RQ-00000010 for Gastroparesis and Constipation in Parkinson’s Disease

Study Rationale:                   
Constipation and gastroparesis (slow stomach emptying) are common non-motor symptoms of Parkinson’s disease (PD). These symptoms cause troublesome gastrointestinal issues and can impair the absorption of and, response to, Parkinson’s medications, such as levodopa. Unfortunately, there are FDA-approved treatments for slow stomach emptying in PD, and rigorously tested treatments for constipation in PD are scarce. In this trial, we will test the safety and tolerability of RQ-00000010, a compound owned by Raqualia Pharma, Inc., that may help treat slow stomach emptying and constipation, thereby addressing two important, unmet clinical needs in PD.

Hypothesis:
Our primary goals are to assess the safety and tolerability of RQ-00000010 in individuals with Parkinson’s disease, determine the best dose(s) for future studies and examine at the effects of RQ-00000010 on stomach emptying and constipation. 

Study Design:
This is a randomized, double-blind, placebo-controlled trial of single- and multiple-ascending doses of RQ-00000010.

Impact on Diagnosis/Treatment of Parkinson’s Disease:              
If RQ-00000010 is safe, well-tolerated and effective, it may be used to treat the symptoms of slow stomach emptying and constipation in PD. It may also improve the effectiveness of levodopa. 

Next Steps for Development:
If successful, this study will help support larger phase II studies of RQ-00000010, which will further assess the safety and efficacy of this compound in Parkinson’s.

Trial Phase: I