Healthy VolunteersPhase 1RaniPillNCT03798912
A First-in-Human Study of the RaniPill, an Oral Drug Delivery Platform
A Phase 1 study testing RaniPill capsule containing octreotide in people with Healthy Volunteers, run by RANI Therapeutics at 1 site in Australia.
Trial summary
The objective of this study is to ascertain the safety, tolerability and performance of the RaniPill capsule in healthy volunteers Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- RaniPill capsule containing octreotide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Jul 2019to 17 Feb 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study of the Safety and Pharmacokinetics of Single Doses of Octreotide Administered Orally Via the RaniPill™ Capsule in Healthy Subjects
The objective of this study is to ascertain the safety, tolerability and performance of the RaniPill capsule in healthy volunteers
Read the detailed description
The RaniPill device is capsule-like ingestible device, which injects a microneedle containing a microtablet (payload/drug) into the intestinal wall. This is a phase I (first-in-human) open-label study in healthy volunteers. In 6 subjects, 100 mcg of octreotide (Sandostatin®) will be injected intravenously. Three versions of the RaniPill (A, B and C) will be tested in additional three groups of healthy volunteers (N=20 each). All devices will contain 100 mcg of octreotide. The bioavailability of octreotide will be determined by serial blood sampling in Groups A and B. Performance of the RaniPill will be evaluated in all groups.
- Conditions
- Healthy Volunteers
- Being tested
- RaniPill capsule containing octreotide
- Keywords
- RaniPill capsule, drug delivery, octreotide, pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaniPill capsule containing octreotideCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous octreotide group | Active comparator | Octreotide 100 mcg will be injected intravenously and serial blood samples will be collected for PK analysis Receives: Combination Product: RaniPill capsule containing octreotide |
| RaniPill A group | Experimental | In 20 subjects, a RaniPill with a small balloon size will be administered and serial blood samples will be collected for PK analysis Receives: Combination Product: RaniPill capsule containing octreotide |
| RaniPill B group | Experimental | In 20 subjects, a RaniPill with a larger balloon size will be administered and serial blood samples will be collected for PK analysis Receives: Combination Product: RaniPill capsule containing octreotide |
| RaniPill C group | Experimental | In 20 subjects, a RaniPill with a different size will be administered and blood samples will be collected for the presence of drug Receives: Combination Product: RaniPill capsule containing octreotide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and kind of adverse events possibly related to the RaniPill capsule
All adverse events possibly related to the device, including abdominal pain, nausea and vomiting, injuries to the gastrointestinal tract and abnormal changes in blood tests results will be monitored and recorded
Measured: Up to 30 days after ingestion of the device
Secondary outcomes (2)
Pharmacokinetic profile of octreotide delivered by the RaniPill capsule
Measurements of octreotide concentration in plasma samples collected serially over 4 h following the deployment of the RaniPill
Measured: 4 to 8 hours
Confirmation of the excretion of all RaniPill device components
Stool examinations to verify that all components of the RaniPill capsule have been defecated
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start9 Jul 2019
- Primary completion17 Feb 2020
- Study completion17 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Healthy men and women volunteers
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- RANI Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arvinder K Dhalla, PhD, Study director, RANI Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798912
- Sponsor's protocol ID
- TST-0114
- Acronym
- RaniPill
- Status last verified
- Oct 2020
- First submitted
- 13 Dec 2018
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of the Safety and Pharmacokinetics of Single Doses of Octreotide Administered Orally Via the RaniPill™ Capsule in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03798912
- Acronym / sponsor ID
- RaniPill / TST-0114
- Conditions
- Healthy Volunteers
- Keywords
- RaniPill capsule, drug delivery, octreotide, pharmacokinetic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- RANI TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 17 Feb 2020 (actual)
- First posted
- 10 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to ascertain the safety, tolerability and performance of the RaniPill capsule in healthy volunteers
Detailed description
The RaniPill device is capsule-like ingestible device, which injects a microneedle containing a microtablet (payload/drug) into the intestinal wall. This is a phase I (first-in-human) open-label study in healthy volunteers. In 6 subjects, 100 mcg of octreotide (Sandostatin®) will be injected intravenously. Three versions of the RaniPill (A, B and C) will be tested in additional three groups of healthy volunteers (N=20 each). All devices will contain 100 mcg of octreotide. The bioavailability of octreotide will be determined by serial blood sampling in Groups A and B. Performance of the RaniPill will be evaluated in all groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Healthy men and women volunteers
| Arm | Type | Receives |
|---|---|---|
| Intravenous octreotide group | Active comparator | Combination Product: RaniPill capsule containing octreotideOctreotide 100 mcg will be injected intravenously and serial blood samples will be collected for PK analysis |
| RaniPill A group | Experimental | Combination Product: RaniPill capsule containing octreotideIn 20 subjects, a RaniPill with a small balloon size will be administered and serial blood samples will be collected for PK analysis |
| RaniPill B group | Experimental | Combination Product: RaniPill capsule containing octreotideIn 20 subjects, a RaniPill with a larger balloon size will be administered and serial blood samples will be collected for PK analysis |
| RaniPill C group | Experimental | Combination Product: RaniPill capsule containing octreotideIn 20 subjects, a RaniPill with a different size will be administered and blood samples will be collected for the presence of drug |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RaniPill capsule containing octreotideAdministration 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. | Combination product | Intravenous octreotide group, RaniPill A group, RaniPill B group, RaniPill C group |
Primary outcome
Incidence and kind of adverse events possibly related to the RaniPill capsule
Time frame: Up to 30 days after ingestion of the device
All adverse events possibly related to the device, including abdominal pain, nausea and vomiting, injuries to the gastrointestinal tract and abnormal changes in blood tests results will be monitored and recorded
2 secondary outcomes
Pharmacokinetic profile of octreotide delivered by the RaniPill capsule
Time frame: 4 to 8 hours
Confirmation of the excretion of all RaniPill device components
Time frame: up to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: No
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Screening Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arvinder K Dhalla, PhD study director
RANI Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RaniPill capsule containing octreotide in people with Healthy Volunteers, run by RANI Therapeutics at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and kind of adverse events possibly related to the RaniPill capsule (time frame: Up to 30 days after ingestion of the device). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.