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

NCT04296266 — Early Phase 1, Completed, 10 participants, Stanford University

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Registry	NCT04296266
Status	Completed
Phase	Early Phase 1
Study type	Interventional; na, single group, masking: none, other
Enrollment	10 (Actual)
Sponsor	Stanford University (Other)
Conditions	Submandibular Gland Tumor, Parotid Gland Tumor
Interventions	Alda-341 (Drug)
Dates	start 2016-02-01, primary completion 2017-12-18, completion 2017-12-21, first posted 2020-03-05, last updated 2020-03-05
Locations	1 site in United States

-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.

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+Detailed description

Primary Objective: To determine the bioavailability of Alda-341 in salivary gland tissue.

Secondary Objective: To determine the bioavailability of Alda-341 in saliva and blood

+Arms and interventions

Arm	Type	Interventions	Description
Alda-341 treatment	Experimental	Drug: Alda-341	Alda-341 treatment at 2 g/day for 14 days up until the day before regular medical care surgery.

Alda-341 (Drug), also known as d-limonene: Dietary supplement d-limonene orally administered as a drug.

+Outcome measures

Primary outcomes

Bioavailability of Alda-341 in salivary gland tissue using GCMS [2 week]: 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.

Secondary outcomes

Bioavailability of Alda-341 in saliva and blood [2 week]: Bio availability of Alda-341 in saliva and blood will be measured using gas chromatography mass spectrometry (GCMS). The scale is is 4ng/mL - 8000ng/mL.

+Eligibility

Sex: All, ages: 18 Years to 85 Years

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

+Locations (1)

Facility	City	Country	Status
Stanford University	Stanford, California	United States

+Investigators

Quynh-Thu Le, MD, Principal investigator, Stanford University