A First-in-human Study Evaluating AMG 167 in Healthy Men and Postmenopausal Women

NCT00902356 | Completed Phase 1

• 1 other identifier: 20080049
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to determine the safety and tolerability of AMG 167 following a single dose subcutaneous (SC) or intravenous (IV) administration in healthy men and postmenopausal women.

Conditions

Osteopenia

Keywords

Amgen; Phase 1; First in Human; Postmenopausal

Outcome Measures

Primary Outcomes (3)

• The number (percent) of subjects reporting treatment-emergent adverse events.

  Cohort 1 - 29 days; cohorts 2, 3, 6, and 7 - 57 days; cohorts 4, 5, 8, and 9 - 85 days

• The number of subjects experiencing clinically significant changes in safety laboratory tests, physical examinations, vital signs, or electrocardiograms (ECGs).

  Cohort 1 - 29 days; cohorts 2, 3, 6, and 7 - 57 days; cohorts 4, 5, 8, and 9 - 85 days

• The number of subjects who develop anti-AMG 167 antibodies.

  Cohort 1 - 29 days; cohorts 2, 3, 6, and 7 - 57 days; cohorts 4, 5, 8, and 9 - 85 days

Secondary Outcomes (1)

• Pharmacokinetic and phamacodynamic parameters [serum procollagen type 1 N-terminal propeptide (P1NP), BSAP, osteocalcin, sCTX, sclerostin levels, and bone mineral density (BMD) for higher dose levels] after single dose SC or IV administration of AMG 167.

  Cohort 1 - 29 days; cohorts 2, 3, 6, and 7 - 57 days; cohorts 4, 5, 8, and 9 - 85 days

Study Arms (2)

B

ACTIVE COMPARATOR

Six female subjects in each of cohorts 1 to 5 will receive AMG 167; six male subjects in each of cohorts 6 and 8; three female subjects in each of cohorts 7 and 9.

Drug: Placebo

A

PLACEBO COMPARATOR

Two female subjects in each of cohorts 1 to 5 will receive placebo; two male subjects in each of cohorts 6 and 8; and 1 female subject in each of cohorts 7 and 9.

Drug: AMG 167

Interventions

AMG 167 DRUG

Subjects will be randomized to receive 1 of 5 doses of AMG 167 or equivalent volume of placebo administered as a single dose. Postmenopausal women will receive AMG 167 in fixed doses of 21 mg, 70, 210, 350, or 700 mg SC (under the skin), or 70 mg or 350 mg IV (in the vein), while men will receive doses of 70 mg or 350 mg SC or IV.

A

Placebo DRUG

Subjects will be randomized to receive 1 of 5 doses of AMG 167 or equivalent volume of placebo administered as a single dose. Postmenopausal women will receive AMG 167 in fixed doses of 21 mg, 70, 210, 350, or 700 mg SC (under the skin), or 70 mg or 350 mg IV (in the vein), while men will receive doses of 70 mg or 350 mg SC or IV.

B

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males and females between 45 to 65 years of age
• Postmenopausal females defined as 12 continuous months of spontaneous amenorrhea confirmed by a serum follicle-stimulating hormone (FSH) result \> 40mIU/mL, or at least 6 weeks postsurgical bilateral oophorectomy (with or without hysterectomy)
• Men must agree to use highly effective methods of contraception; males must agree to not donate sperm for the entire study and 7 months after the end of treatment
• Weight ≤ 98 kg (216 lb) and/or height ≤ 196 cm (77 in)
• Has no history or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
• Negative urine screen for potential drugs of abuse at screening and admission, unless medication is prescribed by a physician

You may not qualify if:

• Healthy males with partners who are pregnant at the time of screening; or healthy males with partners who plan to become pregnant during the study
• Osteoporosis, as defined by BMD t-scores of the lumbar spine (L1-L4) or total evaluable vertebrae; or femoral neck ≤ 2.5
• Diagnosed with any condition that will affect bone metabolism
• Diagnosis of clotting factor deficiency or history of bleeding or coagulation disorder (including history of heparin or warfarin administration)
• Subjects with fewer than 2 evaluable vertebrae; metal in hips bilaterally that would not allow for at least one evaluable hip; metal in forearms bilaterally that would not allow for at least one evaluable forearm
• Abnormal international normalized ratio or partial thromboplastin time
• Administration of the following medications within 6 months before study drug administration:
• Hormone replacement therapy \[Infrequent use of estrogen vaginal creams (\< 3 times per week) is allowed.\]
• Calcitonin
• Parathyroid hormone (or any derivative)
• Supplemental Vitamin D \> 1,000 IU/day
• Glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the enrollment date are allowed)
• Anabolic steroids
• Calcitriol, and available analogues
• Administration of the following medications within 12 months before study drug administration:

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

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

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 14, 2009
• First Posted: May 15, 2009
• Study Start: May 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 2, 2010

Record last verified: 2010-04