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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: H3B-6527

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78217
      • Worldwide Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Collaborators: H3 Biomedicine Inc.

Publications and helpful links

General Publications

• Rioux N, Kim A, Nix D, Bowser T, Warmuth M, Smith PG, Schindler J. Effect of a high-fat meal on the relative bioavailability of H3B-6527, a novel FGFR4 inhibitor, in healthy volunteers. Cancer Chemother Pharmacol. 2019 Jan;83(1):91-96. doi: 10.1007/s00280-018-3708-3. Epub 2018 Oct 27.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 27, 2017
• Primary Completion (ACTUAL): January 27, 2018
• Study Completion (ACTUAL): January 27, 2018

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 1, 2018
• First Posted (ACTUAL): February 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 7, 2018
• Last Update Submitted That Met QC Criteria: February 1, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Healthy Participants; H3B-6527
• Other Study ID Numbers: H3B-6527-A001-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No