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

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ClinicalTrials.gov Identifier: NCT03424577
Recruitment Status : Completed
First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
H3 Biomedicine Inc.
Information provided by (Responsible Party):
Eisai Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Participants Drug: H3B-6527 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Randomized Phase 1 Food-Effect Study of H3B-6527 in Healthy Subjects
Actual Study Start Date : December 27, 2017
Actual Primary Completion Date : January 27, 2018
Actual Study Completion Date : January 27, 2018

Arm Intervention/treatment
Experimental: 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).
Drug: H3B-6527
Oral capsule




Primary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03424577


Locations
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United States, Texas
Worldwide Clinical Trials
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Eisai Inc.
H3 Biomedicine Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT03424577    
Other Study ID Numbers: H3B-6527-A001-001
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eisai Inc.:
H3B-6527
Healthy Participants
Pharmacokinetics