Clinical trial NCT03798912: A First-in-Human Study of the RaniPill, an Oral Drug Delivery Platform
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: RaniPill capsule, drug delivery, octreotide, pharmacokinetic
Lead sponsor: RANI Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-01-10
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Healthy men and women volunteers
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Incidence and kind of adverse events possibly related to the RaniPill capsule
timeFrame: Up to 30 days after ingestion of the device
Secondary outcomes:
measure: Pharmacokinetic profile of octreotide delivered by the RaniPill capsule
timeFrame: 4 to 8 hours
measure: Confirmation of the excretion of all RaniPill device components
timeFrame: up to 7 days
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network
Study officials:
affiliation: RANI Therapeutics
name: Arvinder K Dhalla, PhD
role: STUDY_DIRECTOR
References: