The purpose of this study is to compare how rhPTH(1-84) affects the body between healthy adults of Japanese descent and matched, healthy Caucasian adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
25 mcg rhPTH(1-84) SC injection
50 mcg rhPTH(1-84) SC injection
100 mcg rhPTH(1-84) SC injection
Glendale Adventist Medical Center
Glendale, California, United States
Baseline-adjusted Cmax of PTH(1-84)
Baseline-adjusted maximum observed drug concentration (Cmax) of PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).
Time frame: 30 and 90 minutes (min) Pre-dose, 10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 hours (h) Post-dose
Baseline-adjusted Tmax of PTH(1-84)
Baseline-adjusted time to reach maximum observed drug concentration (Tmax) of PTH(1-84) in plasma was reported.
Time frame: 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose
Baseline-adjusted AUC(Last) of PTH(1-84) in Plasma
Baseline-adjusted area under the curve from the time of dosing to the last measurable concentration (AUC(last)) of PTH(1-84) was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).
Time frame: 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose
Baseline-adjusted AUC(0-8) of PTH(1-84) in Plasma
Baseline-adjusted area under the concentration versus time curve from the time of dosing to 8 hours post dose (AUC(0-8)) of PTH(1-84) was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).
Time frame: 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose
Baseline-adjusted AUC(0-inf) of PTH(1-84) in Plasma
Baseline-adjusted area under the concentration versus time curve extrapolated to infinity (AUC(0-inf)) of PTH(1-84) was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).
Time frame: 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose
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Baseline- Adjusted % of AUC(0-Inf) Extra of PTH(1-84) in Plasma
Baseline-adjusted % of AUC extrapolated from the last measurable concentration to infinity over (AUC(0-Inf)) of PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).
Time frame: 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose
Baseline-adjusted Lambda_z of PTH(1-84) in Plasma
Baseline-adjusted Lambda z associated with the terminal (log-linear) portion of the curve for PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).
Time frame: 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose
Baseline-adjusted t1/2 of PTH(1-84) in Plasma
Baseline-adjusted Terminal Half-life (t1/2) of PTH(1-84) in plasma was reported.
Time frame: 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose
Baseline-adjusted CL/F of PTH(1-84) in Plasma
Baseline-adjusted apparent clearance (CL/F) of PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).
Time frame: 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose
Baseline-adjusted Vdz/F of PTH(1-84) in Plasma
Baseline-adjusted apparent volume of distribution (Vdz/F) of PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).
Time frame: 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose
Original Cmax of PTH(1-84) in Plasma
Original maximum observed drug concentration (Cmax) of PTH(1-84) in plasma was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).
Time frame: 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose
Original Tmax of PTH(1-84)
The original time to reach maximum observed drug concentration (Tmax) of PTH(1-84) in plasma was reported.
Time frame: 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose
Original AUClast of PTH(1-84) in Plasma
Original area under the curve from the time of dosing to the last measurable concentration (AUClast) of PTH(1-84) was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).
Time frame: 30 and 90 min Pre-dose,10, 20, 30, 45 min, 1, 1.25, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16 and 24 h Post-dose
AUClast of Albumin-corrected Calcium, Serum Total Calcium and Phosphate Levels After Intake of PTH(1-84)
Area under the curve from the time of dosing to the last measurable concentration of albumin-corrected calcium, serum total calcium and phosphate levels after intake of PTH(1-84) was reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).
Time frame: Non-Hispanic Caucasians: 30 mins predose, 4, 8 and 12 h (Day 1),24 h (Day 2) Japanese Descents: 30 mins predose, 4, 8 and 12 h (Days 1, 4, 7), 24 h (Days 2, 5, 8)
TEmax After Intake of PTH(1-84) on Albumin-corrected Calcium, Serum Total Calcium and Serum Phosphate Levels
The time to maximum effect (TEmax) of PTH(1-84) on albumin-corrected calcium, serum total calcium and serum phosphate levels were reported.
Time frame: Non-Hispanic Caucasians: 30 mins predose, 4, 8 and 12 h (Day 1),24 h (Day 2) Japanese Descents: 30 mins predose, 4, 8 and 12 h (Days 1, 4, 7), 24 h (Days 2, 5, 8)
Emax of PTH(1-84) on Albumin-corrected Calcium, Serum Total Calcium and Serum Phosphate Levels
The maximum effect (Emax) of PTH(1-84) on albumin-corrected calcium, serum total calcium and serum phosphate levels were reported. The dispersion measure Geometric Coefficient of Variation was reported in percent (%).
Time frame: Non-Hispanic Caucasians: 30 mins predose, 4, 8 and 12 h (Day 1),24 h (Day 2) Japanese Descents: 30 mins predose, 4, 8 and 12 h (Days 1, 4, 7), 24 h (Days 2, 5, 8)
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment.
Time frame: From start of study drug administration to follow-up (up to 40 days)
Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests Reported as Treatment-emergent Adverse Events (TEAEs)
Clinical laboratory tests included hematology, chemistry, and urinalysis. Number of participants with clinically significant changes in clinical laboratory tests reported as TEAEs were reported.
Time frame: Non-Hispanic Caucasians: 30 min pre-dose,24 h,32 days post-dose Japanese Descents: 30 min pre-dose,24 h post-dose on Days 1,4,7 and 32 days after last dose
Number of Participants With Clinically Significant Changes in Vital Signs Reported as Treatment-emergent Adverse Events (TEAEs)
Vital signs were obtained while participant was supine. Vital signs included hematology, chemistry, and urinalysis. Number of participants with clinically significant changes in vital signs reported as TEAEs were reported.
Time frame: Non-Hispanic Caucasians: 30 min pre-dose,1,4,8,24 h,32 days post-dose Japanese Descents: 30 min pre-dose,1,4,8,24 h post-dose on Days 1,4,7 and 32 days after last dose
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Results Reported as Treatment-emergent Adverse Events (TEAEs)
Twelve-lead ECGs were performed in triplicate at each time point. For numeric ECG variables, the mean of the valid values at each time point was taken. Number of participants with clinically significant changes in ECGs reported as TEAEs were reported.
Time frame: Non-Hispanic Caucasians: 30 min pre-dose,24 h,32 days post-dose Japanese Descents: 30 min pre-dose,24 h post-dose on Days 1,4,7 and 32 days after last dose
Number of Participants Who Reported Positive to Anti-Parathyroid Hormone Antibodies
Number of participants who reported positive to anti-parathyroid hormone antibodies were reported.
Time frame: Non-Hispanic Caucasians: 30 min pre-dose,32 days post-dose Japanese Descents: 30 min pre-dose on Days 1,4,7 and 32 days after last dose