A Study of Oral Hymecromone and Hyaluronan Synthesis

• Register: ClinicalTrials.gov
• Last refreshed on: 21 June 2021
• Main ID: NCT02780752
• Date of registration: 17/05/2016
• Prospective Registration: Yes
• Primary sponsor: Paul Bollyky
• Public title: A Study of Oral Hymecromone and Hyaluronan Synthesis
• Scientific title: Dose Ranging Studies of Oral Hymecromone on Hyaluronan Synthesis
• Date of first enrolment: December 1, 2020
• Target sample size: 12
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02780752
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Paul Bollyky, MD
• Affiliation: Stanford University

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Respiratory Disease

Healthy

Intervention(s)

Drug: hymecromone

Primary Outcome(s)

Change in serum hymecromone concentration over the study period [Time Frame: From baseline to day 4]

Change in serum hyaluronan concentration over the study period [Time Frame: From baseline to day 4]

Change in sputum hyaluronan concentration over the study period [Time Frame: From baseline to day 4]

Secondary Outcome(s)

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]

Secondary ID(s)

IRB-43805

Source(s) of Monetary Support

Please refer to primary and secondary sponsors