Back to resultsHuman Salivary Gland Disposition of Alda-341 in Patients Undergoing Salivary Gland Surgery
Primary Purpose
Submandibular Gland Tumor, Parotid Gland Tumor
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Alda-341
Sponsored by
About this trial
This is an interventional other trial for Submandibular Gland Tumor
Eligibility Criteria
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
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Alda-341 treatment
Arm Description
Alda-341 treatment at 2 g/day for 14 days up until the day before regular medical care surgery.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04296266
Brief Title
Human Salivary Gland Disposition of Alda-341 in Patients Undergoing Salivary Gland Surgery
Official Title
Human Salivary Gland Disposition of Alda-341 in Patients Undergoing Salivary Gland Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
December 18, 2017 (Actual)
Study Completion Date
December 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
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
5. 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Submandibular Gland Tumor, Parotid Gland Tumor
7. Study Design
Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Alda-341 treatment
Arm Type
Experimental
Arm Description
Alda-341 treatment at 2 g/day for 14 days up until the day before regular medical care surgery.
Intervention Type
Drug
Intervention Name(s)
Alda-341
Other Intervention Name(s)
d-limonene
Intervention Description
Dietary supplement d-limonene orally administered as a drug.
Primary Outcome Measure Information:
Title
Bioavailability of Alda-341 in salivary gland tissue using GCMS
Description
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.
Time Frame
2 week
Secondary Outcome Measure Information:
Title
Bioavailability of Alda-341 in saliva and blood
Description
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.
Time Frame
2 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quynh-Thu Le, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Human Salivary Gland Disposition of Alda-341 in Patients Undergoing Salivary Gland Surgery
We'll reach out to this number within 24 hrs