Clinical trial NCT03424577: A Study to Evaluate the Food-Effect of H3B-6527
Official title: A Randomized Phase 1 Food-Effect Study of H3B-6527 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: H3B-6527
Healthy Participants
Pharmacokinetics
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
Collaborators: name: H3 Biomedicine Inc.
First posted: 2018-02-07
Enrollment: 17
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Mean area under the plasma-concentration time curve from time 0 through the last measurable concentration (AUC0-t) of H3B-6527
timeFrame: 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
measure: Mean area under the plasma concentration-time of maximum observed last measurable concentration (tmax) of H3B-6527
timeFrame: 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
measure: Mean maximum observed plasma concentration (Cmax) of H3B-6527
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Worldwide Clinical Trials
state: Texas
Study officials:
References:
citation: 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.