A Study of Oral Hymecromone and Hyaluronan Synthesis

NCT ID: NCT02780752

Last Updated: 2021-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-05-10

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.

Conditions

Healthy; Respiratory Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral hymecromone 400mg po three times per day

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

Group Type: ACTIVE_COMPARATOR

hymecromone

Intervention Type: DRUG

Oral Hymecromone

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)

Group Type: ACTIVE_COMPARATOR

hymecromone

Intervention Type: DRUG

Oral Hymecromone

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

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

Group Type: ACTIVE_COMPARATOR

hymecromone

Intervention Type: DRUG

Oral Hymecromone

Interventions

hymecromone

Oral Hymecromone

Intervention Type: DRUG

Other Intervention Names

4-Methylumbelliferone

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Paul Bollyky

OTHER

Sponsor Role: lead

Responsible Party

Paul Bollyky

Associate Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Paul Bollyky, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

References

Salman L, Martinez L, Faddoul G, Manning C, Ali K, Salman M, Vazquez-Padron R. Hyaluronan Inhibition as a Therapeutic Target for Diabetic Kidney Disease: What Is Next? Kidney360. 2023 Jun 1;4(6):e851-e860. doi: 10.34067/KID.0000000000000126. Epub 2023 Apr 14.

Reference Type: DERIVED

PMID: 37055910 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35499083 (View on PubMed)

Other Identifiers

IRB-43805

Identifier Type: -

Identifier Source: org_study_id