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| ID | Type | Description | Link |
|---|---|---|---|
| 20130107 | Other Identifier | Amgen, Inc |
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| Name | Class |
|---|---|
| Nucleus Network Ltd | OTHER |
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The purpose of this study is to characterize the safety and tolerability of etelcalcetide in healthy young males.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants received a single dose of placebo intravenous injection. |
|
| Etelcalcetide | Experimental | Participants received a single dose of etelcalcetide intravenous injection; the starting dose was 0.5 mg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etelcalcetide | Drug | Administered as a single intravenous (IV) injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | From the first dose of study drug through 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Serum Parathyroid Hormone | Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose | |
| Percent Change From Baseline in Plasma Ionized Calcium | Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M D | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Melbourne | Victoria | Australia |
The study included 4 cohorts: 0.5 mg, 2 mg, 5 mg and 10 mg. Eight participants were enrolled into each cohort and were randomized 6:2 to receive etelcalcetide or placebo.
This study was conducted at one clinical center in Australia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pooled Placebo | Participants received a single dose of placebo administered by intravenous injection. |
| FG001 | Etelcalcetide 0.5 mg | Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection. |
| FG002 | Etelcalcetide 2 mg | Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection. |
| FG003 | Etelcalcetide 5 mg | Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection. |
| FG004 | Etelcalcetide 10 mg | Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pooled Placebo | Participants received a single dose of placebo administered by intravenous injection. |
| BG001 | Etelcalcetide 0.5 mg | Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | The modified intent-to-treat (MITT) population consisted of all participants who were randomized and received study medication. | Posted | Number | participants | From the first dose of study drug through 7 days. |
|
From the first dose of study drug through 7 days
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pooled Placebo | Participants received a single dose of placebo administered by intravenous injection. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen, Inc | 866-572-6436 |
Not provided
| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C583569 | etelcalcetide hydrochloride |
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| Placebo | Drug | Administered as a single intravenous (IV) injection |
|
| Change From Baseline in Serum Total Calcium | Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose |
| Change From Baseline in Serum Corrected Calcium | Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose |
| Change From Baseline in Serum Phosphate | Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose |
| Percent Change From Baseline in Serum Calcitonin | Baseline and 10 minutes, 30 minutes, 3, 12, 24, and 48 hours post-dose |
| Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D | Baseline and 12, 24, and 48 hours post-dose |
| Maximum Observed Concentration (Cmax) for Etelcalcetide | Plasma samples were analyzed for levels of etelcalcetide for pharmacokinetic (PK) analysis using a validated liquid chromatography/mass spectrometry (LC/MS) method. | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. |
| Area Under the Concentration-time Curve Between the Time of Dose and the Last Time Point (AUCall) for Etelcalcetide | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. |
| Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. |
| Percent Observed Area Under the Concentration-time Curve Extrapolated to Infinity Resulting From Extrapolation to Concentration of 0 ng/mL (AUC%Extrapobs) | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. |
| Terminal Elimination Rate Constant (λz) for Etelcalcetide | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. |
| Half-life Associated With the Terminal (Log-linear) Elimination Phase (HLλz) for Etelcalcetide | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. |
| Total Body Clearance (CL) for Etelcalcetide | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. |
| Volume of Distribution at Steady State for Etelcalcetide | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. |
| Number of Participants With Antibodies to Etelcalcetide | Serum samples were analyzed for antibodies against etelcalcetide using a validated enzyme-linked immunosorbent assay (ELISA). | Samples for antibody analysis were collected pre-dose and between days 7-12 and days 21-28. |
| BG002 | Etelcalcetide 2 mg | Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection. |
| BG003 | Etelcalcetide 5 mg | Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection. |
| BG004 | Etelcalcetide 10 mg | Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race | Count of Participants | Participants |
|
| Ethnicity | Count of Participants | Participants |
|
Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection. |
| OG003 | Etelcalcetide 5 mg | Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection. |
| OG004 | Etelcalcetide 10 mg | Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection. |
|
|
| Secondary | Percent Change From Baseline in Serum Parathyroid Hormone | Modified intent-to-treat population | Posted | Mean | Standard Deviation | percent change | Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose |
|
|
|
| Secondary | Percent Change From Baseline in Plasma Ionized Calcium | Modified intent-to-treat population | Posted | Mean | Standard Deviation | percent change | Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose |
|
|
|
| Secondary | Change From Baseline in Serum Total Calcium | Modified intent-to-treat population with available data at each time point | Posted | Mean | Standard Deviation | mmol/L | Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose |
|
|
|
| Secondary | Change From Baseline in Serum Corrected Calcium | Modified intent-to-treat population with available data at each time point | Posted | Mean | Standard Deviation | mmol/L | Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose |
|
|
|
| Secondary | Change From Baseline in Serum Phosphate | Modified intent-to-treat population with available data at each time point | Posted | Mean | Standard Deviation | mmol/L | Baseline and 10 minutes, 30 minutes, 1 hour, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 36, 42 and 48 hours post-dose |
|
|
|
| Secondary | Percent Change From Baseline in Serum Calcitonin | Modified intent-to-treat population | Posted | Mean | Standard Deviation | percent change | Baseline and 10 minutes, 30 minutes, 3, 12, 24, and 48 hours post-dose |
|
|
|
| Secondary | Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D | Modified intent-to-treat population | Posted | Mean | Standard Deviation | percent change | Baseline and 12, 24, and 48 hours post-dose |
|
|
|
| Secondary | Maximum Observed Concentration (Cmax) for Etelcalcetide | Plasma samples were analyzed for levels of etelcalcetide for pharmacokinetic (PK) analysis using a validated liquid chromatography/mass spectrometry (LC/MS) method. | Participants who received etelcalcetide | Posted | Mean | Standard Deviation | μg/L | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. |
|
|
|
| Secondary | Area Under the Concentration-time Curve Between the Time of Dose and the Last Time Point (AUCall) for Etelcalcetide | Participants who received etelcalcetide | Posted | Mean | Standard Deviation | hr*μg/L | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. |
|
|
|
| Secondary | Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide | Participants who received etelcalcetide | Posted | Mean | Standard Deviation | hr*μg/L | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. |
|
|
|
| Secondary | Percent Observed Area Under the Concentration-time Curve Extrapolated to Infinity Resulting From Extrapolation to Concentration of 0 ng/mL (AUC%Extrapobs) | Participants who received etelcalcetide | Posted | Mean | Standard Deviation | percentage of AUCINFobs | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. |
|
|
|
| Secondary | Terminal Elimination Rate Constant (λz) for Etelcalcetide | Participants who received etelcalcetide | Posted | Mean | Standard Deviation | 1/hr | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. |
|
|
|
| Secondary | Half-life Associated With the Terminal (Log-linear) Elimination Phase (HLλz) for Etelcalcetide | Participants who received etelcalcetide | Posted | Mean | Standard Deviation | hours | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. |
|
|
|
| Secondary | Total Body Clearance (CL) for Etelcalcetide | Participants who received etelcalcetide | Posted | Mean | Standard Deviation | L/hr | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. |
|
|
|
| Secondary | Volume of Distribution at Steady State for Etelcalcetide | Participants who received etelcalcetide | Posted | Mean | Standard Deviation | liters | Blood samples for PK assessment were drawn pre-dose, at 5, 10, 15, 20, and 30 minutes, post-dose, and at 1, 1.5, 2, 2.5, 3, 4, 6, 12, 24, 36, and 48 hours after drug administration. |
|
|
|
| Secondary | Number of Participants With Antibodies to Etelcalcetide | Serum samples were analyzed for antibodies against etelcalcetide using a validated enzyme-linked immunosorbent assay (ELISA). | Participants who received etelcalcetide | Posted | Count of Participants | Participants | Samples for antibody analysis were collected pre-dose and between days 7-12 and days 21-28. |
|
|
|
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | Etelcalcetide 0.5 mg | Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection. | 0 | 6 | 0 | 6 |
| EG002 | Etelcalcetide 2 mg | Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection. | 0 | 6 | 1 | 6 |
| EG003 | Etelcalcetide 5 mg | Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection. | 0 | 6 | 2 | 6 |
| EG004 | Etelcalcetide 10 mg | Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection. | 0 | 6 | 2 | 6 |
| EG005 | Etelcalcetide Pooled | Participants received a single dose of etelcalcetide administered by intravenous injection. | 0 | 24 | 5 | 24 |
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| FEELING HOT | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
|
| LETHARGY | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| PARAESTHESIA | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
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