A Comparison Study of PF708 and Forteo in Healthy Subjects

Completed · Phase 1

Conditions studied: Osteoporosis

In brief

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

Key facts

Study ID

NCT02656810

Run by

Pfenex, Inc

People needed

70

Starts

2015-12-01

Expected to finish

2016-07-01

Last updated by the study team

2016-08-04

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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).

Where it is running

• Covance Clinical Research Unit — Evansville, Indiana, United States

Full record on ClinicalTrials.gov

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