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A Study of Oral Hymecromone and Hyaluronan Synthesis

Primary Purpose

Healthy, Respiratory Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

hymecromone

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Stanford University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Oral hymecromone 400mg po three times per day

Oral hymecromone 800 mg po three times per day (2400 mg)

Oral hymecromone 1200 mg three times per day (3600 mg)

Arm Description

Participants will be administered oral hymecromone 400mg po three times per day (1200 mg)

Participants will be be administered oral hymecromone 800 mg po three times per day (2400 mg)

Participants will be administered oral hymecromone 1200 mg three times per day (3600 mg)

Outcomes

Primary Outcome Measures

Change in sputum hyaluronan concentration over the study period

Change in serum hyaluronan concentration over the study period

Change in serum hymecromone concentration over the study period

Secondary Outcome Measures

The safety and tolerability (as codified by Common Terminology Criteria for Adverse Events (CTCAE) v5.0) of oral hymecromone over the study period

Full Information

NCT ID

NCT02780752

First Posted

May 17, 2016

Last Updated

June 11, 2021

Sponsor

Paul Bollyky

1. Study Identification

Unique Protocol Identification Number

NCT02780752

Brief Title

A Study of Oral Hymecromone and Hyaluronan Synthesis

Official Title

Dose Ranging Studies of Oral Hymecromone on Hyaluronan Synthesis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

December 1, 2020 (Actual)

Primary Completion Date

May 10, 2021 (Actual)

Study Completion Date

May 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Paul Bollyky

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy, Respiratory Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Participants will be assigned to one of three treatment groups, each including up to 6 participants, with treatment over 4 days of different doses of oral hymecromone. Following a wash-out period, participants are allowed to re-enroll into different treatment groups to provide intra-patient dose comparisons.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral hymecromone 400mg po three times per day

Arm Type

Active Comparator

Arm Description

Participants will be administered oral hymecromone 400mg po three times per day (1200 mg)

Arm Title

Oral hymecromone 800 mg po three times per day (2400 mg)

Arm Type

Active Comparator

Arm Description

Participants will be be administered oral hymecromone 800 mg po three times per day (2400 mg)

Arm Title

Oral hymecromone 1200 mg three times per day (3600 mg)

Arm Type

Active Comparator

Arm Description

Participants will be administered oral hymecromone 1200 mg three times per day (3600 mg)

Intervention Type

Drug

Intervention Name(s)

hymecromone

Other Intervention Name(s)

4-Methylumbelliferone

Intervention Description

Oral Hymecromone

Primary Outcome Measure Information:

Title

Change in sputum hyaluronan concentration over the study period

Time Frame

From baseline to day 4

Title

Change in serum hyaluronan concentration over the study period

Time Frame

From baseline to day 4

Title

Change in serum hymecromone concentration over the study period

Time Frame

From baseline to day 4

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Bollyky, MD

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35499083

Citation

Rosser JI, Nagy N, Goel R, Kaber G, Demirdjian S, Saxena J, Bollyky JB, Frymoyer AR, Pacheco-Navarro AE, Burgener EB, Rajadas J, Wang Z, Arbach O, Dunn CE, Kalinowski A, Milla CE, Bollyky PL. Oral hymecromone decreases hyaluronan in human study participants. J Clin Invest. 2022 May 2;132(9):e157983. doi: 10.1172/JCI157983.

Results Reference

derived

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A Study of Oral Hymecromone and Hyaluronan Synthesis

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