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A Comparison Study of PF708 and Forteo in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02656810
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : August 4, 2016
Sponsor:
Information provided by (Responsible Party):
Pfenex, Inc

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

Condition or disease Intervention/treatment Phase
Osteoporosis Drug: Teriparatide Phase 1

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),

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sequence A
Single subcutaneous injection of two teriparatide products (PF708 and Forteo)
Drug: Teriparatide
Single subcutaneous injection
Other Name: PF708

Experimental: Sequence B
Single subcutaneous injection of two teriparatide products (Forteo and PF708)
Drug: Teriparatide
Single subcutaneous injection
Other Name: PF708




Primary Outcome Measures :
  1. Serum area-under-the-curve (AUC) of PF708 and Forteo [ Time Frame: 24 hours ]
  2. Serum maximum concentration (Cmax) of PF708 and Forteo [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Change in serum calcium concentration after a single subcutaneous dose of PF708 and Forteo [ Time Frame: 0-24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02656810


Locations
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United States, Indiana
Covance Clinical Research Unit
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Pfenex, Inc
Investigators
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Study Director: Hubert C Chen, M.D. Pfenex, Inc

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Responsible Party: Pfenex, Inc
ClinicalTrials.gov Identifier: NCT02656810     History of Changes
Other Study ID Numbers: PF708-101
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Teriparatide
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Bone Density Conservation Agents