Single Ascending-Dose Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in Healthy Postmenopausal Women

NCT01159873 | Terminated Phase 1

• 1 other identifier: C37251/1080
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Study to Characterize the Safety, Pharmacokinetics, and Pharmacodynamics of CEP-37251 in Healthy Postmenopausal Women.

Conditions

Bone Loss; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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.

  70 days

Secondary Outcomes (2)

• Characterize the Overall Pharmacokinetic Profile of CEP-37251

  70 days

• Characterize the Overall Pharmacodynamic Effect of CEP-37251

  70 days

Study Arms (2)

CEP-37251

EXPERIMENTAL

Drug: CEP-37251

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

CEP-37251 DRUG

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.

CEP-37251

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cephalon: lead

Study Sites (1)

Cephalon Investigational Site

Adelaide, 5000, Australia

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Sr. Director, Clinical Pharmacology and Experimental Medicine, MD

  Cephalon

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 12, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: May 12, 2014

Record last verified: 2014-05

Locations

AU (1)