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NCT Number: NCT02780752

A Study of Oral Hymecromone and 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.

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Key information

Conditions

Healthy Respiration Disorders Respiratory Disease Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Stanford University

Palo Alto, California, 94304, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hymecromone

Drug

Oral Hymecromone

Other names: 4-Methylumbelliferone

Primary outcomes

  1. Change in sputum hyaluronan concentration over the study period

    Time frame: From baseline to day 4

  2. Change in serum hyaluronan concentration over the study period

    Time frame: From baseline to day 4

  3. Change in serum hymecromone concentration over the study period

    Time frame: From baseline to day 4

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Paul Bollyky

Other

Registry information

Official study title

Dose Ranging Studies of Oral Hymecromone on Hyaluronan Synthesis

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 23, 2016
Registry last updated
Jun 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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