Back to resultsA Comparison Study of PF708 and Forteo in Healthy Subjects
Primary Purpose
Osteoporosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Teriparatide
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis
Eligibility Criteria
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).
Sites / Locations
- Covance Clinical Research Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Sequence A
Sequence B
Arm Description
Single subcutaneous injection of two teriparatide products (PF708 and Forteo)
Single subcutaneous injection of two teriparatide products (Forteo and PF708)
Outcomes
Primary Outcome Measures
Serum area-under-the-curve (AUC) of PF708 and Forteo
Serum maximum concentration (Cmax) of PF708 and Forteo
Secondary Outcome Measures
Change in serum calcium concentration after a single subcutaneous dose of PF708 and Forteo
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02656810
Brief Title
A Comparison Study of PF708 and Forteo in Healthy Subjects
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfenex, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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),
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sequence A
Arm Type
Experimental
Arm Description
Single subcutaneous injection of two teriparatide products (PF708 and Forteo)
Arm Title
Sequence B
Arm Type
Experimental
Arm Description
Single subcutaneous injection of two teriparatide products (Forteo and PF708)
Intervention Type
Drug
Intervention Name(s)
Teriparatide
Other Intervention Name(s)
PF708
Intervention Description
Single subcutaneous injection
Primary Outcome Measure Information:
Title
Serum area-under-the-curve (AUC) of PF708 and Forteo
Time Frame
24 hours
Title
Serum maximum concentration (Cmax) of PF708 and Forteo
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Change in serum calcium concentration after a single subcutaneous dose of PF708 and Forteo
Time Frame
0-24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hubert C Chen, M.D.
Organizational Affiliation
Pfenex, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Covance Clinical Research Unit
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Comparison Study of PF708 and Forteo in Healthy Subjects
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