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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03424577
• Other study ID #: H3B-6527-A001-001
• Status: Completed
• Phase: Phase 1
• First received: February 1, 2018
• Last updated: February 1, 2018
• Start date: December 27, 2017
• Est. completion date: January 27, 2018

Study information

• Verified date: February 2018
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 27, 2018
• Est. primary completion date: January 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• H3B-6527
Oral capsule

Locations

Country	Name	City	State
United States	Worldwide Clinical Trials	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Eisai Inc.	H3 Biomedicine Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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