NCT03300570

Dolcanatide in Preventing Colorectal Cancer in Healthy Volunteers

Phase I Double-Blind, Placebo-Controlled Trial of 27 mg Dolcanatide (SP-333) to Demonstrate Colorectal Bioactivity in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. To identify the ability of dolcanatide (SP333), when administered as a single daily dose of 27 mg x 7 days, to induce a direct pharmacological effect on cGMP levels, based on biopsy samples from the rectum obtained pre- and post-intervention, as compared to placebo. SECONDARY OBJECTIVES: I. To assess the pharmacodynamic (PD) response rate between arms (dolcanatide versus placebo). II. To confirm the safety and tolerability of dolcanatide, as compared to placebo. OUTLINE: Participants are randomized to 1 of 2 arms. ARM A: Participants receive dolcanatide orally (PO) once daily (QD) for 7 days. ARM B: Participants receive placebo PO QD for 7 days. After completion of study, participants are followed up at 21 and 51 days.

Conditions

• Colorectal Carcinoma

Interventions

Type	Name	Description
DRUG	Dolcanatide	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Placebo Administration	Given PO
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2018-07-27
• Primary completion: 2019-01-02
• Completion: 2021-05-17
• First posted: 2017-10-03
• Last updated: 2021-06-14
• Results posted: 2019-12-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study