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Dolcanatide in Preventing Colorectal Cancer in Healthy Volunteers

NCT03300570 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2021-06-14

Study results available
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Summary

This phase I trial studies how well dolcanatide works in preventing colorectal cancer in healthy participants. Dolcanatide is similar to a natural hormone released into the intestine. It is thought that people who have low levels of the hormone are more likely to get colon cancer. It may be possible to prevent colon cancer by giving a drug that is similar to the hormone, such as dolcanatide.

Conditions

  • Colorectal Carcinoma

Interventions

DRUG

Dolcanatide

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Placebo Administration

Given PO

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • David S Weinberg · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-27
Primary Completion
2019-01-02
Completion
2021-05-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03300570 on ClinicalTrials.gov