NCT03424577

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2017

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 27, 2017

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 1, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2018

Completed
Last Updated

February 7, 2018

Status Verified

February 1, 2018

Enrollment Period

1 month

First QC Date

February 1, 2018

Last Update Submit

February 1, 2018

Conditions

Healthy Participants

Keywords

H3B-6527Healthy ParticipantsPharmacokinetics

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

H3B-6527

EXPERIMENTAL

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

Interventions

H3B-6527DRUG

Oral capsule

H3B-6527

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Location

Related Publications (1)

  • 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.

    PMID: 30368584DERIVED

MeSH Terms

Interventions

H3B-6527

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2018

First Posted

February 7, 2018

Study Start

December 27, 2017

Primary Completion

January 27, 2018

Study Completion

January 27, 2018

Last Updated

February 7, 2018

Record last verified: 2018-02

Locations

US(1)