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A Study to Evaluate the Food-Effect of H3B-6527 | Clinical Trials | Clareo Health

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COMPLETEDPhase 1NCT03424577

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

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.

Lead sponsor: Eisai Inc.•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Eisai Inc.

Collaborators

H3 Biomedicine Inc.

Age

18 - 55 years

Sex

MALE

Healthy Volunteers

Yes

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 7, 2018Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment17

Start dateDec 2017

Last updatedFeb 7, 2018

Condition

Healthy Participants

Locations shown

Worldwide Clinical Trials

San Antonio, Texas

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2018Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions