Human Salivary Gland Disposition of Alda-341 in Patients Undergoing Salivary Gland Surgery

NCT04296266 | Completed Early Phase 1 FDA Drug

• 1 other identifier: IRB-32994
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is determine salivary gland disposition of d-limonene, the primary component in citrus peel and a common dietary supplement. Salivary gland tissue and saliva will be collected to determine concentration of d-limonene and its metabolites in these tissues.

Conditions

Submandibular Gland Tumor; Parotid Gland Tumor

Outcome Measures

Primary Outcomes (1)

• Bioavailability of Alda-341 in salivary gland tissue using GCMS

  Bio availability of Alda-341 in salivary gland tissue will be measured using gas chromatography mass spectrometry (GCMS). The scale is is 4ng/mL - 8000ng/mL.

  2 week

Secondary Outcomes (1)

• Bioavailability of Alda-341 in saliva and blood

  2 week

Study Arms (1)

Alda-341 treatment

EXPERIMENTAL

Alda-341 treatment at 2 g/day for 14 days up until the day before regular medical care surgery.

Drug: Alda-341

Interventions

Alda-341 DRUG

Dietary supplement d-limonene orally administered as a drug.

Also known as: d-limonene

Alda-341 treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elected to undergo surgery for recent diagnosis of parotid or submandibular gland tumor
• Ability to adhere to study visit schedule and other protocol requirements
• Operable candidate base on the surgeon's note
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Nursing or pregnant
• Diagnosis of kidney disease, history of renal disease with creatinine \> 1.5 mg/dL, or currently on dialysis
• Diagnosis of end stage liver disease
• Any unstable medical condition
• Use of chemotherapy or radiotherapy within 4 weeks before first dose of study dietary supplement
• Unwilling to stop dietary supplements 3 weeks before first dose of study dietary supplement

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

MeSH Terms

Conditions

Submandibular Gland Neoplasms; Parotid Neoplasms

Interventions

Limonene

Condition Hierarchy (Ancestors)

Salivary Gland Neoplasms; Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Submandibular Gland Diseases; Parotid Diseases

Intervention Hierarchy (Ancestors)

Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Monoterpenes; Terpenes

Study Officials

• Quynh-Thu Le, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: March 5, 2020
• Study Start: February 1, 2016
• Primary Completion: December 18, 2017
• Study Completion: December 21, 2017
• Last Updated: March 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)