Phase 1 N=45 Randomized Triple-blind Treatment

Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women

Osteoporosis

Bottom Line

View on ClinicalTrials.gov: NCT03822078 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2019

Primary outcome: Primary: Number of Participants With Adverse Events — 6; 2; 3; 5 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Placebo (Drug); Denosumab (Biological)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Amgen
Primary completion: Dec 2004

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Adverse Events	6; 2; 3; 5; 6; 5	—
SECONDARY Area Under the Serum Concentration Time Curve From Time 0 to Time of Last Quantifiable Serum Concentration (AUC0-t) of Denosumab	2.06; 15.2; 84.3; 481; 1790	—
SECONDARY Maximum Observed Concentration of Denosumab (Cmax)	99.6; 492; 1910; 8690; 27400	—
SECONDARY Time to Maximum Observed Concentration (Tmax) of Denosumab	7.0; 12.0; 14.0; 14.0; 14.0	—
SECONDARY Apparent Clearance (CL/F) of Denosumab	15.3; 8.31; 3.72; 2.20; 1.85	—
SECONDARY Mean Residence Time (MRT) From Time 0 to Time of Last Quantifiable Serum Concentration	15.5; 22.5; 33.6; 42.6; 51.4	—
SECONDARY Percent Change From Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)	12; 6; -25; -22; -40; -64	—
SECONDARY Percent Change From Baseline in Bone-Specific Alkaline Phosphatase (BSAP)	-0.4; -6.9; 16.6; 7.1; -0.5; 3.1	—
SECONDARY Percent Change From Baseline in Intact Parathyroid Hormone (iPTH)	6.9; 2.4; 10.1; 44.0; 40.9; 129.0	—

Summary

The primary objective was to evaluate the safety and tolerability of denosumab (AMG 162) after a single subcutaneous administration in Japanese postmenopausal women.

Eligibility Criteria

Inclusion Criteria

ambulatory women between the ages of 40 and 64 years, inclusive
postmenopausal, defined as amenorrheic for at least 24 months
clinically acceptable physical exam
clinical laboratory tests (complete blood count [CBC], blood chemistries, urinalysis) within normal limits or clinically acceptable to the investigator/sponsor at the time of screening with the exception of aspartate transaminase (AST) and alkaline phosphatase (ALT), which must be 1000 IU/day), glucocorticosteroids (inhaled or topical corticosteroids administered more than 2 weeks before the date of informed consent were allowed), anabolic steroids, calcitriol and available analogues, diuretics
administration of the following medications within 12 months before study drug administration: bisphosphonates, fluoride for osteoporosis
diagnosed with any condition that affects bone metabolism
greatly differing levels of physical activity compared with the 6 months before investigational product administration or constant levels of intense physical activities
routine alcohol intake of ≥ 2 drinks/day, on average, within 6 months of investigational product administration
known sensitivity to any drugs
positive test results for hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus antigen/antibody, syphilis
receiving or received any investigational drug (or was currently using an investigational device) within 4 months before receiving investigational product
donated any amount of blood within 16 weeks, or over 400 mL (Note: not 400 mL but 200 mL, for the subjects who were to be enrolled into cohorts 4 or 5) within 1 year of the start day of screening
subject had previously entered this study
any other condition that might have reduced the chance of obtaining data (eg, known poor compliance) required by the protocol or that might have compromised the ability to give truly informed consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03822078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.