Study Complete
Sponsor ID
20030164

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

Sponsor ID
20030164
Clinicaltrials.gov ID
NCT03822078
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
denosumab
Type
Interventional
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Enrollment
45
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants with Adverse Events

Timeframe: up to 37 weeks

Secondary Outcome Measures

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.

Locations

No locations found.