A Comparison Study of PF708 and Forteo in Healthy Subjects

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02656810
• Other study ID #: PF708-101
• Status: Completed
• Phase: Phase 1
• First received: January 12, 2016
• Last updated: August 2, 2016
• Start date: December 2015
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Pfenex, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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),

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Teriparatide
Single subcutaneous injection

Locations

Country	Name	City	State
United States	Covance Clinical Research Unit	Evansville	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Pfenex, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum area-under-the-curve (AUC) of PF708 and Forteo		24 hours	No
Primary	Serum maximum concentration (Cmax) of PF708 and Forteo		24 hours	No
Secondary	Change in serum calcium concentration after a single subcutaneous dose of PF708 and Forteo		0-24 hours	No