Phase 1
N=32
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers
Hyperparathyroidism, Secondary
Bottom Line
View on ClinicalTrials.gov: NCT01134549 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Number of Participants With Adverse Events — 2; 0; 1; 2 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- Etelcalcetide (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- KAI Pharmaceuticals
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
2; 0; 1; 2; 2; 0 | — |
| SECONDARY Percent Change From Baseline in Serum Parathyroid Hormone |
4.57; -20.58; -45.09; -59.38; -63.31; -3.52 | — |
| SECONDARY Percent Change From Baseline in Plasma Ionized Calcium |
-1.48; 0.98; -3.94; -5.30; -2.47; -1.27 | — |
| SECONDARY Change From Baseline in Serum Total Calcium |
-0.019; -0.008; -0.022; -0.017; -0.030; -0.018 | — |
| SECONDARY Change From Baseline in Serum Corrected Calcium |
-0.019; -0.008; -0.022; -0.017; -0.030; -0.018 | — |
| SECONDARY Change From Baseline in Serum Phosphate |
-0.033; 0.007; -0.065; -0.010; 0.022; -0.041 | — |
| SECONDARY Percent Change From Baseline in Serum Calcitonin |
15.92; 9.18; -5.07; 15.44; 51.45; 17.41 | — |
| SECONDARY Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D |
-14.46; -4.64; -6.12; -18.43; -25.60; -0.61 | — |
| SECONDARY Maximum Observed Concentration (Cmax) for Etelcalcetide |
43.5; 171; 280; 583 | — |
| SECONDARY Area Under the Concentration-time Curve Between the Time of Dose and the Last Time Point (AUCall) for Etelcalcetide |
81.1; 256; 544; 1130 | — |
| SECONDARY Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide |
94.3; 294; 623; 1290 | — |
| SECONDARY Percent Observed Area Under the Concentration-time Curve Extrapolated to Infinity Resulting From Extrapolation to Concentration of 0 ng/mL (AUC%Extrapobs) |
14.0; 13.2; 12.6; 12.0 | — |
| SECONDARY Terminal Elimination Rate Constant (λz) for Etelcalcetide |
0.0357; 0.0349; 0.0378; 0.0382 | — |
| SECONDARY Half-life Associated With the Terminal (Log-linear) Elimination Phase (HLλz) for Etelcalcetide |
19.5; 20.0; 18.6; 18.4 | — |
| SECONDARY Total Body Clearance (CL) for Etelcalcetide |
5.38; 6.87; 8.11; 7.83 | — |
| SECONDARY Volume of Distribution at Steady State for Etelcalcetide |
113; 138; 160; 152 | — |
| SECONDARY Number of Participants With Antibodies to Etelcalcetide |
0; 0; 0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT01134549). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.