Trial · NCT02781844
Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With Hypoparathyroidism
NCT02781844, Phase 1, Completed, Shire; results first posted 2020-04-09
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ConductScience Library. Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With Hypoparathyroidism. Trials, record NCT02781844. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02781844
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Participants With Hypoparathyroidism
- NCT number
- NCT02781844
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 34 participants, actual
- Lead sponsor
- Shire
- Conditions
- Hypoparathyroidism
- Interventions
- 25mcg rhPTH(1-84), 50mcg rhPTH(1-84), 100mcg rhPTH(1-84)
- First posted
- 2016-05-25
- Last updated
- 2021-05-25
- Other registries' IDs
- eudract:2015-004757-40
- Results first posted
- 2020-04-09
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time of Maximum Observed Concentration (Cmax) During a Dosing Interval (Tmax) of Baseline Adjusted rhPTH(1-84) | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose ; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. Tmax of baseline adjusted rhPTH(1-84) was reported. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. |
| Primary | Maximum Plasma Concentration (Cmax) of Baseline Adjusted rhPTH(1-84) | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. Cmax of baseline adjusted rhPTH(1-84) was reported. |
| Primary | Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Baseline Adjusted rhPTH(1-84) | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUClast of baseline adjsuted plasma rhPTH(1-84) was reported. |
| Primary | Area Under the Curve Extrapolated to Infinity (AUCinf) of Baseline Adjusted rhPTH(1-84) | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUCinf of baseline adjusted rhPTH(1-84) was reported. |
| Primary | Area Under the Concentration Curve From Time Zero to 24 Hours Post the First Dose (AUC0-24) of Baseline Adjusted rhPTH(1-84) | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24 hours post-dose | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUC0-24 of baseline adjusted rhPTH(1-84) was reported. |
| Primary | Area Under the Concentration Curve From Time Zero to 12 Hours Post the First Dose (AUC0-12) of Baseline Adjusted rhPTH(1-84) | BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours post-dose | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUC0-12 of baseline adjusted rhPTH(1-84) was reported. AUC(0-12) was planned, analyzed and reported only in participants who received BID treatment ( Treatment A, Treatment C, Treatment D, Treatment F). |
| Primary | Area Under the Concentration Curve From Time of the Second Dose to 12 Hours Post the Second Dose (AUC12-24) of Baseline Adjusted rhPTH(1-84) | BID: 12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24 hours post-dose | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. AUC12-24 of baseline adjusted rhPTH(1-84) was reported. AUC(12-24) was planned, analyzed and reported only in participants who received BID treatment ( Treatment A, Treatment C, Treatment D, Treatment F). |
| Primary | Terminal Half-Life (t1/2) of Baseline Adjusted rhPTH(1-84) | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose | Baseline-adjusted rhPTH(1-84) concentrations (participant- and period-specific) were calculated by subtracting baseline endogenous PTH from the raw PTH concentrations. The baseline was defined as premorning-dose endogenous rhPTH(1-84) level on Day 1 for each treatment period. T1/2 of baseline adjusted rhPTH(1-84) was reported. |
| Primary | Area Under the Concentration-Time Curve That is Above the Baseline, From Time 0 to 24 Hours (AUCabove) of Baseline-Adjusted Serum Calcium Concentrations on Day -1 | Day -1 | Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. AUCabove of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium \[uncorrected\]) concentrations on Day -1 was reported. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. |
| Primary | Area Under the Concentration-Time Curve That is Below the Baseline, From Time 0 to 24 Hours (AUCbelow) of Baseline-Adjusted Serum Calcium Concentrations on Day -1 | Day -1 | Baseline-adjusted concentrations calculated by subtracting the appropriate baseline values from the raw concentrations at each time point. AUCbelow of baseline-adjusted serum calcium (albumin-corrected) and total calcium (calcium \[uncorrected\]) concentrations on Day -1 was reported. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time of Maximum Observed Concentration (Cmax) During a Dosing Interval (Tmax) of Baseline Adjusted rhPTH(1-84) | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose ; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose | Pharmacokinetic (PK) analysis set consisted of all enrolled participants who did not have major protocol violations that affected the validity of the PK results, received at least 1 dose of rhPTH(1-84) and had at least 1 evaluable postdose PK concentration value available for 1 dose regimen. | hours | MEDIAN |
| PRIMARY | Maximum Plasma Concentration (Cmax) of Baseline Adjusted rhPTH(1-84) | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose | PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | picogram per milliliter (pg/mL) | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Curve From the Time of Dosing to the Last Measurable Concentration (AUClast) of Baseline Adjusted rhPTH(1-84) | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose | PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure and at specific category. | hour*picogram per milliliter (h*pg/mL) | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Curve Extrapolated to Infinity (AUCinf) of Baseline Adjusted rhPTH(1-84) | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose | PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure and at specific category. | h*pg/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration Curve From Time Zero to 24 Hours Post the First Dose (AUC0-24) of Baseline Adjusted rhPTH(1-84) | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24 hours post-dose | PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | h*pg/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration Curve From Time Zero to 12 Hours Post the First Dose (AUC0-12) of Baseline Adjusted rhPTH(1-84) | BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours post-dose | PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | h*pg/mL | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration Curve From Time of the Second Dose to 12 Hours Post the Second Dose (AUC12-24) of Baseline Adjusted rhPTH(1-84) | BID: 12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24 hours post-dose | PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | h*pg/mL | GEOMETRIC_MEAN |
| PRIMARY | Terminal Half-Life (t1/2) of Baseline Adjusted rhPTH(1-84) | QD: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12,16 and 24 hours post-dose; BID: Pre-dose,10,20,30 minutes,1,1.5,2,4,8,12 hours,12 hour 10 minutes,12 hour 20 minutes,12 hour 30 minutes,13 hours, 13 hour 30 minutes,14,16,20,22,24,28 and 36 hours post-dose | PK analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure and at specific category. | hours | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration-Time Curve That is Above the Baseline, From Time 0 to 24 Hours (AUCabove) of Baseline-Adjusted Serum Calcium Concentrations on Day -1 | Day -1 | Pharmacodynamic (PD) analysis set consisted of all enrolled participants who did not have major protocol violations that affected the validity of the PD results, received at least 1 dose of rhPTH(1 84) and had at least 1 evaluable post-dose PD value available for 1 dose regimen. | hour*millimoles per Liter (h*mmol/L) | MEAN |
| PRIMARY | Area Under the Concentration-Time Curve That is Below the Baseline, From Time 0 to 24 Hours (AUCbelow) of Baseline-Adjusted Serum Calcium Concentrations on Day -1 | Day -1 | PD analysis set. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | h*mmol/L | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group170
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time of Maximum Observed Concentration (Cmax) During a Dosing Interval (Tmax) of Baseline Adjusted rhPTH(1-84) | Cohort I: Treatment A | 7.108 | Full Range 0.18 to 14.07 | hours | |
| Time of Maximum Observed Concentration (Cmax) During a Dosing Interval (Tmax) of Baseline Adjusted rhPTH(1-84) | Cohort II: Treatment C | 7.083 | Full Range 0.17 to 13.50 | hours | |
| Time of Maximum Observed Concentration (Cmax) During a Dosing Interval (Tmax) of Baseline Adjusted rhPTH(1-84) | Cohort I+II: Treatment B | 0.333 | Full Range 0.17 to 4.17 | hours | |
| Time of Maximum Observed Concentration (Cmax) During a Dosing Interval (Tmax) of Baseline Adjusted rhPTH(1-84) | Cohort III: Treatment D | 1.000 | Full Range 0.15 to 14.00 | hours | |
| Time of Maximum Observed Concentration (Cmax) During a Dosing Interval (Tmax) of Baseline Adjusted rhPTH(1-84) | Cohort IV: Treatment F | 12.167 | Full Range 0.17 to 13.50 | hours | |
| Time of Maximum Observed Concentration (Cmax) During a Dosing Interval (Tmax) of Baseline Adjusted rhPTH(1-84) | Cohort III + IV: Treatment E | 0.667 | Full Range 0.12 to 4.00 | hours | |
| Maximum Plasma Concentration (Cmax) of Baseline Adjusted rhPTH(1-84) | Cohort I: Treatment A | 136.9 | Geometric Coefficient of Variation 50.9 | picogram per milliliter (pg/mL) | |
| Maximum Plasma Concentration (Cmax) of Baseline Adjusted rhPTH(1-84) | Cohort II: Treatment C | 213.6 | Geometric Coefficient of Variation 51.6 | picogram per milliliter (pg/mL) | |
| Maximum Plasma Concentration (Cmax) of Baseline Adjusted rhPTH(1-84) | Cohort I+II: Treatment B | 339.1 | Geometric Coefficient of Variation 137.8 | picogram per milliliter (pg/mL) | |
| Maximum Plasma Concentration (Cmax) of Baseline Adjusted rhPTH(1-84) | Cohort III: Treatment D | 120.9 | Geometric Coefficient of Variation 83.6 | picogram per milliliter (pg/mL) |
1 to 10 of 170Source ClinicalTrials.gov
See all 170 results by groupParticipant flow48
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period 1 | STARTED | Cohort I: Treatment A / B | 5 | |
| Treatment Period 1 | STARTED | Cohort I: Treatment B / A | 4 | |
| Treatment Period 1 | STARTED | Cohort II: Treatment C / B | 4 | |
| Treatment Period 1 | STARTED | Cohort II: Treatment B / C | 4 | |
| Treatment Period 1 | STARTED | Cohort III: Treatment D / E | 4 | |
| Treatment Period 1 | STARTED | Cohort III: Treatment E / D | 5 | |
| Treatment Period 1 | STARTED | Cohort IV: Treatment F / E | 4 | |
| Treatment Period 1 | STARTED | Cohort IV: Treatment E / F | 4 | |
| Treatment Period 1 | COMPLETED | Cohort I: Treatment A / B | 5 | |
| Treatment Period 1 | COMPLETED | Cohort I: Treatment B / A | 4 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 participant flowAdverse events180
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Cohort I: Treatment A | 0 | 9 | 0 |
| other | Nausea | Gastrointestinal disorders | Cohort II: Treatment C | 0 | 8 | 0 |
| other | Nausea | Gastrointestinal disorders | Cohort I+II: Treatment B | 3 | 17 | 3 |
| other | Nausea | Gastrointestinal disorders | Cohort III: Treatment D | 1 | 8 | 1 |
| other | Nausea | Gastrointestinal disorders | Cohort IV: Treatment F | 2 | 8 | 2 |
| other | Nausea | Gastrointestinal disorders | Cohort III + IV: Treatment E | 1 | 17 | 1 |
| other | Abdominal pain upper | Gastrointestinal disorders | Cohort I: Treatment A | 0 | 9 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Cohort II: Treatment C | 0 | 8 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Cohort I+II: Treatment B | 0 | 17 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Cohort III: Treatment D | 0 | 8 | 0 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort I: Treatment A | 0 | 9 |
| Total, all-cause mortality | Cohort II: Treatment C | 0 | 8 |
| Total, all-cause mortality | Cohort I+II: Treatment B | 0 | 17 |
| Total, all-cause mortality | Cohort III: Treatment D | 0 | 8 |
| Total, all-cause mortality | Cohort IV: Treatment F | 0 | 8 |
| Total, all-cause mortality | Cohort III + IV: Treatment E | 0 | 17 |
| Total, other adverse events | Cohort I: Treatment A | 3 | 9 |
| Total, other adverse events | Cohort II: Treatment C | 1 | 8 |
| Total, other adverse events | Cohort I+II: Treatment B | 4 | 17 |
| Total, other adverse events | Cohort III: Treatment D | 5 | 8 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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