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Completed

NCT Number: NCT03424577

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.

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Key information

Conditions

Healthy Participants

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

H3B-6527

Drug

Oral capsule

Primary outcomes

  1. Mean area under the plasma-concentration time curve from time 0 through the last measurable concentration (AUC0-t) of H3B-6527

    Time frame: 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

  2. Mean area under the plasma concentration-time of maximum observed last measurable concentration (tmax) of H3B-6527

    Time frame: 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

  3. Mean maximum observed plasma concentration (Cmax) of H3B-6527

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Collaborators

  • H3 Biomedicine Inc.

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 7, 2018
Registry last updated
Feb 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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