Clinical trial NCT01134549: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hyperparathyroidism, Secondary
Lead sponsor: KAI Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Nucleus Network Ltd
First posted: 2010-06-02
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From the first dose of study drug through 7 days.
Secondary outcomes:
measure: Percent Change From Baseline in Serum Parathyroid Hormone
timeFrame: 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
measure: Percent Change From Baseline in Plasma Ionized Calcium
timeFrame: 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
measure: Change From Baseline in Serum Total Calcium
timeFrame: 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
measure: Change From Baseline in Serum Corrected Calcium
timeFrame: 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
measure: Change From Baseline in Serum Phosphate
timeFrame: 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
measure: Percent Change From Baseline in Serum Calcitonin
timeFrame: Baseline and 10 minutes, 30 minutes, 3, 12, 24, and 48 hours post-dose
measure: Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D
timeFrame: Baseline and 12, 24, and 48 hours post-dose
measure: Maximum Observed Concentration (Cmax) for Etelcalcetide
timeFrame: 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.
measure: Area Under the Concentration-time Curve Between the Time of Dose and the Last Time Point (AUCall) for Etelcalcetide
timeFrame: 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.
measure: Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide
timeFrame: 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.
measure: Percent Observed Area Under the Concentration-time Curve Extrapolated to Infinity Resulting From Extrapolation to Concentration of 0 ng/mL (AUC%Extrapobs)
timeFrame: 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.
measure: Terminal Elimination Rate Constant (λz) for Etelcalcetide
timeFrame: 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.
measure: Half-life Associated With the Terminal (Log-linear) Elimination Phase (HLλz) for Etelcalcetide
timeFrame: 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.
measure: Total Body Clearance (CL) for Etelcalcetide
timeFrame: 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.
measure: Volume of Distribution at Steady State for Etelcalcetide
timeFrame: 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.
measure: Number of Participants With Antibodies to Etelcalcetide
timeFrame: Samples for antibody analysis were collected pre-dose and between days 7-12 and days 21-28.
Other outcomes:
Locations:
city: Melbourne
country: Australia
state: Victoria
Study officials:
affiliation: Amgen
name: M D
role: STUDY_DIRECTOR
References: