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

KAI Pharmaceuticals0 sites32 target enrollmentJune 9, 2010

ConditionsHyperparathyroidism, Secondary

InterventionsPlacebo Etelcalcetide

DrugsEtelcalcetide Placebo

Overview

Phase: Phase 1
Intervention: Placebo
Conditions: Hyperparathyroidism, Secondary
Sponsor: KAI Pharmaceuticals
Enrollment: 32
Primary Endpoint: Number of Participants With Adverse Events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

June 9, 2010

End Date

July 31, 2010

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

KAI Pharmaceuticals

Responsible Party

Sponsor

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

Arms & Interventions

Placebo

Participants received a single dose of placebo intravenous injection.

Intervention: Placebo

Etelcalcetide

Participants received a single dose of etelcalcetide intravenous injection; the starting dose was 0.5 mg.

Intervention: Etelcalcetide

Outcomes

Primary Outcomes

Number of Participants With Adverse Events

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

Secondary Outcomes

Percent Change From Baseline in Serum Parathyroid Hormone(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)
Change From Baseline in Serum Corrected Calcium(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)
Percent Change From Baseline in Serum Calcitonin(Baseline and 10 minutes, 30 minutes, 3, 12, 24, and 48 hours post-dose)
Percent Change From Baseline in Plasma Ionized Calcium(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)
Change From Baseline in Serum Total Calcium(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)
Change From Baseline in Serum Phosphate(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)
Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D(Baseline and 12, 24, and 48 hours post-dose)
Maximum Observed Concentration (Cmax) for Etelcalcetide(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.)
Area Under the Concentration-time Curve Between the Time of Dose and the Last Time Point (AUCall) for Etelcalcetide(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.)
Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide(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.)
Percent Observed Area Under the Concentration-time Curve Extrapolated to Infinity Resulting From Extrapolation to Concentration of 0 ng/mL (AUC%Extrapobs)(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.)
Terminal Elimination Rate Constant (λz) for Etelcalcetide(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.)
Half-life Associated With the Terminal (Log-linear) Elimination Phase (HLλz) for Etelcalcetide(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.)
Total Body Clearance (CL) for Etelcalcetide(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.)
Number of Participants With Antibodies to Etelcalcetide(Samples for antibody analysis were collected pre-dose and between days 7-12 and days 21-28.)
Volume of Distribution at Steady State for Etelcalcetide(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.)