Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers
Primary Purpose
Hyperparathyroidism, Secondary
Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Etelcalcetide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperparathyroidism, Secondary
Eligibility Criteria
Inclusion Criteria:
- Male between 18 and 45 years of age who have provided written informed consent
- Subject is judged to be in good health based on medical history, physical examination, and routine laboratory tests
Exclusion Criteria:
- History or presence of any significant acute or chronic illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease) according to the investigator
- History of any ongoing medical condition requiring treatment with prescription medication
- History of asthma, severe allergies including skin reactions or prior anaphylactic type reactions
- Clinically significant abnormalities on screening clinical examination or laboratory safety tests
- History of drug or alcohol abuse
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
Etelcalcetide
Arm Description
Participants received a single dose of placebo intravenous injection.
Participants received a single dose of etelcalcetide intravenous injection; the starting dose was 0.5 mg.
Outcomes
Primary Outcome Measures
Number of Participants With Adverse Events
Secondary Outcome Measures
Percent Change From Baseline in Serum Parathyroid Hormone
Percent Change From Baseline in Plasma Ionized Calcium
Change From Baseline in Serum Total Calcium
Change From Baseline in Serum Corrected Calcium
Change From Baseline in Serum Phosphate
Percent Change From Baseline in Serum Calcitonin
Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D
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.
Area Under the Concentration-time Curve Between the Time of Dose and the Last Time Point (AUCall) for Etelcalcetide
Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide
Percent Observed Area Under the Concentration-time Curve Extrapolated to Infinity Resulting From Extrapolation to Concentration of 0 ng/mL (AUC%Extrapobs)
Terminal Elimination Rate Constant (λz) for Etelcalcetide
Half-life Associated With the Terminal (Log-linear) Elimination Phase (HLλz) for Etelcalcetide
Total Body Clearance (CL) for Etelcalcetide
Volume of Distribution at Steady State for Etelcalcetide
Number of Participants With Antibodies to Etelcalcetide
Serum samples were analyzed for antibodies against etelcalcetide using a validated enzyme-linked immunosorbent assay (ELISA).
Full Information
NCT ID
NCT01134549
First Posted
May 28, 2010
Last Updated
February 28, 2017
Sponsor
KAI Pharmaceuticals
Collaborators
Nucleus Network Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01134549
Brief Title
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers
Official Title
A Double-Blind, Randomized, Placebo-Controlled, Rising Single Intravenous Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of KAI-4169 in Healthy Male Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
June 9, 2010 (undefined)
Primary Completion Date
July 31, 2010 (Actual)
Study Completion Date
July 31, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KAI Pharmaceuticals
Collaborators
Nucleus Network Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to characterize the safety and tolerability of etelcalcetide in healthy young males.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperparathyroidism, Secondary
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received a single dose of placebo intravenous injection.
Arm Title
Etelcalcetide
Arm Type
Experimental
Arm Description
Participants received a single dose of etelcalcetide intravenous injection; the starting dose was 0.5 mg.
Intervention Type
Drug
Intervention Name(s)
Etelcalcetide
Other Intervention Name(s)
KAI-4169, AMG 416, Parsabiv™
Intervention Description
Administered as a single intravenous (IV) injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered as a single intravenous (IV) injection
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Time Frame
From the first dose of study drug through 7 days.
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Serum Parathyroid Hormone
Time Frame
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
Title
Percent Change From Baseline in Plasma Ionized Calcium
Time Frame
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
Title
Change From Baseline in Serum Total Calcium
Time Frame
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
Title
Change From Baseline in Serum Corrected Calcium
Time Frame
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
Title
Change From Baseline in Serum Phosphate
Time Frame
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
Title
Percent Change From Baseline in Serum Calcitonin
Time Frame
Baseline and 10 minutes, 30 minutes, 3, 12, 24, and 48 hours post-dose
Title
Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D
Time Frame
Baseline and 12, 24, and 48 hours post-dose
Title
Maximum Observed Concentration (Cmax) for Etelcalcetide
Description
Plasma samples were analyzed for levels of etelcalcetide for pharmacokinetic (PK) analysis using a validated liquid chromatography/mass spectrometry (LC/MS) method.
Time Frame
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.
Title
Area Under the Concentration-time Curve Between the Time of Dose and the Last Time Point (AUCall) for Etelcalcetide
Time Frame
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.
Title
Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide
Time Frame
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.
Title
Percent Observed Area Under the Concentration-time Curve Extrapolated to Infinity Resulting From Extrapolation to Concentration of 0 ng/mL (AUC%Extrapobs)
Time Frame
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.
Title
Terminal Elimination Rate Constant (λz) for Etelcalcetide
Time Frame
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.
Title
Half-life Associated With the Terminal (Log-linear) Elimination Phase (HLλz) for Etelcalcetide
Time Frame
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.
Title
Total Body Clearance (CL) for Etelcalcetide
Time Frame
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.
Title
Volume of Distribution at Steady State for Etelcalcetide
Time Frame
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.
Title
Number of Participants With Antibodies to Etelcalcetide
Description
Serum samples were analyzed for antibodies against etelcalcetide using a validated enzyme-linked immunosorbent assay (ELISA).
Time Frame
Samples for antibody analysis were collected pre-dose and between days 7-12 and days 21-28.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male between 18 and 45 years of age who have provided written informed consent
Subject is judged to be in good health based on medical history, physical examination, and routine laboratory tests
Exclusion Criteria:
History or presence of any significant acute or chronic illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease) according to the investigator
History of any ongoing medical condition requiring treatment with prescription medication
History of asthma, severe allergies including skin reactions or prior anaphylactic type reactions
Clinically significant abnormalities on screening clinical examination or laboratory safety tests
History of drug or alcohol abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M D
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
City
Melbourne
State/Province
Victoria
Country
Australia
12. IPD Sharing Statement
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Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers
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