Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
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.
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
