Risk Factors for or a Diagnosis of OsteoporosisPhase 1NCT00807963
Pharmacokinetic, Safety and Tolerability Study of SC Administered Bisphosphonate With rHuPH20 vs Bisphosphonate Alone
A Phase 1 study testing rHuPH20 and zoledronic acid in people with Risk Factors for or a Diagnosis of Osteoporosis, run by Halozyme Therapeutics at 1 site in United States.
Trial summary
The purpose of this study is to determine the maximum tolerated concentration (MTC) of bisphosphonate with a fixed dose of rHuPH20 administered SC, the MTC of bisphosphonate without rHuPH20 administered SC, the optimal dose of rHuPH20 to deliver bisphosphonate SC at MTC, and to compare the PK of SC administered… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Risk Factors for or a Diagnosis of Osteoporosis
- What is being tested?
- rHuPH20 and zoledronic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to 21 Sep 2009
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female volunteers 18 to 60 years of age, inclusive.
- Intact normal skin in the area intended for administration.
- Adequate venous access in both upper extremities.
- Dental examination by an appropriately trained professional within 14 days of administration demonstrating no signs, symptoms, or risk factors of osteonecrosis of the jaw (ONJ).
- Vital signs (BP, HR, temperature, respiratory rate) within normal range or, if out of range, assessed by the Investigator as not clinically significant and it is mutually agreed by both Investigator and Sponsor Medical Monitor that the subject need not be excluded from the study for this reason.
- Electrocardiogram within normal range or if out of range, assessed by the Investigator as not clinically significant and it is mutually agreed by both Investigator and Sponsor Medical Monitor that the subject need not be excluded from the study for this reason.
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- Within 14 days prior to administration, metabolic panel (e.g., sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose, calcium, AST, ALT, alkaline phosphatase, total bilirubin, albumin, and total protein) and complete blood count within the laboratory normal reference range or, if out of range, assessed by the Investigator as not clinically significant and it is mutually agreed by both Investigator and Sponsor Medical Monitor that the subject need not be excluded from the study for this laboratory value.
- A negative serum or urine pregnancy test (if female of child-bearing potential) within 14 days of study drug administration.
- Female subjects of child-bearing potential must agree to be currently practicing effective birth control or abstinence and agree to continue to do so for at least 30 days after duration of their time on study.
- Decision-making capacity and willingness and ability to comply with the requirements for full completion of the trial.
- Signed, written IRB/EC-approved informed consent.
Who cannot join
- Lower extremity edema.
- Lower extremity pathology that could interfere with any protocol-specified outcome assessment (e.g., cellulitis, lymphatic disorder or prior surgery, pre-existing pain syndrome, auxiliary lymph node dissection, etc.).
- Creatinine clearance < 60 mL/min (Cockcroft-Gault formula).
- Any risk factor for bisphosphonate-related renal toxicity including by not limited to known predisposition to or history of renal insufficiency or renal failure, hypertension, diabetes mellitus, volume depletion, sepsis, paraproteinemia, and subjects receiving known nephrotoxic drugs.
- Dehydration Grade 2 or higher based on NCI CTCAE V3.0.
- Known parathyroid gland dysfunction or any other disease that could lower blood calcium levels.
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- Known history and/or electrocardiographic evidence of atrial fibrillation.
- Known allergy to any hyaluronidase.
- Bisphosphonate treatment within preceding six months.
- Known allergy or intolerance to any bisphosphonate.
- Pregnancy or breast-feeding woman.
- Known clinically significant cardiovascular, gastrointestinal, hepatic, neurological, psychiatric, endocrine, cancer, HIV infection, diabetes mellitus, intercurrent illness such as influenza, or other major systemic disease that would unduly risk the subject's safety or interfere with the interpretation of results.
- Participation in a study of any investigational drug or device within 30 days of enrollment in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Healthcare Discoveries, LLC/ICON Development Solutions
San Antonio, Texas, 78209
About this study
Official title: Phase I, Open-Label, Pharmacokinetic, Safety and Tolerability Study of Subcutaneously Administered Bisphosphonate With Recombinant Human Hyaluronidase (rHuPH20) vs Bisphosphonate
The purpose of this study is to determine the maximum tolerated concentration (MTC) of bisphosphonate with a fixed dose of rHuPH20 administered SC, the MTC of bisphosphonate without rHuPH20 administered SC, the optimal dose of rHuPH20 to deliver bisphosphonate SC at MTC, and to compare the PK of SC administered bisphosphonate at MTC with optimal dose rHuPH20 to bisphosphonate alone.
- Being tested
- rHuPH20, zoledronic acid
- Keywords
- Pharmacokinetics, rHuPH20
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rHuPH20Drug
recombinant human hyaluronidase PH20 injection
zoledronic acidDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Stage 1: rHuPH20 plus ZA | Experimental | Participants will receive one of several dose/concentrations of recombinant human hyaluronidase PH20 (rHuPH20) with zoledronic acid (ZA). Receives: Drug: rHuPH20; Drug: zoledronic acid |
| Stage 2: ZA | Experimental | Participants will receive a dose/concentration of ZA administered without rHuPH20. Receives: Drug: zoledronic acid |
| Stage 3: rHuPH20 plus ZA | Experimental | Participants will receive one of several dose/concentrations of rHuPH20 with ZA. Receives: Drug: rHuPH20; Drug: zoledronic acid |
| Stage 4: ZA | Experimental | Participants will receive an intravenous (IV) dose of 5 milligrams (mg) ZA. Receives: Drug: zoledronic acid |
| Stage 4: ZA with rHuPH20 | Experimental | Participants will receive a subcutaneous (SC) dose of ZA with rHuPH20. Receives: Drug: rHuPH20; Drug: zoledronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of local tolerability of injected drug product
Measured: Over a 7 day period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2008 (estimated)
- Study startDec 2008
- Primary completion21 Sep 2009
- Study completion21 Sep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Factors for or a Diagnosis of 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Halozyme Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emanuel P DeNoia, MD, Principal investigator, Healthcare Discoveries, LLC/ICON
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00807963
- Sponsor's protocol ID
- HZ2-08-02
- Status last verified
- Aug 2018
- First submitted
- 11 Dec 2008
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I, Open-Label, Pharmacokinetic, Safety and Tolerability Study of Subcutaneously Administered Bisphosphonate With Recombinant Human Hyaluronidase (rHuPH20) vs Bisphosphonate
- ClinicalTrials.gov ID
- NCT00807963
- Acronym / sponsor ID
- HZ2-08-02
- Keywords
- Pharmacokinetics, rHuPH20
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Halozyme TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- 21 Sep 2009 (actual)
- Study completion
- 21 Sep 2009 (actual)
- First posted
- 15 Dec 2008 (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 determine the maximum tolerated concentration (MTC) of bisphosphonate with a fixed dose of rHuPH20 administered SC, the MTC of bisphosphonate without rHuPH20 administered SC, the optimal dose of rHuPH20 to deliver bisphosphonate SC at MTC, and to compare the PK of SC administered bisphosphonate at MTC with optimal dose rHuPH20 to bisphosphonate alone.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Stage 1: rHuPH20 plus ZA | Experimental | Drug: rHuPH20, Drug: zoledronic acidParticipants will receive one of several dose/concentrations of recombinant human hyaluronidase PH20 (rHuPH20) with zoledronic acid (ZA). |
| Stage 2: ZA | Experimental | Drug: zoledronic acidParticipants will receive a dose/concentration of ZA administered without rHuPH20. |
| Stage 3: rHuPH20 plus ZA | Experimental | Drug: rHuPH20, Drug: zoledronic acidParticipants will receive one of several dose/concentrations of rHuPH20 with ZA. |
| Stage 4: ZA | Experimental | Drug: zoledronic acidParticipants will receive an intravenous (IV) dose of 5 milligrams (mg) ZA. |
| Stage 4: ZA with rHuPH20 | Experimental | Drug: rHuPH20, Drug: zoledronic acidParticipants will receive a subcutaneous (SC) dose of ZA with rHuPH20. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female volunteers 18 to 60 years of age, inclusive.
- Intact normal skin in the area intended for administration.
- Adequate venous access in both upper extremities.
- Dental examination by an appropriately trained professional within 14 days of administration demonstrating no signs, symptoms, or risk factors of osteonecrosis of the jaw (ONJ).
- Vital signs (BP, HR, temperature, respiratory rate) within normal range or, if out of range, assessed by the Investigator as not clinically significant and it is mutually agreed by both Investigator and Sponsor Medical Monitor that the subject need not be excluded from the study for this reason.
Key exclusion criteria (13 listed)
- Lower extremity edema.
- Lower extremity pathology that could interfere with any protocol-specified outcome assessment (e.g., cellulitis, lymphatic disorder or prior surgery, pre-existing pain syndrome, auxiliary lymph node dissection, etc.).
- Creatinine clearance < 60 mL/min (Cockcroft-Gault formula).
- Any risk factor for bisphosphonate-related renal toxicity including by not limited to known predisposition to or history of renal insufficiency or renal failure, hypertension, diabetes mellitus, volume depletion, sepsis, paraproteinemia, and subjects receiving known nephrotoxic drugs.
- Dehydration Grade 2 or higher based on NCI CTCAE V3.0.
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 |
|---|---|---|
| rHuPH20recombinant human hyaluronidase PH20 injection | Drug | Stage 1: rHuPH20 plus ZA, Stage 3: rHuPH20 plus ZA, Stage 4: ZA with rHuPH20 |
| zoledronic acidsubcutaneous injection | Drug | Stage 1: rHuPH20 plus ZA, Stage 2: ZA, Stage 3: rHuPH20 plus ZA, Stage 4: ZA, Stage 4: ZA with rHuPH20 |
Primary outcome
Assessment of local tolerability of injected drug product
Time frame: Over a 7 day period
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 15 Aug 2018.
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.
Emanuel P DeNoia, MD principal investigator
Healthcare Discoveries, LLC/ICON
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 rHuPH20 and zoledronic acid in people with Risk Factors for or a Diagnosis of Osteoporosis, run by Halozyme Therapeutics 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 11 inclusion and 13 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 15 Aug 2018. 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?
Assessment of local tolerability of injected drug product (time frame: Over a 7 day period). 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 15 Aug 2018.