NCT03150108

Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult Subjects

A Phase 1, Open-label, Randomized, Cross-over Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Single Dose of rhPTH(1-84) Administered Subcutaneously in Japanese Healthy Subjects Compared With Matched Non-Hispanic, Caucasian Healthy Adult Subjects and to Assess Dose Proportionality of 3 Doses of rhPTH(1-84) in the Japanese Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare how rhPTH(1-84) affects the body between healthy adults of Japanese descent and matched, healthy Caucasian adults.

Conditions

• Hypoparathyroidism

Interventions

Type	Name	Description
DRUG	rhPTH(1-84)	25 mcg rhPTH(1-84) SC injection
DRUG	rhPTH(1-84)	50 mcg rhPTH(1-84) SC injection
DRUG	rhPTH(1-84)	100 mcg rhPTH(1-84) SC injection

Timeline

• Start date: 2017-05-16
• Primary completion: 2017-06-26
• Completion: 2017-06-26
• First posted: 2017-05-12
• Last updated: 2021-06-08
• Results posted: 2019-07-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study