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

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04296266
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 22.6
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Submandibular Gland Tumor; Parotid Gland Tumor	Drug: Alda-341	Early Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Human Salivary Gland Disposition of Alda-341 in Patients Undergoing Salivary Gland Surgery
• Actual Study Start Date: Feb 1, 2016
• Actual Primary Completion Date: Dec 18, 2017
• Actual Study Completion Date: Dec 21, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Alda-341 treatment Alda-341 treatment at 2 g/day for 14 days up until the day before regular medical care surgery.	Drug: Alda-341; Dietary supplement d-limonene orally administered as a drug.; Other Names: d-limonene

Outcome Measures

Primary Outcome Measures

1. 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

1. 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 Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Stanford	California	United States	94304

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Quynh-Thu Le, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT04296266
• Other Study ID Numbers: IRB-32994
• First Posted: Mar 5, 2020
• Last Update Posted: Mar 5, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Parotid Neoplasms; Submandibular Gland Neoplasms

Study Results

No Results Posted as of Mar 5, 2020