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NCT03798912: RaniPill
A First-in-Human Study of the RaniPill, an Oral Drug Delivery Platform
Phase 1 trial testing RaniPill capsule containing octreotide in Healthy Volunteers in 62 participants. Completed in 17 February 2020.
17 February 2020
Quick facts
| Lead sponsor | RANI Therapeutics |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 62 |
| Start date | 9 July 2019 |
| Primary completion | 17 February 2020 |
| Estimated completion | 17 February 2020 |
| Sites | 1 location across Australia |
Drugs / interventions tested
- RaniPill capsule containing octreotide
Conditions studied
- Healthy Volunteers — all drugs for Healthy Volunteers →
Sponsor
RANI Therapeutics
Who can join
Adults 18 to 55, any sex, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this study is to ascertain the safety, tolerability and performance of the RaniPill capsule in healthy volunteers
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Foundations of gastrointestinal-based drug delivery and future developments.
Chu JN, Traverso G. · · 2022 · cited 136× · PMID 34785786 · DOI 10.1038/s41575-021-00539-w -
Development of an orally delivered GLP-1 receptor agonist through peptide engineering and drug delivery to treat chronic disease.
Pechenov S, Revell J, Will S, Naylor J, et al · · 2021 · cited 56× · PMID 34795324 · DOI 10.1038/s41598-021-01750-0 -
Oral Biologic Delivery: Advances Toward Oral Subunit, DNA, and mRNA Vaccines and the Potential for Mass Vaccination During Pandemics.
Coffey JW, Gaiha GD, Traverso G. · · 2021 · cited 41× · PMID 32466690 · DOI 10.1146/annurev-pharmtox-030320-092348 -
Barriers and Strategies for Oral Peptide and Protein Therapeutics Delivery: Update on Clinical Advances.
Baral KC, Choi KY. · · 2025 · cited 39× · PMID 40284395 · DOI 10.3390/pharmaceutics17040397
Verify or expand the search:
- PubMed search for NCT03798912
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other RANI Therapeutics trials
Trials by the same sponsor.
- NCT06891287 — An Early Phase Study of RT-114 (RaniPill Containing PG-102, a GLP-1/2 Dual Agonist) in Healthy Volunteers. · Phase 1 · recruiting
- NCT05890118 — Study Evaluating PK of Ustekinumab Administered Orally Via RaniPill™ Capsule · Phase 1 · completed
- NCT05164614 — Study Evaluating PK of PTH Administered Orally Via RaniPill™ Capsule · Phase 1 · completed
- NCT04911296 — Pill Swallow Study · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03798912 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by RANI Therapeutics
- Last refreshed: 8 October 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03798912.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing