). | Drug: H3B-6527<br>* Oral capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean area under the plasma-concentration time curve from time 0 through the last measurable concentration (AUC0-t) of H3B-6527 |  | Days 1 and 5: Pre-dose, and 1, 2, 3, 4, 8, 12, and 16 hours postdose. Days 2 and 6: 24 and 36 hours postdose | 
| Mean area under the plasma concentration-time of maximum observed last measurable concentration (tmax) of H3B-6527 |  | Days 1 and 5: Pre-dose, and 1, 2, 3, 4, 8, 12, and 16 hours postdose. Days 2 and 6: 24 and 36 hours postdose | 
| Mean maximum observed plasma concentration (Cmax) of H3B-6527 |  | Days 1 and 5: Pre-dose, and 1, 2, 3, 4, 8, 12, and 16 hours postdose. Days 2 and 6: 24 and 36 hours postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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H3B-6527, Healthy Participants, Pharmacokinetics