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

Parotid Gland Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04296266
• Other study ID #: IRB-32994
• Status: Completed
• Phase: Early Phase 1
• Start date: February 2016
• Est. completion date: December 21, 2017

Study information

• Verified date: February 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 21, 2017
• Est. primary completion date: December 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parotid Gland Tumor
• Parotid Neoplasms
• Submandibular Gland Tumor

Intervention

Drug:
• Alda-341
Dietary supplement d-limonene orally administered as a drug.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Bioavailability of Alda-341 in saliva and blood	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.	2 week