Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Denosumab (AMG 162) in Japanese Postmenopausal Women
Study Details
The primary objective was to evaluate the safety and tolerability of denosumab (AMG 162) after a single subcutaneous administration in Japanese postmenopausal women.
Protocol Summary
Number of Participants with Adverse Events
Timeframe: up to 37 weeks
Area under the serum concentration time curve from time 0 to time of last quantifiable serum concentration (AUC0-t) of denosumab
Timeframe: Day 1 (before dose) and afterdose: 5 minutes; 1, 4, 8, 12, 24, 48, 72, 96, 120, 168, 240, and 336 hours; and days 22, 29, 43, 57, 71, 85, 99, and 113.
Maximum observed concentration of denosumab (Cmax)
Timeframe: Day 1 (before dose) and afterdose: 5 minutes; 1, 4, 8, 12, 24, 48, 72, 96, 120, 168, 240, and 336 hours; and days 22, 29, 43, 57, 71, 85, 99, and 113.
Time of maximum observed concentration of denosumab
Timeframe: Day 1 (before dose) and afterdose: 5 minutes; 1, 4, 8, 12, 24, 48, 72, 96, 120, 168, 240, and 336 hours; and days 22, 29, 43, 57, 71, 85, 99, and 113.
Apparent Clearance (CL/F)
Timeframe: Day 1 (before dose) and afterdose: 5 minutes; 1, 4, 8, 12, 24, 48, 72, 96, 120, 168, 240, and 336 hours; and days 22, 29, 43, 57, 71, 85, 99, and 113.
Mean Residdence Time (MRT) from time 0 to time of last quantifiable serum concentration
Timeframe: Day 1 (before dose) and afterdose: 5 minutes; 1, 4, 8, 12, 24, 48, 72, 96, 120, 168, 240, and 336 hours; and days 22, 29, 43, 57, 71, 85, 99, and 113.
Maximum Decrease from Baseline in Urinary N-Telopeptide Corrected for Urine Creatinine (N-Tx/Cr)
Timeframe: Baseline and day 2, 3, 4, 5, 6, 8, 11, 15, 22, 29, 43, 57, 71, 85, 99, 113, 141, 169, 197, 225, and 253.