Pill Swallow Study

A prospective, single-center, open-label, single-arm, observational study assessing participant experience with swallowing the Mock-RP

Study Overview

• Status: Completed
• Conditions: Not Determined
• Intervention / Treatment: Other: Mock-RP

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Participant age is 21 - 75 years
2. Participant understands the nature of the study, is willing to comply with protocol defined evaluations, and provide written informed consent
3. Participant currently taking injections to treat a chronic disorder
4. Non-pregnant, non-lactating female NOTE: Females who are of childbearing potential must have had a negative pregnancy test on day of screening

Exclusion Criteria:

1. Active case of COVID-19
2. History of Dysphagia
3. History of dementia (e.g., Alzheimer's, vascular dementia, dementia with Lewy bodies, etc.)
4. Participant self-reports issues with swallowing pills.
5. History of drug or alcohol abuse or any other factor that, in the Investigator's opinion, may interfere with the participant's ability to cooperate and comply with the study procedures
6. History of allergic reaction to a component of the Mock-RP
7. History which, in the investigator's judgement, makes the participant ineligible or exposes the participant to unacceptable risks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Swallow Group	Other: Mock-RP; Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent of participants successfully swallowing the Mock-RP as reported on the questionnaire.	Immediately after swallowing
Assess if participant would choose a pill instead of their current injection therapy if a pill becomes available.	Immediately after swallowing
Participant experience with swallowing Mock-RP stratified by number of years using injections.	Immediately after swallowing
Participant experience with swallowing Mock-RP stratified by age (21-50, 51-65, 66-75 years).	Immediately after swallowing
Participant experience with swallowing Mock-RP stratified by frequency of injection treatment.	Immediately after swallowing
All adverse events categorized by type and frequency.	Immediately after swallowing

Collaborators and Investigators

• Sponsor: RANI Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): August 27, 2021
• Study Completion (Actual): August 27, 2021

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: June 1, 2021
• First Posted (Actual): June 3, 2021

Study Record Updates

• Last Update Posted (Actual): September 16, 2021
• Last Update Submitted That Met QC Criteria: September 15, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CP-0003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No