A Comparison Study of PF708 and Forteo in Healthy Subjects

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02656810

Enrollment

Registered

2016-01-15

Start date

2015-12-31

Completion date

2016-07-31

Last updated

2016-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

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),

Interventions

DRUGTeriparatide

Single subcutaneous injection

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026