Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers
NCT ID: NCT01134549
Last Updated: 2017-04-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
32 participants
INTERVENTIONAL
2010-06-09
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Participants received a single dose of placebo intravenous injection.
Placebo
Administered as a single intravenous (IV) injection
Etelcalcetide
Participants received a single dose of etelcalcetide intravenous injection; the starting dose was 0.5 mg.
Etelcalcetide
Administered as a single intravenous (IV) injection
Interventions
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Etelcalcetide
Administered as a single intravenous (IV) injection
Placebo
Administered as a single intravenous (IV) injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subject is judged to be in good health based on medical history, physical examination, and routine laboratory tests
Exclusion Criteria
* 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
18 Years
45 Years
MALE
Yes
Sponsors
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Nucleus Network Ltd
OTHER
KAI Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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M D
Role: STUDY_DIRECTOR
Amgen
Locations
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Melbourne, Victoria, Australia
Countries
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Other Identifiers
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20130107
Identifier Type: OTHER
Identifier Source: secondary_id
KAI-4169-001
Identifier Type: -
Identifier Source: org_study_id
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