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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04296266

Enrollment

Registered

2020-03-05

Start date

2016-02-29

Completion date

2017-12-21

Last updated

2020-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parotid Gland Tumor, Submandibular Gland Tumor

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

Interventions

DRUGAlda-341

Dietary supplement d-limonene orally administered as a drug.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026