A Comparison Study of PF708 and Forteo in Healthy Subjects

Phase 1

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Teriparatide

• Registration Number: NCT02656810
• Lead Sponsor: Pfenex, Inc

Brief Summary

The purpose of this study is to compare the pharmacokinetics (blood levels) of two teriparatide products, PF708 and Forteo, in healthy subjects.

Detailed Description

This is a double-masked, randomized, two-treatment cross-over study in healthy adult subjects. Half of the subjects will be randomized to receive PF708 first and Forteo second (Sequence A), and the other half will be randomized to receive the drugs in reverse sequence (Sequence B),

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-12
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-15
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-02
• Last Update Posted: 2016-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Male or female aged 18-50 years at the time of Informed Consent.
• Able to understand and sign the written Informed Consent Form (ICF).

Exclusion Criteria

• History of or positive test result for human immunodeficiency virus (HIV), hepatitis C virus [test for hepatitis C virus antibody (HCV Ab)] or hepatitis B virus [test for hepatitis B surface antigen (HBsAg)].
• Female subjects who are pregnant or have a positive pregnancy test result, currently breastfeeding, or planning to become pregnant during the course of the study.
• Blood donation (greater than or equal to 500 mL) within 30 days prior to screening.
• History of Paget's disease of bone.
• History of prior external beam or implant radiation therapy involving the skeleton.
• Active urolithiasis or primary hyperparathyroidism.
• History of alcohol or substance abuse within 3 years prior to screening.
• Previous treatment, including for investigational purposes, with any products (e.g., Forteo, Natpara) derived from human parathyroid hormone (PTH).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence A	Teriparatide	Single subcutaneous injection of two teriparatide products (PF708 and Forteo)
Sequence B	Teriparatide	Single subcutaneous injection of two teriparatide products (Forteo and PF708)

Primary Outcome Measures

Name	Time	Method
Serum area-under-the-curve (AUC) of PF708 and Forteo	24 hours
Serum maximum concentration (Cmax) of PF708 and Forteo	24 hours

Secondary Outcome Measures

Name	Time	Method
Change in serum calcium concentration after a single subcutaneous dose of PF708 and Forteo	0-24 hours

Trial Locations

Locations (1)

Covance Clinical Research Unit; 🇺🇸 Evansville, Indiana, United States