NCT05137730

A Study of Relative Bioavailability of a New Formulation Compared With the Approved Formulation of rhPTH [1-84] and to Find Out Dose Linearity of the New Formulation in Healthy Adults

A Randomized, Open-label, Single-center, Single-dose Study to Evaluate the Relative Bioavailability of a New Formulation Compared With the Approved Formulation of Recombinant Human Parathyroid Hormone (rhPTH[1-84]) and to Assess Dose Linearity of the New Formulation in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The main aim of Part I of this study is to evaluate the relative bioavailability of a new formulation compared with the approved formulation when a single dose of rhPTH(1-84) is given to healthy volunteers. Bioavailability is the ability of a drug to be absorbed and used by the body. In Part II, the main aim is to assess the dose linearity of the new formulation. Participants will receive 2 doses in Part I and 4 doses in Part II. Participants need to visit their doctor approximately 14 days and 30 days after the last dose of study drug.

Detailed description

This study will be conducted in two parts (Part I and Part II). Part I consists of two treatment periods with 2 sequences and part II consists of four treatment periods with 4 sequences. In Part I, relative bioavailability of Formulation A (Test: 100 microgram \[mcg\] rhPTH\[1-84\]) will be compared with Formulation B (Reference: 100 mcg rhPTH\[1-84\]). In Part II, dose linearity of the new formulation, Formulation A, of rhPTH (1-84) will be assessed based on 4 different dose levels as dose c - f (dose c = 25 mcg, dose d = 50 mcg, dose e = 75 mcg and f = 200 mcg). Both parts may be conducted concurrently.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	rhPTH(1-84)	Participants in both part I and part II of the study will receive a single SC injection of rhPTH(1-84) depending upon the treatment sequence allocation on Day 1 of each treatment period.

Timeline

• Start date: 2021-11-29
• Primary completion: 2022-04-15
• Completion: 2022-04-15
• First posted: 2021-11-30
• Last updated: 2023-12-15
• Results posted: 2023-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study