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

Stanford University

Status and phase: Completed; Early Phase 1

Conditions: Parotid Gland Tumor; Submandibular Gland Tumor

Treatments: Drug: Alda-341

Study type: Interventional

Funder types: Other

Identifiers

NCT04296266

IRB-32994

Details and patient eligibility

About

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.

Full 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

Enrollment: 10 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Alda-341 treatment

Experimental group

Description:

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

Treatment:

Drug: Alda-341