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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01159873




Registration number
NCT01159873
Ethics application status
Date submitted
8/07/2010
Date registered
12/07/2010
Date last updated
12/05/2014

Titles & IDs
Public title
Single Ascending-Dose Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in Healthy Postmenopausal Women
Scientific 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
Secondary ID [1] 0 0
C37251/1080
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bone Loss 0 0
Osteoporosis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoporosis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - CEP-37251
Treatment: Drugs - Placebo

Experimental: CEP-37251 -

Placebo Comparator: Placebo -


Treatment: Drugs: CEP-37251
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.

Treatment: Drugs: Placebo
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Characterize the Overall Safety Assessment of CEP-37251
Timepoint [1] 0 0
70 days
Secondary outcome [1] 0 0
Characterize the Overall Pharmacokinetic Profile of CEP-37251
Timepoint [1] 0 0
70 days
Secondary outcome [2] 0 0
Characterize the Overall Pharmacodynamic Effect of CEP-37251
Timepoint [2] 0 0
70 days

Eligibility
Key inclusion criteria
- 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.
Minimum age
40 Years
Maximum age
74 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- 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)

- 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2010
Sample size
Target
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Cephalon Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Cephalon
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in
Healthy Postmenopausal Women.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01159873
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sr. Director, Clinical Pharmacology and Experimental Medicine, MD
Address 0 0
Cephalon
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01159873