Trial Outcomes & Findings for Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult Subjects (NCT NCT03150108)
NCT ID: NCT03150108
Last Updated: 2021-06-08
Results Overview
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 (%).
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
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
Results posted on
2021-06-08
Participant Flow
The study was conducted at a single center in United States between 19 April 2017 (first participant first visit) and 26 Jun 2017 (last participant last visit).
A total of 24 participants (12 non-Hispanic healthy volunteer Caucasian participants and 12 healthy Japanese participants) were enrolled and randomized to study treatment.
Participant milestones
| Measure |
Non-Hispanic Caucasians
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1, then followed by either 25 mcg or 50 mcg SC injection on Days 4 and 7 in a cross-over fashion. A washout period of 73 hours was maintained between each single doses (100 mcg, 50 mcg and 25 mcg).
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of rhPTH(1-84) in Japanese Healthy Subjects Compared With Matched Caucasian Healthy Adult Subjects
Baseline characteristics by cohort
| Measure |
Non-Hispanic Caucasians
n=12 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single SC injection of 100 mcg rhPTH\[1-84\] on Day 1.
|
Participants of Japanese Descent
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1, then followed by either 25 mcg or 50 mcg SC injection on Days 4 and 7 in a cross-over fashion. A washout period of 73 hours was maintained between each single doses (100 mcg, 50 mcg and 25 mcg).
|
Total
n=24 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
40.3 Years
STANDARD_DEVIATION 9.01 • n=5 Participants
|
41.3 Years
STANDARD_DEVIATION 10.40 • n=7 Participants
|
40.8 Years
STANDARD_DEVIATION 9.53 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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-dosePopulation: The pharmacokinetic (PK) set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value.
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 (%).
Outcome measures
| Measure |
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=12 Participants
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
|
Baseline-adjusted Cmax of PTH(1-84)
|
99.708 Picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 22.02
|
295.662 Picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 41.66
|
330.820 Picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 29.44
|
175.468 Picogram per milliliter (pg/mL)
Geometric Coefficient of Variation 35.29
|
PRIMARY outcome
Timeframe: 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-dosePopulation: The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value.
Baseline-adjusted time to reach maximum observed drug concentration (Tmax) of PTH(1-84) in plasma was reported.
Outcome measures
| Measure |
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=12 Participants
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
|
Baseline-adjusted Tmax of PTH(1-84)
|
1.240 Hour (h)
Interval 0.17 to 2.0
|
0.415 Hour (h)
Interval 0.17 to 3.0
|
1.000 Hour (h)
Interval 0.17 to 4.0
|
1.385 Hour (h)
Interval 0.5 to 2.5
|
PRIMARY outcome
Timeframe: 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-dosePopulation: The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value.
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 (%).
Outcome measures
| Measure |
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=12 Participants
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
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Baseline-adjusted AUC(Last) of PTH(1-84) in Plasma
|
255.67 Hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 28.7
|
1037.63 Hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 31.0
|
1027.81 Hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 32.6
|
602.06 Hour*picogram per milliliter (h*pg/mL)
Geometric Coefficient of Variation 30.6
|
PRIMARY outcome
Timeframe: 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-dosePopulation: The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value.
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 (%).
Outcome measures
| Measure |
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=12 Participants
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
|
Baseline-adjusted AUC(0-8) of PTH(1-84) in Plasma
|
248.38 h*pg/mL
Geometric Coefficient of Variation 19.7
|
956.63 h*pg/mL
Geometric Coefficient of Variation 32.8
|
1033.62 h*pg/mL
Geometric Coefficient of Variation 31.4
|
554.23 h*pg/mL
Geometric Coefficient of Variation 30.8
|
PRIMARY outcome
Timeframe: 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-dosePopulation: The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value. Here number of participants analyzed indicates the participants evaluable for this outcome.
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 (%).
Outcome measures
| Measure |
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=10 Participants
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)
n=8 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=10 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=9 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
|
Baseline-adjusted AUC(0-inf) of PTH(1-84) in Plasma
|
249.51 h*pg/mL
Geometric Coefficient of Variation 21.9
|
1028.29 h*pg/mL
Geometric Coefficient of Variation 37.0
|
1039.34 h*pg/mL
Geometric Coefficient of Variation 29.8
|
589.25 h*pg/mL
Geometric Coefficient of Variation 31.6
|
PRIMARY outcome
Timeframe: 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-dosePopulation: The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value. Here number of participants analyzed indicates the participants evaluable for this outcome.
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 (%).
Outcome measures
| Measure |
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=10 Participants
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)
n=8 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=10 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=9 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
|
Baseline- Adjusted % of AUC(0-Inf) Extra of PTH(1-84) in Plasma
|
3.015 Percentage of AUC
Geometric Coefficient of Variation 135.99
|
1.416 Percentage of AUC
Geometric Coefficient of Variation 198.59
|
0.932 Percentage of AUC
Geometric Coefficient of Variation 330.55
|
1.555 Percentage of AUC
Geometric Coefficient of Variation 173.86
|
PRIMARY outcome
Timeframe: 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-dosePopulation: The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value.
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 (%).
Outcome measures
| Measure |
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=10 Participants
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)
n=8 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=10 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=9 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
|
Baseline-adjusted Lambda_z of PTH(1-84) in Plasma
|
0.8277 Per hour (1/h)
Geometric Coefficient of Variation 57.118
|
0.4496 Per hour (1/h)
Geometric Coefficient of Variation 67.730
|
0.6672 Per hour (1/h)
Geometric Coefficient of Variation 35.835
|
0.5714 Per hour (1/h)
Geometric Coefficient of Variation 65.437
|
PRIMARY outcome
Timeframe: 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-dosePopulation: The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value. Here number of participants analyzed indicates the participants evaluable for this outcome.
Baseline-adjusted Terminal Half-life (t1/2) of PTH(1-84) in plasma was reported.
Outcome measures
| Measure |
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=10 Participants
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)
n=8 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=10 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=9 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
|
Baseline-adjusted t1/2 of PTH(1-84) in Plasma
|
0.950 Hour (h)
Interval 0.3 to 1.88
|
1.390 Hour (h)
Interval 0.68 to 4.74
|
1.060 Hour (h)
Interval 0.65 to 1.71
|
1.020 Hour (h)
Interval 0.69 to 3.57
|
PRIMARY outcome
Timeframe: 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-dosePopulation: The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value. Here number of participants analyzed indicates the participants evaluable for this outcome.
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 (%).
Outcome measures
| Measure |
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=10 Participants
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)
n=8 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=10 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=9 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
|
Baseline-adjusted CL/F of PTH(1-84) in Plasma
|
100.18 Liter per hour (L/h)
Geometric Coefficient of Variation 21.9
|
97.25 Liter per hour (L/h)
Geometric Coefficient of Variation 37.0
|
96.22 Liter per hour (L/h)
Geometric Coefficient of Variation 29.8
|
84.84 Liter per hour (L/h)
Geometric Coefficient of Variation 31.6
|
PRIMARY outcome
Timeframe: 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-dosePopulation: The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value. Here number of participants analyzed indicates the participants evaluable for this outcome.
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 (%).
Outcome measures
| Measure |
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=10 Participants
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)
n=8 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=10 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=9 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
|
Baseline-adjusted Vdz/F of PTH(1-84) in Plasma
|
121.02 Liters (L)
Geometric Coefficient of Variation 57.7
|
216.30 Liters (L)
Geometric Coefficient of Variation 93.9
|
144.18 Liters (L)
Geometric Coefficient of Variation 54.7
|
148.50 Liters (L)
Geometric Coefficient of Variation 71.9
|
SECONDARY outcome
Timeframe: 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-dosePopulation: The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value.
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 (%).
Outcome measures
| Measure |
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=12 Participants
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
|
Original Cmax of PTH(1-84) in Plasma
|
129.74 pg/mL
Geometric Coefficient of Variation 21.1
|
324.43 pg/mL
Geometric Coefficient of Variation 36.2
|
365.52 pg/mL
Geometric Coefficient of Variation 27.3
|
206.05 pg/mL
Geometric Coefficient of Variation 29.6
|
SECONDARY outcome
Timeframe: 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-dosePopulation: The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value.
The original time to reach maximum observed drug concentration (Tmax) of PTH(1-84) in plasma was reported.
Outcome measures
| Measure |
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=12 Participants
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
|
Original Tmax of PTH(1-84)
|
1.240 Hour (h)
Interval 0.17 to 2.0
|
0.415 Hour (h)
Interval 0.17 to 3.0
|
1.000 Hour (h)
Interval 0.17 to 4.0
|
1.385 Hour (h)
Interval 0.5 to 2.5
|
SECONDARY outcome
Timeframe: 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-dosePopulation: The PK set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PK concentration value.
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 (%).
Outcome measures
| Measure |
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=12 Participants
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
|
Original AUClast of PTH(1-84) in Plasma
|
959.49 h*pg/mL
Geometric Coefficient of Variation 26.1
|
1685.62 h*pg/mL
Geometric Coefficient of Variation 18.2
|
1823.70 h*pg/mL
Geometric Coefficient of Variation 23.7
|
1300.09 h*pg/mL
Geometric Coefficient of Variation 21.7
|
SECONDARY outcome
Timeframe: 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)Population: The pharmacodynamic (PD) set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PD concentration value.
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 (%).
Outcome measures
| Measure |
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=12 Participants
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
|
AUClast of Albumin-corrected Calcium, Serum Total Calcium and Phosphate Levels After Intake of PTH(1-84)
Albumin-corrected Calcium
|
52.61 Hours * millimoles per liter (h×mmol/L)
Geometric Coefficient of Variation 3.1
|
52.94 Hours * millimoles per liter (h×mmol/L)
Geometric Coefficient of Variation 2.5
|
53.22 Hours * millimoles per liter (h×mmol/L)
Geometric Coefficient of Variation 2.3
|
52.94 Hours * millimoles per liter (h×mmol/L)
Geometric Coefficient of Variation 2.5
|
|
AUClast of Albumin-corrected Calcium, Serum Total Calcium and Phosphate Levels After Intake of PTH(1-84)
Serum Total Calcium
|
53.62 Hours * millimoles per liter (h×mmol/L)
Geometric Coefficient of Variation 3.5
|
54.21 Hours * millimoles per liter (h×mmol/L)
Geometric Coefficient of Variation 2.7
|
54.62 Hours * millimoles per liter (h×mmol/L)
Geometric Coefficient of Variation 1.5
|
54.12 Hours * millimoles per liter (h×mmol/L)
Geometric Coefficient of Variation 2.6
|
|
AUClast of Albumin-corrected Calcium, Serum Total Calcium and Phosphate Levels After Intake of PTH(1-84)
Serum Phosphate
|
29.57 Hours * millimoles per liter (h×mmol/L)
Geometric Coefficient of Variation 7.6
|
27.21 Hours * millimoles per liter (h×mmol/L)
Geometric Coefficient of Variation 10.5
|
28.85 Hours * millimoles per liter (h×mmol/L)
Geometric Coefficient of Variation 10.2
|
28.60 Hours * millimoles per liter (h×mmol/L)
Geometric Coefficient of Variation 7.8
|
SECONDARY outcome
Timeframe: 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)Population: The PD set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PD concentration value.
The time to maximum effect (TEmax) of PTH(1-84) on albumin-corrected calcium, serum total calcium and serum phosphate levels were reported.
Outcome measures
| Measure |
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=12 Participants
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
|
TEmax After Intake of PTH(1-84) on Albumin-corrected Calcium, Serum Total Calcium and Serum Phosphate Levels
Albumin-corrected Calcium
|
4.000 Hour (h)
Interval 0.0 to 8.0
|
8.000 Hour (h)
Interval 4.0 to 12.02
|
8.000 Hour (h)
Interval 4.0 to 12.0
|
4.000 Hour (h)
Interval 0.0 to 8.0
|
|
TEmax After Intake of PTH(1-84) on Albumin-corrected Calcium, Serum Total Calcium and Serum Phosphate Levels
Serum Total Calcium
|
4.000 Hour (h)
Interval 0.0 to 12.02
|
8.000 Hour (h)
Interval 0.0 to 12.02
|
8.000 Hour (h)
Interval 4.0 to 12.0
|
8.000 Hour (h)
Interval 4.0 to 8.0
|
|
TEmax After Intake of PTH(1-84) on Albumin-corrected Calcium, Serum Total Calcium and Serum Phosphate Levels
Serum Phosphate
|
8.000 Hour (h)
Interval 0.0 to 12.02
|
8.010 Hour (h)
Interval 0.0 to 12.05
|
8.000 Hour (h)
Interval 4.0 to 11.98
|
8.000 Hour (h)
Interval 7.97 to 12.08
|
SECONDARY outcome
Timeframe: 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)Population: The PD set consisted of participants who received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable post-dose PD concentration value.
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 (%).
Outcome measures
| Measure |
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=12 Participants
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
|
Emax of PTH(1-84) on Albumin-corrected Calcium, Serum Total Calcium and Serum Phosphate Levels
Albumin-corrected Calcium
|
2.282 millimoles per liter (mmol/L)
Geometric Coefficient of Variation 2.34
|
2.287 millimoles per liter (mmol/L)
Geometric Coefficient of Variation 2.31
|
2.284 millimoles per liter (mmol/L)
Geometric Coefficient of Variation 2.46
|
2.283 millimoles per liter (mmol/L)
Geometric Coefficient of Variation 3.09
|
|
Emax of PTH(1-84) on Albumin-corrected Calcium, Serum Total Calcium and Serum Phosphate Levels
Serum Total Calcium
|
2.322 millimoles per liter (mmol/L)
Geometric Coefficient of Variation 2.02
|
2.359 millimoles per liter (mmol/L)
Geometric Coefficient of Variation 3.49
|
2.347 millimoles per liter (mmol/L)
Geometric Coefficient of Variation 1.83
|
2.330 millimoles per liter (mmol/L)
Geometric Coefficient of Variation 2.60
|
|
Emax of PTH(1-84) on Albumin-corrected Calcium, Serum Total Calcium and Serum Phosphate Levels
Serum Phosphate
|
1.383 millimoles per liter (mmol/L)
Geometric Coefficient of Variation 8.06
|
1.286 millimoles per liter (mmol/L)
Geometric Coefficient of Variation 11.88
|
1.325 millimoles per liter (mmol/L)
Geometric Coefficient of Variation 11.47
|
1.325 millimoles per liter (mmol/L)
Geometric Coefficient of Variation 7.94
|
SECONDARY outcome
Timeframe: From start of study drug administration to follow-up (up to 40 days)Population: The safety set included enrolled participants who received at least 1 dose of rhPTH(1-84).
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.
Outcome measures
| Measure |
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=12 Participants
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
3 Participants
|
4 Participants
|
6 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 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 dosePopulation: The safety set included enrolled participants who received at least 1 dose of rhPTH(1-84).
Clinical laboratory tests included hematology, chemistry, and urinalysis. Number of participants with clinically significant changes in clinical laboratory tests reported as TEAEs were reported.
Outcome measures
| Measure |
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=12 Participants
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Clinical Laboratory Tests Reported as Treatment-emergent Adverse Events (TEAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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 dosePopulation: The safety set included enrolled participants who received at least 1 dose of rhPTH(1-84).
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.
Outcome measures
| Measure |
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=12 Participants
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Signs Reported as Treatment-emergent Adverse Events (TEAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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 dosePopulation: The safety set included enrolled participants who received at least 1 dose of rhPTH(1-84).
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.
Outcome measures
| Measure |
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=12 Participants
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Results Reported as Treatment-emergent Adverse Events (TEAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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 dosePopulation: The safety set included enrolled participants who received at least 1 dose of rhPTH(1-84).
Number of participants who reported positive to anti-parathyroid hormone antibodies were reported.
Outcome measures
| Measure |
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=12 Participants
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
Non-Hispanic Caucasians: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (who have 2 non-Hispanic Caucasian parents and 4 non-Hispanic Caucasian grandparents) matched to participants of Japanese descent based on sex (1:1 male: female), age (+/-7 years), and body mass index (+/-15%) received a single subcutaneous (SC) injection of 100 microgram (mcg) recombinant human parathyroid hormone (rhPTH\[1-84\]) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=12 Participants
Participants (born in Japan, who have resided outside of Japan for no longer than 5 years and were of Japanese parentage, defined as having 2 Japanese parents, and 4 Japanese grandparents, all born in Japan) received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
|
Number of Participants Who Reported Positive to Anti-Parathyroid Hormone Antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Non-Hispanic Caucasians:100 mcg rhPTH(1- 84)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Non-Hispanic Caucasians:100 mcg rhPTH(1- 84)
n=12 participants at risk
Participants received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 100 mcg rhPTH(1-84)
n=12 participants at risk
Participants received a single SC injection of 100 mcg rhPTH(1-84) on Day 1.
|
Participants of Japanese Descent: 50 mcg rhPTH(1-84)
n=12 participants at risk
Participants received a single SC injection of 50 mcg rhPTH(1-84) on Day 4 or 7.
|
Participants of Japanese Descent: 25 mcg rhPTH(1-84)
n=12 participants at risk
Participants received a single SC injection of 25 mcg rhPTH(1-84) on Day 4 or 7.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
8.3%
1/12 • Number of events 1 • From start of study drug administration to follow-up (up to 40 days)
|
25.0%
3/12 • Number of events 3 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • Number of events 1 • From start of study drug administration to follow-up (up to 40 days)
|
8.3%
1/12 • Number of events 1 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
8.3%
1/12 • Number of events 1 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
|
Injury, poisoning and procedural complications
Sunburn
|
8.3%
1/12 • Number of events 1 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • Number of events 1 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
|
Nervous system disorders
Headache
|
8.3%
1/12 • Number of events 1 • From start of study drug administration to follow-up (up to 40 days)
|
25.0%
3/12 • Number of events 3 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
8.3%
1/12 • Number of events 1 • From start of study drug administration to follow-up (up to 40 days)
|
|
Nervous system disorders
Somnolence
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
8.3%
1/12 • Number of events 1 • From start of study drug administration to follow-up (up to 40 days)
|
8.3%
1/12 • Number of events 1 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
|
General disorders
Fatigue
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
8.3%
1/12 • Number of events 1 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
|
General disorders
Influenza like illness
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
8.3%
1/12 • Number of events 1 • From start of study drug administration to follow-up (up to 40 days)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
8.3%
1/12 • Number of events 1 • From start of study drug administration to follow-up (up to 40 days)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
0.00%
0/12 • From start of study drug administration to follow-up (up to 40 days)
|
8.3%
1/12 • Number of events 1 • From start of study drug administration to follow-up (up to 40 days)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER