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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03798912




Registration number
NCT03798912
Ethics application status
Date submitted
13/12/2018
Date registered
10/01/2019
Date last updated
8/10/2020

Titles & IDs
Public title
A First-in-Human Study of the RaniPill, an Oral Drug Delivery Platform
Scientific title
A Phase 1 Study of the Safety and Pharmacokinetics of Single Doses of Octreotide Administered Orally Via the RaniPill™ Capsule in Healthy Subjects
Secondary ID [1] 0 0
TST-0114
Universal Trial Number (UTN)
Trial acronym
RaniPill
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Combination Product - RaniPill capsule containing octreotide

Active Comparator: Intravenous octreotide group - Octreotide 100 mcg will be injected intravenously and serial blood samples will be collected for PK analysis

Experimental: RaniPill A group - In 20 subjects, a RaniPill with a small balloon size will be administered and serial blood samples will be collected for PK analysis

Experimental: RaniPill B group - In 20 subjects, a RaniPill with a larger balloon size will be administered and serial blood samples will be collected for PK analysis

Experimental: RaniPill C group - In 20 subjects, a RaniPill with a different size will be administered and blood samples will be collected for the presence of drug


Combination Product: RaniPill capsule containing octreotide
Administration of a RaniPill capsule loaded with 100 mcg of octreotide. Serial blood samples will be collected over the following 4 h for pharmacokinetic analysis of octreotide a) injected intravenously and b) delivered directly into the jejunal wall by the RaniPill capsule.
Intervention code [1] 0 0
Combination Product
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence and kind of adverse events possibly related to the RaniPill capsule
Timepoint [1] 0 0
Up to 30 days after ingestion of the device
Secondary outcome [1] 0 0
Pharmacokinetic profile of octreotide delivered by the RaniPill capsule
Timepoint [1] 0 0
4 to 8 hours
Secondary outcome [2] 0 0
Confirmation of the excretion of all RaniPill device components
Timepoint [2] 0 0
up to 7 days

Eligibility
Key inclusion criteria
- Signed and dated informed consent form

- Willing to comply with all study procedures and available for the entire duration of
the study

- Age between 18 and 55 years

- BMI 17 - 32 kg/m2

- In good general health confirmed by medical history, physical examination, and absence
of clinically important laboratory abnormalities per investigator's judgment;

- Women of reproductive potential must use, between study day and the final study visit,
a highly effective contraceptive, as defined in the Informed Consent Document, and
have a negative urine pregnancy test at the time of screening, as well as on the day
of study.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Unable to swallow an intact 000 capsule with water

- History of gastrointestinal surgery or illness, including diarrhea, constipation or
other manifestations suggestive of abnormal digestion

- Use of an antacid, proton pump inhibitor or histamine H2 receptor antagonist within 5
days of study day

- Barium ingestion within 30 days of study day

- Allergy or sensitivity to contrast media, iodine, barium sulfate, or latex

- History chronic disease other than mild to moderate systemic hypertension

- Menstruation on day of dosing

- Pregnancy or lactating state

- Participation in an investigational or marketed drug trial within 30 days of the
screening visit

- Low likelihood, in the investigator's judgment, to complete the study as required per
study plan;

- Any other history which, in the investigator's judgment, makes the subject ineligible
or exposes the subject to a risk;

- History of allergic reactions to a component of the RaniPill device or any allergic
history other than common food (i.e. shellfish) or insect (i.e. bees) allergies;

- Febrile illness within 5 days;

- History of drug or alcohol abuse or any other factor that, in the investigator's
opinion, may interfere with the subject's ability to cooperate and comply with the
study procedures.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/07/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/02/2020
Sample size
Target
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
RANI Therapeutics
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective of this study is to ascertain the safety, tolerability and performance of the
RaniPill capsule in healthy volunteers
Trial website
https://clinicaltrials.gov/ct2/show/NCT03798912
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Arvinder K Dhalla, PhD
Address 0 0
RANI Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03798912