Effect of Octreotide on Saliva

NCT05340192 | Completed Phase 1 FDA Drug

• 1 other identifier: Pro00100579
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the effect of Octreotide on saliva enzymes. The study team hypothesizes that Octreotide will decrease the levels of certain proteins, specifically the metalloproteinase family.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• To quantify the change of saliva proteomes of subjects pre-octreotide treatment

  Saliva samples analyzed using quantitative LC/MS/MS using a nanAcquity UPLC system (Waters Corp) coupled to a Thermo Orbitrap Fusion Lumos high resolution accurate mass tandem mass spectrometer (Thermo) via a nanoelectrospray ionization source

  Day 1 pre-treatment

• To quantify the change of saliva proteomes of subjects post-octreotide treatment

  Saliva samples analyzed using quantitative LC/MS/MS using a nanAcquity UPLC system (Waters Corp) coupled to a Thermo Orbitrap Fusion Lumos high resolution accurate mass tandem mass spectrometer (Thermo) via a nanoelectrospray ionization source

  Day 1 post-treatment

Study Arms (1)

Healthy Volunteer

OTHER

Octreotide, 100 mcg (1 ml) s.c.

Drug: Octreotide 1 MG/ML

Interventions

Octreotide 1 MG/ML DRUG

100 mcg (1 ml) of Octreotide

Healthy Volunteer

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults between the ages of 18-40 years old
• Healthy volunteer who is willing to undergo research activities
• Healthy volunteer with no self-report of disease, oral symptoms or lesions, or cold or flu like symptoms that would affect the reflective measurements in the oral cavity
• Ability to understand and the willingness to sign a written informed consent document

You may not qualify if:

• Pregnant or nursing women
• Children under the age of 18 or adults over 40
• Complaint of oral symptoms (self-reported)
• Medical condition affecting saliva (e.g. Sjogren's)
• History of head/neck radiation
• Medication that might affect saliva (e.g. Proton Pump Inhibitors)
• Known allergy to Octreotide
• Non-English speaking
• Diabetes, gallbladder disease, heart disease, high blood pressure, a heart rhythm disorder, thyroid problems, pancreatitis, kidney disease, or liver disease (self-reported)

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Interventions

Octreotide

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Walter Lee, MD, MHS

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a healthy volunteer pilot study. Subjects will be asked to provide a saliva sample after a 2 hour fast and 5 minutes after rinsing their mouth with tap water. The sample will be collected in an Eppendorf vial. After providing the saliva sample, each subject will be injected subcutaneously with 100 mcg (1 ml) of Octreotide by either a physician or registered nurse. A second sample of saliva will be collected using the same protocol 45-55 minutes after administering the drug.

Study Record Dates

• First Submitted: April 15, 2022
• First Posted: April 22, 2022
• Study Start: September 24, 2019
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)