Pharmacokinetic, Safety and Tolerability Study of SC Administered Bisphosphonate With rHuPH20 vs Bisphosphonate Alone

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Halozyme Therapeutics.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Halozyme Therapeutics
ClinicalTrials.gov Identifier:
NCT00807963
First received: December 11, 2008
Last updated: June 3, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Risk Factors for or a Diagnosis of Osteoporosis
Drug: rHuPH20
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Official Title: Phase I, Open-Label, Pharmacokinetic, Safety and Tolerability Study of Subcutaneously Administered Bisphosphonate With Recombinant Human Hyaluronidase (rHuPH20) vs Bisphosphonate

Resource links provided by NLM:


Further study details as provided by Halozyme Therapeutics:

Primary Outcome Measures:
  • Assessment of local tolerability of injected drug product [ Time Frame: Over a 7 day period ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 72
Study Start Date: December 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: rHuPH20
    recombinant human hyaluronidase PH20
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

  • 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.
  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807963

Locations
United States, Texas
Healthcare Discoveries, LLC/ICON Development Solutions
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Halozyme Therapeutics
Investigators
Principal Investigator: Emanuel P DeNoia, MD Healthcare Discoveries, LLC/ICON
  More Information

No publications provided

Responsible Party: Samuel S. Dychter, M.D., Halozyme Therapeutics
ClinicalTrials.gov Identifier: NCT00807963     History of Changes
Other Study ID Numbers: HZ2-08-02
Study First Received: December 11, 2008
Last Updated: June 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Halozyme Therapeutics:
Pharmacokinetics
rHuPH20

Additional relevant MeSH terms:
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014