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Pill Swallow Study

Pill Swallow Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04911296
Enrollment
150
Registered
2021-06-03
Start date
2021-06-01
Completion date
2021-08-27
Last updated
2025-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Not Determined

Brief summary

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

Interventions

OTHERMock-RP

Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating.

Sponsors

RANI Therapeutics
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Successful Swallowing of the Mock-RPImmediately after swallowingPercent of participants successfully swallowing the Mock-RP as reported on the questionnaire.
Percent of Participants Who Would Chose a Pill Instead of InjectionImmediately after swallowingAssess if a participant would choose a pill instead of their current injection therapy if a pill becomes available.
Mock-RP Swallowing ExperienceImmediately after swallowingParticipant experience with swallowing Mock-RP stratified by number of years using injections.
Adverse EventsImmediately after swallowingAll adverse events categorized by type and frequency.

Countries

United States

Participant flow

Participants by arm

ArmCount
Swallow Group
Mock-RP: Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating.
150
Total150

Baseline characteristics

CharacteristicSwallow Group
Age, Customized
21 - 50 years
50 Participants
Age, Customized
51 - 65 years
50 Participants
Age, Customized
66 - 75 years
50 Participants
BMI
21 - 50 years
35.54 kg/m^2
BMI
51 - 65 years
34.87 kg/m^2
BMI
66 - 75 years
32.93 kg/m^2
BMI
Total
34.45 kg/m^2
Race/Ethnicity, Customized
21 - 50 years
American Indian/Alaskan Native
1 Participants
Race/Ethnicity, Customized
21 - 50 years
Asian/Pacific Islander
0 Participants
Race/Ethnicity, Customized
21 - 50 years
Black - Non-Hispanic
6 Participants
Race/Ethnicity, Customized
21 - 50 years
Hispanic
32 Participants
Race/Ethnicity, Customized
21 - 50 years
White - Non-Hispanic
11 Participants
Race/Ethnicity, Customized
51 - 65 years
American Indian/Alaskan Native
1 Participants
Race/Ethnicity, Customized
51 - 65 years
Asian/Pacific Islander
0 Participants
Race/Ethnicity, Customized
51 - 65 years
Black - Non-Hispanic
5 Participants
Race/Ethnicity, Customized
51 - 65 years
Hispanic
28 Participants
Race/Ethnicity, Customized
51 - 65 years
White - Non-Hispanic
16 Participants
Race/Ethnicity, Customized
66 - 75 years
American Indian/Alaskan Native
0 Participants
Race/Ethnicity, Customized
66 - 75 years
Asian/Pacific Islander
2 Participants
Race/Ethnicity, Customized
66 - 75 years
Black - Non-Hispanic
7 Participants
Race/Ethnicity, Customized
66 - 75 years
Hispanic
24 Participants
Race/Ethnicity, Customized
66 - 75 years
White - Non-Hispanic
17 Participants
Race/Ethnicity, Customized
Total
American Indian/Alaskan Native
2 Participants
Race/Ethnicity, Customized
Total
Asian/Pacific Islander
2 Participants
Race/Ethnicity, Customized
Total
Black - Non-Hispanic
18 Participants
Race/Ethnicity, Customized
Total
Hispanic
84 Participants
Race/Ethnicity, Customized
Total
White - Non-Hispanic
44 Participants
Region of Enrollment
Australia
150 Participants
Sex: Female, Male
21 - 50 years
Female
29 Participants
Sex: Female, Male
21 - 50 years
Male
21 Participants
Sex: Female, Male
51 - 65 years
Female
28 Participants
Sex: Female, Male
51 - 65 years
Male
22 Participants
Sex: Female, Male
66 - 75 years
Female
28 Participants
Sex: Female, Male
66 - 75 years
Male
22 Participants
Sex: Female, Male
Total
Female
85 Participants
Sex: Female, Male
Total
Male
65 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 150
other
Total, other adverse events
0 / 150
serious
Total, serious adverse events
0 / 150

Outcome results

Primary

Adverse Events

All adverse events categorized by type and frequency.

Time frame: Immediately after swallowing

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Swallow GroupAdverse Events0 Participants
Primary

Mock-RP Swallowing Experience

Participant experience with swallowing Mock-RP stratified by number of years using injections.

Time frame: Immediately after swallowing

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Swallow GroupMock-RP Swallowing ExperienceEasy12 Participants
Swallow GroupMock-RP Swallowing ExperienceLarge Pill - Easy3 Participants
Swallow GroupMock-RP Swallowing ExperienceChallenging Due to Size1 Participants
Swallow GroupMock-RP Swallowing ExperienceNo Comment0 Participants
1-5 YearsMock-RP Swallowing ExperienceNo Comment2 Participants
1-5 YearsMock-RP Swallowing ExperienceEasy46 Participants
1-5 YearsMock-RP Swallowing ExperienceChallenging Due to Size3 Participants
1-5 YearsMock-RP Swallowing ExperienceLarge Pill - Easy8 Participants
>5 YearsMock-RP Swallowing ExperienceNo Comment1 Participants
>5 YearsMock-RP Swallowing ExperienceLarge Pill - Easy14 Participants
>5 YearsMock-RP Swallowing ExperienceChallenging Due to Size4 Participants
>5 YearsMock-RP Swallowing ExperienceEasy56 Participants
p-value: 0.935Fisher Exact
Primary

Mock-RP Swallowing Experience

Participants' experience with swallowing Mock-RP was stratified by age (21-50, 51-65, 66-75 years).

Time frame: Immediately after swallowing

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Swallow GroupMock-RP Swallowing ExperienceEasy36 Participants
Swallow GroupMock-RP Swallowing ExperienceLarge Pill - Easy10 Participants
Swallow GroupMock-RP Swallowing ExperienceChallenging Due to Size4 Participants
Swallow GroupMock-RP Swallowing ExperienceNo Comment0 Participants
1-5 YearsMock-RP Swallowing ExperienceNo Comment1 Participants
1-5 YearsMock-RP Swallowing ExperienceEasy37 Participants
1-5 YearsMock-RP Swallowing ExperienceChallenging Due to Size3 Participants
1-5 YearsMock-RP Swallowing ExperienceLarge Pill - Easy9 Participants
>5 YearsMock-RP Swallowing ExperienceNo Comment2 Participants
>5 YearsMock-RP Swallowing ExperienceLarge Pill - Easy6 Participants
>5 YearsMock-RP Swallowing ExperienceChallenging Due to Size1 Participants
>5 YearsMock-RP Swallowing ExperienceEasy41 Participants
p-value: 0.536Fisher Exact
Primary

Mock-RP Swallowing Experience

Participants completed a questionnaire after swallowing the Mock-RP stating if they would select a pill alternative over their current injections - stratified by frequency of injection treatment.

Time frame: Immediately after swallowing

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Swallow GroupMock-RP Swallowing ExperienceYes92 Participants
Swallow GroupMock-RP Swallowing ExperienceNo10 Participants
1-5 YearsMock-RP Swallowing ExperienceYes2 Participants
1-5 YearsMock-RP Swallowing ExperienceNo0 Participants
>5 YearsMock-RP Swallowing ExperienceNo2 Participants
>5 YearsMock-RP Swallowing ExperienceYes34 Participants
MonthlyMock-RP Swallowing ExperienceYes8 Participants
MonthlyMock-RP Swallowing ExperienceNo2 Participants
Primary

Percent of Participants Who Would Chose a Pill Instead of Injection

Assess if a participant would choose a pill instead of their current injection therapy if a pill becomes available.

Time frame: Immediately after swallowing

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Swallow GroupPercent of Participants Who Would Chose a Pill Instead of Injection136 Participants
Primary

Successful Swallowing of the Mock-RP

Percent of participants successfully swallowing the Mock-RP as reported on the questionnaire.

Time frame: Immediately after swallowing

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Swallow GroupSuccessful Swallowing of the Mock-RP150 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026