Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Comparison Study of PF708 and Forteo in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 12, 2016
First Posted Date  ICMJE January 15, 2016
Last Update Posted Date August 4, 2016
Study Start Date  ICMJE December 2015
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2016)
  • Serum area-under-the-curve (AUC) of PF708 and Forteo [ Time Frame: 24 hours ]
  • Serum maximum concentration (Cmax) of PF708 and Forteo [ Time Frame: 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2016)
Change in serum calcium concentration after a single subcutaneous dose of PF708 and Forteo [ Time Frame: 0-24 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comparison Study of PF708 and Forteo in Healthy Subjects
Official Title  ICMJE A Double-Masked, Randomized, Two-Treatment Cross-over Study Comparing the Pharmacokinetics of PF708 and Forteo Administered by Subcutaneous Injection in Healthy Adult Subjects
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),
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoporosis
Intervention  ICMJE Drug: Teriparatide
Single subcutaneous injection
Other Name: PF708
Study Arms  ICMJE
  • Experimental: Sequence A
    Single subcutaneous injection of two teriparatide products (PF708 and Forteo)
    Intervention: Drug: Teriparatide
  • Experimental: Sequence B
    Single subcutaneous injection of two teriparatide products (Forteo and PF708)
    Intervention: Drug: Teriparatide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2016)
70
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02656810
Other Study ID Numbers  ICMJE PF708-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Pfenex, Inc
Study Sponsor  ICMJE Pfenex, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hubert C Chen, M.D. Pfenex, Inc
PRS Account Pfenex, Inc
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP