OsteoporosisPhase 1NCT02656810
A Comparison Study of PF708 and Forteo in Healthy Subjects
A Phase 1 study testing Teriparatide in people with Osteoporosis, run by Pfenex, Inc at 1 site in United States.
Trial summary
The purpose of this study is to compare the pharmacokinetics (blood levels) of two teriparatide products, PF708 and Forteo, in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Teriparatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Jul 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female aged 18-50 years at the time of Informed Consent.
- Able to understand and sign the written Informed Consent Form (ICF).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit
Evansville, Indiana, 47710
About this study
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
The purpose of this study is to compare the pharmacokinetics (blood levels) of two teriparatide products, PF708 and Forteo, in healthy subjects.
Read the 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),
- Conditions
- Osteoporosis
- Being tested
- Teriparatide
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeriparatideDrug
Also called PF708
Single subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Sequence A | Experimental | Single subcutaneous injection of two teriparatide products (PF708 and Forteo) Receives: Drug: Teriparatide |
| Sequence B | Experimental | Single subcutaneous injection of two teriparatide products (Forteo and PF708) Receives: Drug: Teriparatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum area-under-the-curve (AUC) of PF708 and Forteo
Measured: 24 hours
Serum maximum concentration (Cmax) of PF708 and Forteo
Measured: 24 hours
Secondary outcomes (1)
Change in serum calcium concentration after a single subcutaneous dose of PF708 and Forteo
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startDec 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfenex, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hubert C Chen, M.D., Study director, Pfenex, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02656810
- Sponsor's protocol ID
- PF708-101
- Status last verified
- Aug 2016
- First submitted
- 12 Jan 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02656810
- Acronym / sponsor ID
- PF708-101
- Conditions
- Osteoporosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Pfenex, IncIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | Drug: TeriparatideSingle subcutaneous injection of two teriparatide products (PF708 and Forteo) |
| Sequence B | Experimental | Drug: TeriparatideSingle subcutaneous injection of two teriparatide products (Forteo and PF708) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male or female aged 18-50 years at the time of Informed Consent.
- Able to understand and sign the written Informed Consent Form (ICF).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TeriparatideAlso: PF708Single subcutaneous injection | Drug | Sequence A, Sequence B |
Primary outcome
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
1 secondary outcome
Change in serum calcium concentration after a single subcutaneous dose of PF708 and Forteo
Time frame: 0-24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hubert C Chen, M.D. study director
Pfenex, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Teriparatide in people with Osteoporosis, run by Pfenex, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum area-under-the-curve (AUC) of PF708 and Forteo (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.