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

NCT02838797 | Completed Phase 1 DMC

• 1 other identifier: HM20001657
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease; Gastroparesis; Constipation

Keywords

Parkinson's disease; Gastroparesis; Constipation; Prokinetic; 5-HT4-receptor partial agonist

Outcome Measures

Primary Outcomes (1)

• 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

  18 months

Secondary Outcomes (3)

• Gastric emptying

  1 hour after RQ10 dosing

• Area Under the Curve [AUC] for RQ-00000010 after single and multiple doses

  18 months

• Peak Plasma Concentration (Cmax) for RQ-00000010 after single and multiple doses

  18 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Drug: Placebo

RQ-00000010

EXPERIMENTAL

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.

Drug: RQ-00000010

Interventions

RQ-00000010 DRUG

orally administered serotonin 4 receptor partial agonist

RQ-00000010

Placebo DRUG

oral acetate buffer

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Michael J. Fox Foundation for Parkinson's Research: collaborator
• RaQualia Pharma Inc.: collaborator

Study Sites (1)

VCU NOW Center

Henrico, Virginia, 23233, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Gastroparesis; Constipation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Leslie Cloud, MD, MSc

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2016
• First Posted: July 20, 2016
• Study Start: June 1, 2016
• Primary Completion: August 20, 2019
• Study Completion: August 20, 2019
• Last Updated: October 9, 2019

Record last verified: 2019-10

Locations

US (1)