This is a study to determine the safety and tolerability of a new medicine (RQ10) for gastrointestinal symptoms in Parkinson's disease. The investigators will also begin to look at the effect of this medicine on gastrointestinal problems. The results will determine if future studies are appropriate. In this study, RQ10 will be compared to a placebo (a look-alike inactive substance). Participation will include multiple office visits. Approximately 48 people will participate.
This is a phase Ib study with the primary objectives of determining the safety and tolerability as well as pharmacokinetics after single ascending doses (SAD) and multiple ascending doses (MAD) of RQ10 in Parkinson's disease patients. A secondary objective will be to assess the impact of single doses of RQ10 on gastric emptying in Parkinson's Disease patients as well as the effects of RQ10 on gastroparesis symptoms. The expected results of this exploratory phase Ib study will allow deciding about whether to proceed with further development of RQ10 in Parkinson's Disease patients ("go-no go") and help design a formal phase IIa "proof of concept" study by informing repeat-dose selection and possible effect sizes in Parkinson's Disease patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
51
orally administered serotonin 4 receptor partial agonist
oral acetate buffer
VCU NOW Center
Henrico, Virginia, United States
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
adverse events, serious adverse events, electrocardiograms, physical exams, vital signs and safety labs
Time frame: 18 months
Gastric emptying
Carbon 13 Breath Test kit by Cairn Diagnostics
Time frame: 1 hour after RQ10 dosing
Area Under the Curve [AUC] for RQ-00000010 after single and multiple doses
Time frame: 18 months
Peak Plasma Concentration (Cmax) for RQ-00000010 after single and multiple doses
Time frame: 18 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.