NCT05164614

Study Evaluating PK of PTH Administered Orally Via RaniPill™ Capsule

A Phase I Study to Evaluate the Pharmacokinetics of Parathyroid Hormone (1-34) Administered Orally Via RaniPill™ Capsule

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: RANI Therapeutics · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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").

Detailed description

The RaniPill device is a capsule-like ingestible device, which injects a microneedle containing a micro tablet (payload/drug) into the intestinal wall. This is a single-center, prospective, open-label, feasibility study being conducted in two parts. Part 1: Healthy women volunteers, 18-65 years of age, of any race, recruited from the general population and assigned to one of the following groups: RT-102: * RT-102 Group 1: 20 µg (N=15) * RT-102 Group 2: 80 µg (N=15) Subcutaneous (SC): • SC Group: 20 µg of Forteo (N=10) Part 2: Healthy women, 18-65 years of age, or healthy post-menopausal or surgically sterile with bilateral oophorectomy women of any race, recruited from the general population will have once-a-day repeat dosing with 20 μg dose of RT-102 for 7 days (N= up to 12): * Healthy women: N = up to 12 * Post-menopausal or surgically sterile volunteers: N = up to 7

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-02-21
• Primary completion: 2022-10-10
• Completion: 2022-10-17
• First posted: 2021-12-20
• Last updated: 2022-10-31

Locations

1 site across 1 country: Australia