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Completed

NCT Number: NCT01134549

Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers

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

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Key information

Conditions

Hyperparathyroidism, Secondary Endocrine System Diseases Hyperparathyroidism Parathyroid Diseases

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Melbourne, Victoria, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Etelcalcetide

Drug

Administered as a single intravenous (IV) injection

Other names: KAI-4169, AMG 416, Parsabiv™

Placebo

Drug

Administered as a single intravenous (IV) injection

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: From the first dose of study drug through 7 days.

Secondary outcomes

  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).

Sponsors and collaborators

Lead sponsor

KAI Pharmaceuticals

Industry

Collaborators

  • Nucleus Network Ltd

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 2, 2010
Registry last updated
Apr 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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