A Single-dose Study Evaluating AMG 785 in Healthy Postmenopausal Japanese Women

This study has been completed.
Sponsor:
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT01101061
First received: April 8, 2010
Last updated: March 31, 2011
Last verified: March 2011
  Purpose

The purpose of this study is to assess the safety, tolerability and potential immune response of AMG 785 following single subcutaneous (SC, injection under the skin) dose administration in healthy postmenopausal Japanese women.


Condition Intervention Phase
Osteopenia
Drug: AMG 785
Drug: PLACEBO
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Single-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 785 in Healthy Postmenopausal Japanese Women

Further study details as provided by Amgen:

Primary Outcome Measures:
  • The number (percent) of subjects experiencing clinically significant changes in vital signs, physical exams, laboratory safety tests, and ECGs [ Time Frame: A maximum of 85 days following investigational product administration. ] [ Designated as safety issue: Yes ]
  • The number (percent) of subjects who develop anti-AMG 785 antibodies [ Time Frame: A maximum of 85 days following investigational product administration. ] [ Designated as safety issue: Yes ]
  • The number (percent) of subjects reporting treatment-emergent adverse events [ Time Frame: A maximum of 85 days following investigational product administration. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic (PK) and pharmacodynamic (PD) parameters [procollagen type 1 N-terminal propeptide (P1NP), serum C-telopeptide (sCTX) and sclerostin] following single subcutaneous (SC) dose administration in Japanese and non-Japanese women [ Time Frame: A maximum of 85 days following investigational product administration. ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: May 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AMG 785
Six (6) Japanese women in cohorts 1, 2, and 4 will receive a single weight-based dose of AMG 785. Four (4) non-Japanese women in cohort 3 will receive a single weight-based dose of AMG 785.
Drug: PLACEBO
Subjects will be randomized to receive one of 3 dose levels of AMG 785 or equivalent volume of placebo administered as a single weight-based dose. Postmenopausal Japanese women will receive AMG 785 at a dose level of 1 mg/kg, 3 mg/kg, or 5 mg/kg. Postmenopausal non-Japanese women will receive AMG 785 at a dose level of 3 mg/kg.
Placebo Comparator: PLACEBO
Two (2) women in each of cohorts 1, 2, 3, and 4 will receive a single dose of placebo.
Drug: AMG 785
Subjects will be randomized to receive one of 3 dose levels of AMG 785 or equivalent volume of placebo administered as a single weight-based dose. Postmenopausal Japanese women will receive AMG 785 at a dose level of 1 mg/kg, 3 mg/kg, or 5 mg/kg. Postmenopausal non-Japanese women will receive AMG 785 at a dose level of 3 mg/kg.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Japanese subjects must be first (4 grandparents, biologic parents and subject born in Japan), second (4 grandparents and biological parents born in Japan) or third (4 grandparents born in Japan) generation Japanese
  • Body mass index ≤ 25 kg/m2, inclusive at screening
  • Postmenopausal females defined as 12 continuous months of spontaneous amenorrhea confirmed by a serum follicle-stimulating hormone (FSH) result > 40mIU/mL, or 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy) as documented in medical history (verified with an operative note, if available)

Exclusion Criteria:

  • Osteoporosis, as defined by bone mineral density (BMD) T-scores of the lumbar spine (L1-L4) or total evaluable vertebrae (if fewer than L1-L4); or femoral neck ≤ -2.5
  • History of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis;
  • Diagnosed with any condition that will affect bone metabolism
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101061

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Global Development Leader, Amgen Inc.
ClinicalTrials.gov Identifier: NCT01101061     History of Changes
Other Study ID Numbers: 20090378
Study First Received: April 8, 2010
Last Updated: March 31, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Amgen
Phase 1
Postmenopausal
Japanese

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 31, 2014