A Comparison Study of PF708 and Forteo in Healthy Subjects

August 2, 2016 updated by: Pfenex, Inc

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Indiana
      • Evansville, Indiana, United States, 47710
        • Covance Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence A
Single subcutaneous injection of two teriparatide products (PF708 and Forteo)
Drug: Teriparatide
Single subcutaneous injection
Other Names:
  • PF708
Experimental: Sequence B
Single subcutaneous injection of two teriparatide products (Forteo and PF708)
Drug: Teriparatide
Single subcutaneous injection
Other Names:
  • PF708

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum area-under-the-curve (AUC) of PF708 and Forteo
Time Frame: 24 hours
24 hours
Serum maximum concentration (Cmax) of PF708 and Forteo
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfenex, Inc

Investigators

  • Study Director: Hubert C Chen, M.D., Pfenex, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

January 12, 2016

First Submitted That Met QC Criteria

January 14, 2016

First Posted (Estimate)

January 15, 2016

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PF708-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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