Spots Global Cancer Trial Database for Dolcanatide in Preventing Colorectal Cancer in Healthy Volunteers

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Trial Identification

Brief Title: Dolcanatide in Preventing Colorectal Cancer in Healthy Volunteers

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

Study ID: NCT03300570

Conditions

Colorectal Carcinoma

Interventions

Dolcanatide

Laboratory Biomarker Analysis

Placebo Administration

Questionnaire Administration

Study Description

Brief 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.