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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01134549




Registration number
NCT01134549
Ethics application status
Date submitted
28/05/2010
Date registered
2/06/2010
Date last updated
14/04/2017

Titles & IDs
Public title
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers
Scientific 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
Secondary ID [1] 0 0
20130107
Secondary ID [2] 0 0
KAI-4169-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hyperparathyroidism, Secondary 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Etelcalcetide
Treatment: Drugs - Placebo

Placebo Comparator: Placebo - Participants received a single dose of placebo intravenous injection.

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


Treatment: Drugs: Etelcalcetide
Administered as a single intravenous (IV) injection

Treatment: Drugs: Placebo
Administered as a single intravenous (IV) injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events
Timepoint [1] 0 0
From the first dose of study drug through 7 days.
Secondary outcome [1] 0 0
Percent Change From Baseline in Serum Parathyroid Hormone
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
Percent Change From Baseline in Plasma Ionized Calcium
Timepoint [2] 0 0
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
Secondary outcome [3] 0 0
Change From Baseline in Serum Total Calcium
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Change From Baseline in Serum Corrected Calcium
Timepoint [4] 0 0
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
Secondary outcome [5] 0 0
Change From Baseline in Serum Phosphate
Timepoint [5] 0 0
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
Secondary outcome [6] 0 0
Percent Change From Baseline in Serum Calcitonin
Timepoint [6] 0 0
Baseline and 10 minutes, 30 minutes, 3, 12, 24, and 48 hours post-dose
Secondary outcome [7] 0 0
Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D
Timepoint [7] 0 0
Baseline and 12, 24, and 48 hours post-dose
Secondary outcome [8] 0 0
Maximum Observed Concentration (Cmax) for Etelcalcetide
Timepoint [8] 0 0
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.
Secondary outcome [9] 0 0
Area Under the Concentration-time Curve Between the Time of Dose and the Last Time Point (AUCall) for Etelcalcetide
Timepoint [9] 0 0
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.
Secondary outcome [10] 0 0
Observed Area Under the Concentration-time Curve Extrapolated to Infinity (AUCINFobs) for Etelcalcetide
Timepoint [10] 0 0
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.
Secondary outcome [11] 0 0
Percent Observed Area Under the Concentration-time Curve Extrapolated to Infinity Resulting From Extrapolation to Concentration of 0 ng/mL (AUC%Extrapobs)
Timepoint [11] 0 0
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.
Secondary outcome [12] 0 0
Terminal Elimination Rate Constant (?z) for Etelcalcetide
Timepoint [12] 0 0
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.
Secondary outcome [13] 0 0
Half-life Associated With the Terminal (Log-linear) Elimination Phase (HL?z) for Etelcalcetide
Timepoint [13] 0 0
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.
Secondary outcome [14] 0 0
Total Body Clearance (CL) for Etelcalcetide
Timepoint [14] 0 0
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.
Secondary outcome [15] 0 0
Volume of Distribution at Steady State for Etelcalcetide
Timepoint [15] 0 0
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.
Secondary outcome [16] 0 0
Number of Participants With Antibodies to Etelcalcetide
Timepoint [16] 0 0
Samples for antibody analysis were collected pre-dose and between days 7-12 and days 21-28.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/06/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/07/2010
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
KAI Pharmaceuticals
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Nucleus Network Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to characterize the safety and tolerability of etelcalcetide in
healthy young males.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01134549
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
M D
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01134549