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

Trial Summary

This study was performed to determine the effect of Dolcanatide on colorectal bioactivity in healthy volunteers. 27 volunteers were randomized, 25 completed the study intervention, and 24 completed the study intervention and post-intervention procedures.

Dolcanatide was administered to the volunteers in a dose of 27mg daily for 7 days.

The study concluded that mean differences in cGMP levels, before and after treatment, were similar in both arms. Dolcanatide also did not produce a pharmacodynamics (PD) response in any volunteers in the intervention arm of the trial. Dolcanatide was well tolerated amongst all randomized subjects.


Randomized trial with two arms:

  • Arms
    • Arm I: Dolcanatide 27 mg tablet daily for 7 days.
    • Arm II: Placebo tablet daily for 7 days.

Study Eligibility:
Ages Eligible for Study:18-65 Years
Sexes Eligible for Study:Male and Female
Accepts Healthy Volunteers:Yes
Inclusion and Exclusion Criteria:(see "Eligibility" tab)