A Comparison Study of PF708 and Forteo in Healthy Subjects

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

Detailed Description
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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),

Official Title
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A Double-Masked, Randomized, Two-Treatment Cross-over Study Comparing the Pharmacokinetics of PF708 and Forteo Administered by Subcutaneous Injection in Healthy Adult Subjects

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Teriparatide


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br>Single subcutaneous injection of two teriparatide products (PF708 and Forteo) | Drug: Teriparatide<br>* Single subcutaneous injection<br>* Other names: PF708;|
| Experimental: Sequence B<br>Single subcutaneous injection of two teriparatide products (Forteo and PF708) | Drug: Teriparatide<br>* Single subcutaneous injection<br>* Other names: PF708;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum calcium concentration after a single subcutaneous dose of PF708 and Forteo |  | 0-24 hours |