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

Early Phase 1

Completed

• Conditions: Parotid Gland Tumor; Submandibular Gland Tumor
• Interventions: Drug: Alda-341

• Registration Number: NCT04296266
• Lead Sponsor: Stanford University

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.

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

Study Timeline

• Study Start: 2016-02
• Primary Completion: 2017-12-18
• Study Completion: 2017-12-21
• Status Verified: 2020-02
• Study First Submitted: 2020-02-20
• Study First Submitted QC: 2020-03-03
• Last Update Submitted: 2020-03-03
• Study First Posted: 2020-03-05
• Last Update Posted: 2020-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States