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Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers

NCT01134549 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-04-14

Study results available
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Summary

The purpose of this study is to characterize the safety and tolerability of etelcalcetide in healthy young males.

Conditions

  • Hyperparathyroidism, Secondary

Interventions

DRUG

Etelcalcetide

Administered as a single intravenous (IV) injection

DRUG

Placebo

Administered as a single intravenous (IV) injection

Sponsors & Collaborators

  • Nucleus Network Ltd

    collaborator OTHER

  • KAI Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • M D · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-06-09
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01134549 on ClinicalTrials.gov