RQ-00000010 for Gastroparesis and Constipation in Parkinson's Disease (RQ-10)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02838797|
Recruitment Status : Completed
First Posted : July 20, 2016
Last Update Posted : October 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease Gastroparesis Constipation||Drug: RQ-00000010 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||RQ-00000010 for Gastroparesis and Constipation in Parkinson's Disease|
|Actual Study Start Date :||June 2016|
|Actual Primary Completion Date :||August 20, 2019|
|Actual Study Completion Date :||August 20, 2019|
Placebo Comparator: Placebo
For the single ascending dose study, subjects will receive a single dose of oral acetate buffer on a single day.
For the multiple ascending dose study, subjects will receive a single daily dose of oral acetate buffer each day for 14 days.
oral acetate buffer
For the single ascending dose study, subjects will receive a single dose of either:
2 micrograms, 50 micrograms or 200 micrograms of RQ-00000010 on a single day.
For the multiple ascending dose study, subjects will receive single daily doses of either 10 micrograms, 50 micrograms or 100 vs. 200 micrograms of RQ-00000010 each day for 14 days.
orally administered serotonin 4 receptor partial agonist
- Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment [ Time Frame: 18 months ]adverse events, serious adverse events, electrocardiograms, physical exams, vital signs and safety labs
- Gastric emptying [ Time Frame: 1 hour after RQ10 dosing ]Carbon 13 Breath Test kit by Cairn Diagnostics
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02838797
|United States, Virginia|
|VCU NOW Center|
|Henrico, Virginia, United States, 23233|
|Principal Investigator:||Leslie Cloud, MD, MSc||Virginia Commonwealth University|