| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | | Safety population included all participants who received at least 1 minute of study drug infusion (pre-amendment and post-amendment). | Posted | | Number | | participants | | From Day 1 up to safety follow-up assessment (upto Day 17 after discharge) | | | | ID | Title | Description |
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| OG000 | NPSP795 | NPSP795 administered Intravenous (IV) infusion for 10 min on Day 1 if certain criteria for ionized calcium and/or blood parathyroid hormone (PTH) were met, an infusion was administered for either 10 min or 3.5 hours on Days 2 & 3, according to a predefined dose escalation scheme. NPSP795 was administered as a 3.5-hour infusion on Day 4, or the participant underwent discharge procedures. |
| | | Title | Denominators | Categories |
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| Participants with TEAEs | | | | Participants with TESAEs | | |
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| Primary | Number of Participants With Clinically Significant Vital Signs and Electrocardiogram (ECG) Abnormalities | | Safety population included all participants who received at least 1 minute of study drug infusion (both pre-amendment and post-amendment participants). | Posted | | Number | | participants | | From Day 1 up to safety follow-up assessment (upto Day 17 after discharge) | | | | ID | Title | Description |
|---|
| OG000 | NPSP795 | NPSP795 administered Intravenous (IV) infusion for 10 min on Day 1 if certain criteria for ionized calcium and/or blood parathyroid hormone (PTH) were met, an infusion was administered for either 10 min or 3.5 hours on Days 2 & 3, according to a predefined dose escalation scheme. NPSP795 was administered as a 3.5-hour infusion on Day 4, or the participant underwent discharge procedures. |
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| Primary | Number of Participants With Potentially Clinically Important Laboratory Abnormalities | | Safety population included all participants who received at least 1 minute of study drug infusion (pre-amendment and post-amendment). | Posted | | Number | | participants | | From Day 1 up to safety follow-up assessment (upto Day 17 after discharge) | | | | ID | Title | Description |
|---|
| OG000 | NPSP795 | NPSP795 administered Intravenous (IV) infusion for 10 min on Day 1 if certain criteria for ionized calcium and/or blood parathyroid hormone (PTH) were met, an infusion was administered for either 10 min or 3.5 hours on Days 2 & 3, according to a predefined dose escalation scheme. NPSP795 was administered as a 3.5-hour infusion on Day 4, or the participant underwent discharge procedures. |
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| Primary | Number of Participants With Clinically Significant Abnormalities Related to Physical Examination | | Safety population included all participants who received at least 1 minute of study drug infusion (both pre-amendment and post-amendment participants). | Posted | | Number | | participants | | From Day 1 up to safety follow-up assessment (upto Day 17 after discharge) | | | | ID | Title | Description |
|---|
| OG000 | NPSP795 | NPSP795 administered Intravenous (IV) infusion for 10 min on Day 1 if certain criteria for ionized calcium and/or blood parathyroid hormone (PTH) were met, an infusion was administered for either 10 min or 3.5 hours on Days 2 & 3, according to a predefined dose escalation scheme. NPSP795 was administered as a 3.5-hour infusion on Day 4, or the participant underwent discharge procedures. |
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| Primary | Change From Baseline in Ionised Calcium | | Post-amendment pharmacodynamic (PD) analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively. | Posted | | Mean | Standard Deviation | millimole/liter (mmol/L) | | 10 Minute (min) Infusion Time: within 5 min pre-dose; & post-dose 15, 30, 45, 60, 75, 90, 105 min, and 2, 2.5, 3, 3.5, & 4 hour (hr) 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30, 45, 60, 75, 90, 105 min, & 2, 2.5, 3, 3.5, 4, 5, and 8 hr | | | | ID | Title | Description |
|---|
| OG000 | NPSP795 on Day 1 (5 mg/10 Minutes) | | | OG001 | NPSP795 on Day 2 (15 mg/3.5 Hours) | | | OG002 | NPSP795 on Day 3 (30 mg/3.5 Hours) | | | OG003 | NPSP795 on Day 4 (30 mg/3.5 Hours) | | | OG004 | NPSP795 on Day 4 (50 mg/3.5 Hours) | |
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| Primary | Change From Baseline in Serum Calcium | | Post-amendment PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively. | Posted | | Mean | Standard Deviation | millimole/liter (mmol/L) | | 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hr. | | | | ID | Title | Description |
|---|
| OG000 | NPSP795 on Day 1 (5 mg/10 Minutes) | | | OG001 | NPSP795 on Day 2 (15 mg/3.5 Hours) | | | OG002 | NPSP795 on Day 3 (30 mg/3.5 Hours) | | | OG003 | NPSP795 on Day 4 (30 mg/3.5 Hours) | | | OG004 | NPSP795 on Day 4 (50 mg/3.5 Hours) | |
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| Primary | Change From Baseline in Urinary Calcium | | PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively. | Posted | | Mean | Standard Deviation | millimole/liter (mmol/L) | | 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8 12 hr. | | | | ID | Title | Description |
|---|
| OG000 | NPSP795 on Day 1 (5 mg/10 Minutes) | | | OG001 | NPSP795 on Day 2 (15 mg/3.5 Hours) | | | OG002 | NPSP795 on Day 3 (30 mg/3.5 Hours) | | | OG003 | NPSP795 on Day 4 (30 mg/3.5 Hours) | | | OG004 | NPSP795 on Day 4 (50 mg/3.5 Hours) | |
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| Primary | Change From Baseline in Serum Parathyroid Hormone (PTH) | | Post amendment PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here, n=number of participants analysed for specified category at the specified time points in each arm respectively. | Posted | | Mean | Standard Deviation | nanogram/liter (ng/L) | | 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr | | | | ID | Title | Description |
|---|
| OG000 | NPSP795 on Day 1 (5 mg/10 Minutes) | | | OG001 | NPSP795 on Day 2 (15 mg/3.5 Hours) | | | OG002 | NPSP795 on Day 3 (30 mg/3.5 Hours) | | | OG003 | NPSP795 on Day 4 (30 mg/3.5 Hours) | | | OG004 | NPSP795 on Day 4 (50 mg/3.5 Hours) | |
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| Secondary | Area Under the Plasma Concentration Versus Time Curve (AUC[0-t]) of NPSP795 | | Post amendment pharmacokinetic (PK) analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least 1 day of infusion. | Posted | | Mean | Standard Deviation | nanogram*hour per millilitre (ng·h/mL) | | 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr | | | | ID | Title | Description |
|---|
| OG000 | NPSP795 on Day 1 (5 mg/10 Minutes) | | | OG001 | NPSP795 on Day 2 (15 mg/3.5 Hours) | | | OG002 | NPSP795 on Day 3 (30 mg/3.5 Hours) | | | OG003 | NPSP795 on Day 4 (30 mg/3.5 Hours) | | | OG004 | NPSP795 on Day 4 (50 mg/3.5 Hours) | |
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| Secondary | Area Under the Concentration Time Curve Extrapolated to Infinity (AUC0-infinity) of NPSP795 | | Post amendment PK analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least 1 day of infusion. | Posted | | Mean | Standard Deviation | nanogram*hour per milliliter(ng·h/mL) | | 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr | | | | ID | Title | Description |
|---|
| OG000 | NPSP795 on Day 1 (5 mg/10 Minutes) | | | OG001 | NPSP795 on Day 2 (15 mg/3.5 Hours) | | | OG002 | NPSP795 on Day 3 (30 mg/3.5 Hours) | | | OG003 | NPSP795 on Day 4 (30 mg/3.5 Hours) | | | OG004 | NPSP795 on Day 4 (50 mg/3.5 Hours) | |
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| Secondary | Maximum Observed Drug Concentration (Cmax) of NPSP795 in Plasma | | Post amendment PK analysis population included all randomized participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least one day of infusion. | Posted | | Mean | Standard Deviation | nanogram/milliliter (ng/mL) | | 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr | | | | ID | Title | Description |
|---|
| OG000 | NPSP795 on Day 1 (5 mg/10 Minutes) | | | OG001 | NPSP795 on Day 2 (15 mg/3.5 Hours) | | | OG002 | NPSP795 on Day 3 (30 mg/3.5 Hours) | | | OG003 | NPSP795 on Day 4 (30 mg/3.5 Hours) | | | OG004 | NPSP795 on Day 4 (50 mg/3.5 Hours) | |
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| Secondary | Elimination Half-life (t1/2) of NPSP795 in Plasma | | Post amendment PK analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PK measurement on at least 1 day of infusion. | Posted | | Mean | Standard Deviation | hour | | 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 5, 10, 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 8 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 15, 30 min, & 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 5.5 hr | | | | ID | Title | Description |
|---|
| OG000 | NPSP795 on Day 1 (5 mg/10 Minutes) | | | OG001 | NPSP795 on Day 2 (15 mg/3.5 Hours) | | | OG002 | NPSP795 on Day 3 (30 mg/3.5 Hours) | | | OG003 | NPSP795 on Day 4 (30 mg/3.5 Hours) | | | OG004 | NPSP795 on Day 4 (50 mg/3.5 Hours) | |
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| Secondary | Change From Baseline in Fractional Excretion of Calcium (FECa) | | Post-amendment PD analysis population included all participants who received at least 5 minutes of the study drug infusion and had at least one PD measurement on at least 1 day of infusion. Here n=number of participants analysed for specified category at the specified time points in each arm respectively. | Posted | | Mean | Standard Deviation | Fraction of excretion | | 10 Minutes (min) Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8, 12 hours (hr). 3.5 hr Infusion Time: within 5 min pre-dose; & post-dose 1, 2, 3, 4, 8, 12 hr. | | | | ID | Title | Description |
|---|
| OG000 | NPSP795 on Day 1 (5 mg/10 Minutes) | | | OG001 | NPSP795 on Day 2 (15 mg/3.5 Hours) | | | OG002 | NPSP795 on Day 3 (30 mg/3.5 Hours) | | | OG003 | NPSP795 on Day 4 (30 mg/3.5 Hours) | | | OG004 | NPSP795 on Day 4 (50 mg/3.5 Hours) | |
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