Healthy Participants
Conditions
Keywords
H3B-6527, Healthy Participants, Pharmacokinetics
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.
Interventions
DRUGH3B-6527
Oral capsule
Sponsors
H3 Biomedicine Inc.
Eisai Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Countries
United States
Outcome results
None listed