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Trial record 70 of 97 for:    calcium cation

Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers

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ClinicalTrials.gov Identifier: NCT01134549
Recruitment Status : Completed
First Posted : June 2, 2010
Results First Posted : April 14, 2017
Last Update Posted : April 14, 2017
Sponsor:
Collaborator:
Nucleus Network Ltd
Information provided by (Responsible Party):
KAI Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Hyperparathyroidism, Secondary Drug: Etelcalcetide Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : June 9, 2010
Actual Primary Completion Date : July 31, 2010
Actual Study Completion Date : July 31, 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Participants received a single dose of placebo intravenous injection.
Drug: Placebo
Administered as a single intravenous (IV) injection

Experimental: Etelcalcetide
Participants received a single dose of etelcalcetide intravenous injection; the starting dose was 0.5 mg.
Drug: Etelcalcetide
Administered as a single intravenous (IV) injection
Other Names:
  • KAI-4169
  • AMG 416
  • Parsabiv™




Primary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: From the first dose of study drug through 7 days. ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]
  6. Percent Change From Baseline in Serum Calcitonin [ Time Frame: Baseline and 10 minutes, 30 minutes, 3, 12, 24, and 48 hours post-dose ]
  7. Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D [ Time Frame: Baseline and 12, 24, and 48 hours post-dose ]
  8. Maximum Observed Concentration (Cmax) 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. ]
    Plasma samples were analyzed for levels of etelcalcetide for pharmacokinetic (PK) analysis using a validated liquid chromatography/mass spectrometry (LC/MS) method.

  9. 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. ]
  10. 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. ]
  11. 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. ]
  12. 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. ]
  13. 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. ]
  14. 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. ]
  15. 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. ]
  16. Number of Participants With Antibodies to Etelcalcetide [ Time Frame: Samples for antibody analysis were collected pre-dose and between days 7-12 and days 21-28. ]
    Serum samples were analyzed for antibodies against etelcalcetide using a validated enzyme-linked immunosorbent assay (ELISA).



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01134549


Locations
Australia, Victoria
Melbourne, Victoria, Australia
Sponsors and Collaborators
KAI Pharmaceuticals
Nucleus Network Ltd
Investigators
Study Director: M D Amgen

Responsible Party: KAI Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01134549     History of Changes
Other Study ID Numbers: KAI-4169-001
20130107 ( Other Identifier: Amgen, Inc )
First Posted: June 2, 2010    Key Record Dates
Results First Posted: April 14, 2017
Last Update Posted: April 14, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases