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
1 other identifier
interventional
70
1 country
1
Brief Summary
The purpose of this study is to compare the pharmacokinetics (blood levels) of two teriparatide products, PF708 and Forteo, in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2015
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 12, 2016
CompletedFirst Posted
Study publicly available on registry
January 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedAugust 4, 2016
August 1, 2016
7 months
January 12, 2016
August 2, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Serum area-under-the-curve (AUC) of PF708 and Forteo
24 hours
Serum maximum concentration (Cmax) of PF708 and Forteo
24 hours
Secondary Outcomes (1)
Change in serum calcium concentration after a single subcutaneous dose of PF708 and Forteo
0-24 hours
Study Arms (2)
Sequence A
EXPERIMENTALSingle subcutaneous injection of two teriparatide products (PF708 and Forteo)
Sequence B
EXPERIMENTALSingle subcutaneous injection of two teriparatide products (Forteo and PF708)
Interventions
Eligibility Criteria
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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfenex, Inclead
Study Sites (1)
Covance Clinical Research Unit
Evansville, Indiana, 47710, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hubert C Chen, M.D.
Pfenex, Inc
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2016
First Posted
January 15, 2016
Study Start
December 1, 2015
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
August 4, 2016
Record last verified: 2016-08