Bone LossPhase 1NCT01159873
Single Ascending-Dose Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in Healthy Postmenopausal Women
A Phase 1 study testing CEP-37251 in people with Bone Loss and Osteoporosis, run by Cephalon at 1 site in Australia.
Trial summary
Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in Healthy Postmenopausal Women. Read more about this study
- Who is it for?
- Ages 40 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Osteoporosis
- What is being tested?
- CEP-37251
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2010to Oct 2010
- 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 40 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The subject is a postmenopausal woman aged 40 years or greater but less than 75 years.
- The subject is ambulatory and healthy as judged by medical examination, medical history, and clinical chemistry, hematology and urinalysis at screening.
- The subject has a body weight greater than 50 kg but no more than 100 kg with a body mass index (BMI) of 18 to 35 kg/m2).
- The subject has a normal or clinically acceptable ECG.
- The subject is willing to give written informed consent prior to any study-related procedures being conducted.
- The subject is willing and able to comply with the study restrictions and to remain in the study center for the required inpatient period.
Who cannot join
- The subject has received any of the following medications within the 6 months prior to enrollment:
- hormone replacement therapy
- selective estrogen receptor modulator (SERM) therapy such as raloxifene
- elemental calcium supplementation >1.5 g/day
- Vitamin D supplementation >1000 IU per day
- calcitriol or other Vitamin D analogs (eg, alfacalcidol, doxercalciferol, or paricalcitol)
Show all 35Show fewer
- calcitonin or parathyroid hormone
- chronic use of glucocorticoids NOTE: Acute use of glucocorticoids may be permitted after consultation with the medical monitor if it occurred a minimum of 6 weeks prior to enrollment
- anabolic steroids
- The subject has received bisphosphonates or fluoride within the 12 months prior to enrollment.
- The subject has any of the following concomitant conditions:
- hypo- or hyperthyroidism. NOTE: Subjects with treated hypothyroidism with normal thyroid parameters may be allowed to participate in the study at the discretion of the investigator and medical monitor.
- hypo- or hyperparathyroidism
- recent fracture (within 6 months)
- osteomalacia, Paget's Disease, osteopetrosis, osteogenesis imperfect, or other bone disease
- rheumatoid arthritis or psoriatic arthritis
- acute osteoarthritis or gout
- chronic kidney disease or renal failure defined as an eGFR (by MDRD equation) 30 mL/min/1.73 m2 or less
- The subject is receiving immunosuppressant drugs.
- The subject is currently participating in another investigational study or has received any investigational drug within 60 days before the dose of study drug.
- The subject has evidence of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral disease, or malabsorption syndrome.
- The subject has a known history or evidence of malignancy, lymphoproliferative, or neoplastic disease with the exception of being successfully treated for basal or squamous cell carcinoma of the skin or cervical intraepithelial neoplasia.
- The subject has had any substantial change in levels of physical activity or participated in intense physical activity (e.g., marathon training) within the 6 months prior to the dose of study drug.
- The subject has any other clinically significant disease or disorder or factors, such as substance abuse, which in the opinion of the investigator, make the subject ineligible for participation in this study.
- The subject has a known or suspected hypersensitivity or idiosyncratic reaction to any compound present in the study drug or placebo.
- The subject has habitually consumed, within the past 2 years, more than 21 units of alcohol per week, or has a history of alcohol, narcotic, or any other substance abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR). NOTE: A unit of alcohol is equal to approximately 30 ml of spirits, 100 ml of wine, or 260 ml of full-strength beer.
- The subject has, within 2 weeks before administration of the dose of study drug, a clinically significant excessive consumption of coffee, tea, and/or other caffeine-containing beverage or food (i.e., 600 mg of caffeine or more per day, or 5 or more cups of coffee per day), or a combination of any of these beverages or foods.
- The subject has had, within 4 weeks before the dose of study drug, a clinically significant illness or, within 1 week before the dose of study drug, has had any acute illness, or at screening or on the day before the dose of study drug, has symptoms of any clinically significant or acute illness.
- The subject has, after resting for 5 minutes, elevated blood pressure (defined as a systolic blood pressure of more than 140 mm Hg for subjects ≤50 years of age or 155 mm Hg for subjects >50 years of age and/or a diastolic blood pressure of more than 90 mm Hg) or has low blood pressure (defined as systolic blood pressure of less than 90 mm Hg and/or diastolic blood pressure of less than 45 mm Hg).
- The subject has, after resting for 5 minutes, a pulse less than 45 beats per minute (bpm). The subject has, after resting for 5 minutes, a pulse more than 90 bpm for subjects ≤50 years of age or a pulse more than 100 bpm for subjects >50 years of age.
- The subject has a positive test result for hepatitis B surface antigen (HBsAg) or antibodies to hepatitis C or human immunodeficiency virus (HIV).
- History of any clinically important drug and/or vaccine allergies.
- The subject has received immunization with a live or live attenuated vaccine within 3 months prior to the dose of study drug or has immunization with a live or live attenuated vaccine planned within 3 months after the dose of study drug.
- The subject has an ongoing active systemic infection requiring treatment or a history of severe infection, such as hepatitis or pneumonia, in the 3 months prior to the dose of study drug. Less severe infections in the 3 months prior to the dose of study drug are permitted at the discretion of the investigator and medical monitor.
- The subject has a positive alcohol serum, urine, or breath test result or a positive urine drug screen (UDS).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending-Dose Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in Healthy Postmenopausal Women
Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in Healthy Postmenopausal Women.
- Conditions
- Bone Loss, Osteoporosis
- Being tested
- CEP-37251, Placebo
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEP-37251Drug
up to 5 subcutaneous (sc) doses (given sequentially in cohort groups) of CEP-37251 (0.03, 0.1, 0.3, 1.0, and 3.0 mg/kg) will be studied. After all 5 sc doses have been studied, an intravenous (iv) dose of 0.3 mg/kg will be studied.
PlaceboDrug
up to 5 subcutaneous (sc) doses (given sequentially in cohort groups) of Placebo (0.03, 0.1, 0.3, 1.0, and 3.0 mg/kg) will be studied. After all 5 sc doses have been studied, an intravenous (iv) placebo dose of 0.3 mg/kg will be studied.
| Study group | Role | What they receive |
|---|---|---|
| CEP-37251 | Experimental | Not described Receives: Drug: CEP-37251 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the Overall Safety Assessment of CEP-37251
Measurements include adverse events, laboratory results, vital sign measurements, electrocardiogram findings, physical examination findings, injection site evaluations, concomitant medication usage, immunophenotyping test results, and immunogenicity test results.
Measured: 70 days
Secondary outcomes (2)
Characterize the Overall Pharmacokinetic Profile of CEP-37251
Pharmacokinetic parameters include Cmax (Maximum Concentration) and AUC (Area Under the Curve) plasma concentration
Measured: 70 days
Characterize the Overall Pharmacodynamic Effect of CEP-37251
Pharmacodynamic effect as measured by markers of bone metabolism
Measured: 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2010
- Study completionOct 2010
Why it stopped: Study has been stopped by sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cephalon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sr. Director, Clinical Pharmacology and Experimental Medicine, MD, Study director, Cephalon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159873
- Sponsor's protocol ID
- C37251/1080
- Status last verified
- May 2014
- First submitted
- 8 Jul 2010
- Last updated
- 12 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Ascending-Dose Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in Healthy Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01159873
- Acronym / sponsor ID
- C37251/1080
- Conditions
- Bone Loss, Osteoporosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study has been stopped by sponsor decision
- Enrolment
- 2 participants (actual)
- Lead sponsor
- CephalonIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 12 Jul 2010 (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.
Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in Healthy Postmenopausal Women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEP-37251 | Experimental | Drug: CEP-37251 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject is a postmenopausal woman aged 40 years or greater but less than 75 years.
- The subject is ambulatory and healthy as judged by medical examination, medical history, and clinical chemistry, hematology and urinalysis at screening.
- The subject has a body weight greater than 50 kg but no more than 100 kg with a body mass index (BMI) of 18 to 35 kg/m2).
- The subject has a normal or clinically acceptable ECG.
- The subject is willing to give written informed consent prior to any study-related procedures being conducted.
Key exclusion criteria (35 listed)
- The subject has received any of the following medications within the 6 months prior to enrollment:
- The subject has received bisphosphonates or fluoride within the 12 months prior to enrollment.
- The subject has any of the following concomitant conditions:
- The subject is receiving immunosuppressant drugs.
- The subject is currently participating in another investigational study or has received any investigational drug within 60 days before the dose of study drug.
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 |
|---|---|---|
| CEP-37251up to 5 subcutaneous (sc) doses (given sequentially in cohort groups) of CEP-37251 (0.03, 0.1, 0.3, 1.0, and 3.0 mg/kg) will be studied. After all 5 sc doses have been studied, an intravenous (iv) dose of 0.3 mg/kg will be studied. | Drug | CEP-37251 |
| Placeboup to 5 subcutaneous (sc) doses (given sequentially in cohort groups) of Placebo (0.03, 0.1, 0.3, 1.0, and 3.0 mg/kg) will be studied. After all 5 sc doses have been studied, an intravenous (iv) placebo dose of 0.3 mg/kg will be studied. | Drug | Placebo |
Primary outcome
Characterize the Overall Safety Assessment of CEP-37251
Time frame: 70 days
Measurements include adverse events, laboratory results, vital sign measurements, electrocardiogram findings, physical examination findings, injection site evaluations, concomitant medication usage, immunophenotyping test results, and immunogenicity test results.
2 secondary outcomes
Characterize the Overall Pharmacokinetic Profile of CEP-37251
Time frame: 70 days
Characterize the Overall Pharmacodynamic Effect of CEP-37251
Time frame: 70 days
Results and safety
The study was stopped early (reason given: Study has been stopped by sponsor decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2014.
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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.
Sr. Director, Clinical Pharmacology and Experimental Medicine, MD study director
Cephalon
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 CEP-37251 in people with Bone Loss and Osteoporosis, run by Cephalon at 1 site in Australia.
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 6 inclusion and 35 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: stopped early, as of the sponsor's last update on 12 May 2014. 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 Australia. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Study has been stopped by sponsor decision). Results are not available in the source record.
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?
Characterize the Overall Safety Assessment of CEP-37251 (time frame: 70 days). 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 12 May 2014.