A Study of Oral Hymecromone and Hyaluronan Synthesis

June 11, 2021 updated by: Paul Bollyky

Dose Ranging Studies of Oral Hymecromone on Hyaluronan Synthesis

The purpose of this study is to add further understanding to the doses of hymecromone that effectively and safely lead to the inhibition of hyaluronan synthesis. In this study we will investigate both circulating hyaluronan in the serum, as well as tissue hyaluronan, using sputum samples as a non-invasive surrogate.

This is a parallel, open-label, single-center, dose-response study of hymecromone in healthy adults 18 years of age or older. Up to 18 participants will be enrolled. Participants will be treated for 4 days with study drug. Safety as well as biomarkers of pharmacokinetic and pharmacodynamic response will be monitored during therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female 18-65 years of age
  • Healthy adult with no active medical problems or significant chronic diseases as determined by the study doctor based on history, physical exam
  • BMI between 18.5 - 30 kg/m2
  • Taking no medications for at least 1 week before and during study enrollment, including drugs of abuse, prescription or OTC medications
  • Male subjects who are heterosexually active must use an acceptable method of contraception (abstinence, condom with or without spermicidal agent, or partner contraceptive use as described in requirements for female subjects) to avoid pregnancy in their partner for the entire study period
  • Female subjects who are heterosexually active must use an acceptable method of contraception: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, IUD, or Hormone-based contraceptive
  • Be able to provide written informed consent and comply with requirements of the study
  • Abstinence from alcoholic beverages, caffeinated beverages and orange juice from 3pm the night before a study day until completion of that study day
  • Be able to read, speak and understand English
  • Able and willing to understand the study, adhere to all study procedures, and provide written informed consent

Exclusion Criteria:

  • Subjects with a history of gastrointestinal disease including gastroesophageal reflux disease, gastritis, peptic ulcer disease or dyspepsia
  • Subjects with history of dysphagia, achalasia, or difficulty swallowing capsules, tablets or pills
  • Subjects with liver failure or LFTs above the upper limit of normal
  • Subjects with clinically significant elevations in SCr, BUN or other screening laboratory tests as determined by study physician
  • Subjects with a baseline corrected Fridericia's QT interval (QTcF) >450ms and a baseline ECG abnormalities which in the opinion of the study physician, is clinically significant
  • Subjects with ongoing alcohol or illegal drug use
  • Subjects who are pregnant, lactating or attempting to conceive
  • Known allergy to hymecromone or any component thereof
  • Physician concern that participant may not adhere to the study protocol
  • Current participation in another clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oral hymecromone 400mg po three times per day
Participants will be administered oral hymecromone 400mg po three times per day (1200 mg)
Drug: hymecromone
Oral Hymecromone
Other Names:
  • 4-Methylumbelliferone
Active Comparator: Oral hymecromone 800 mg po three times per day (2400 mg)
Participants will be be administered oral hymecromone 800 mg po three times per day (2400 mg)
Drug: hymecromone
Oral Hymecromone
Other Names:
  • 4-Methylumbelliferone
Active Comparator: Oral hymecromone 1200 mg three times per day (3600 mg)
Participants will be administered oral hymecromone 1200 mg three times per day (3600 mg)
Drug: hymecromone
Oral Hymecromone
Other Names:
  • 4-Methylumbelliferone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in sputum hyaluronan concentration over the study period
Time Frame: From baseline to day 4
From baseline to day 4
Change in serum hyaluronan concentration over the study period
Time Frame: From baseline to day 4
From baseline to day 4
Change in serum hymecromone concentration over the study period
Time Frame: From baseline to day 4
From baseline to day 4

Secondary Outcome Measures

Outcome Measure
Time Frame
The safety and tolerability (as codified by Common Terminology Criteria for Adverse Events (CTCAE) v5.0) of oral hymecromone over the study period
Time Frame: Through study completion, an average of 11 days
Through study completion, an average of 11 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paul Bollyky

Investigators

  • Principal Investigator: Paul Bollyky, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

May 10, 2021

Study Completion (Actual)

May 10, 2021

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

May 20, 2016

First Posted (Estimate)

May 23, 2016

Study Record Updates

Last Update Posted (Actual)

June 16, 2021

Last Update Submitted That Met QC Criteria

June 11, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-43805

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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