Skip to main content
OpenTrials
Completed

NCT Number: NCT02656810

A Comparison Study of PF708 and Forteo in Healthy Subjects

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit

Evansville, Indiana, 47710, United States

About this study

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),

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Teriparatide

Drug

Single subcutaneous injection

Other names: PF708

Primary outcomes

  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 outcomes

  1. Change in serum calcium concentration after a single subcutaneous dose of PF708 and Forteo

    Time frame: 0-24 hours

Sponsors and collaborators

Lead sponsor

Pfenex, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 15, 2016
Registry last updated
Aug 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.