MedTrace Logo

A First-in-Human Study of the RaniPill, an Oral Drug Delivery Platform

NCT03798912 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2020-10-08

No results posted yet for this study

Summary

The objective of this study is to ascertain the safety, tolerability and performance of the RaniPill capsule in healthy volunteers

Conditions

  • Healthy Volunteers

Interventions

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.

Sponsors & Collaborators

  • RANI Therapeutics

    lead INDUSTRY

Principal Investigators

  • Arvinder K Dhalla, PhD · RANI Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-09
Primary Completion
2020-02-17
Completion
2020-02-17
FDA Device
Yes

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03798912 on ClinicalTrials.gov