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Study Evaluating PK of PTH Administered Orally Via RaniPill™ Capsule

NCT05164614 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-10-31

No results posted yet for this study

Summary

A prospective, single-center, open-label, phase I study evaluating the pharmacokinetics (PK) of human parathyroid hormone (1-34) ("PTH") administered via the RaniPill™ capsule ("RT-102").

Conditions

  • Healthy Volunteers

Interventions

COMBINATION_PRODUCT

RT-102 (80 μg)

RaniPill capsule containing PTH with doses of 20 and 80 μg

DRUG

Forteo

A commercial formulation of PTH for SC control (20 µg)

COMBINATION_PRODUCT

RT-102 (20 μg)

RaniPill capsule containing PTH with dose of 20μg

Sponsors & Collaborators

  • RANI Therapeutics

    lead INDUSTRY

Principal Investigators

  • Joshua Myers · RANI Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-21
Primary Completion
2022-10-10
Completion
2022-10-17

Countries

  • Australia

Study Locations

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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 NCT05164614 on ClinicalTrials.gov