Hyperparathyroidism, SecondaryPhase 1NCT01134549

Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers

A Phase 1 study testing Etelcalcetide in people with Hyperparathyroidism, Secondary, run by KAI Pharmaceuticals at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Hyperparathyroidism, Secondary
What is being tested?: Etelcalcetide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteAustralia
Study dates: 9 Jun 2010to 31 Jul 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Australia1 site

Study site
Melbourne, Victoria

Other trials in Australia

About this study

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

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

Conditions: Hyperparathyroidism, Secondary
Being tested: Etelcalcetide, Placebo
Medical subject headings: Hyperparathyroidism, Secondary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EtelcalcetideDrug
Also called KAI-4169, AMG 416, Parsabiv™
Administered as a single intravenous (IV) injection
PlaceboDrug
Administered as a single intravenous (IV) injection

Study groups in NCT01134549
Study group	Role	What they receive
Placebo	Placebo comparator	Participants received a single dose of placebo intravenous injection. Receives: Drug: Placebo
Etelcalcetide	Experimental	Participants received a single dose of etelcalcetide intravenous injection; the starting dose was 0.5 mg. Receives: Drug: Etelcalcetide

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Events
Measured: From the first dose of study drug through 7 days.

Secondary outcomes (16)

Percent Change From Baseline in Serum Parathyroid Hormone
Measured: 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 Plasma Ionized Calcium
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline and 10 minutes, 30 minutes, 3, 12, 24, and 48 hours post-dose
Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D
Measured: Baseline and 12, 24, and 48 hours post-dose
Maximum Observed Concentration (Cmax) for Etelcalcetide
Plasma samples were analyzed for levels of etelcalcetide for pharmacokinetic (PK) analysis using a validated liquid chromatography/mass spectrometry (LC/MS) method.
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Volume of Distribution at Steady State for Etelcalcetide
Measured: 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
Serum samples were analyzed for antibodies against etelcalcetide using a validated enzyme-linked immunosorbent assay (ELISA).
Measured: Samples for antibody analysis were collected pre-dose and between days 7-12 and days 21-28.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jun 201031 Jul 2010

First posted2 Jun 2010 (estimated)
Study start9 Jun 2010
Primary completion31 Jul 2010
Study completion31 Jul 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hyperparathyroidism, SecondaryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01134549
Sponsor's protocol ID: KAI-4169-001
Other IDs: 20130107
Status last verified: Feb 2017
First submitted: 28 May 2010
Last updated: 14 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Secondary Hyperparathyroidism, Chronic Kidney Disease
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REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
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Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism
Enrolling by invitationObservational study
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Renal Insufficiency,Chronic, Dietary Intake Patterns
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Osteoporosis & Renal Disease: Research in Primary Health Care Services
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All Hyperparathyroidism, Secondary trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01134549
Acronym / sponsor ID: KAI-4169-001
Conditions: Hyperparathyroidism, Secondary
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: KAI PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: Nucleus Network Ltd
Study start: 9 Jun 2010
Primary completion: 31 Jul 2010 (actual)
Study completion: 31 Jul 2010 (actual)
First posted: 2 Jun 2010 (estimated)
Results: Posted 14 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants received a single dose of placebo intravenous injection.
Etelcalcetide	Experimental	Drug: EtelcalcetideParticipants received a single dose of etelcalcetide intravenous injection; the starting dose was 0.5 mg.

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EtelcalcetideAlso: KAI-4169, AMG 416, Parsabiv™Administered as a single intravenous (IV) injection	Drug	Etelcalcetide
PlaceboAdministered as a single intravenous (IV) injection	Drug	Placebo

Primary outcome

Number of Participants With Adverse Events
Time frame: From the first dose of study drug through 7 days.

16 secondary outcomes

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
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
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
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
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
Percent Change From Baseline in Serum Calcitonin
Time frame: Baseline and 10 minutes, 30 minutes, 3, 12, 24, and 48 hours post-dose
Percent Change From Baseline in Serum 1,25 (OH)2 Vitamin D
Time frame: Baseline and 12, 24, and 48 hours post-dose
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.
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.
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.
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.
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.
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.
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.
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.
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.

Results and safety

Results posted to the registry on 14 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pooled Placebo	8	8
Etelcalcetide 0.5 mg	6	6
Etelcalcetide 2 mg	6	6
Etelcalcetide 5 mg	6	6
Etelcalcetide 10 mg	6	6

Primary outcome: Number of Participants With Adverse Events

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

Measure	Pooled Placebo n = 8	Etelcalcetide 2 mg n = 6	Etelcalcetide 5 mg n = 6	Etelcalcetide 10 mg n = 6
Any adverse event	2	1	2	2
Serious adverse events	0	0	0	0
Withdrawals due to adverse events	0	0	0	0
Treatment-related adverse events	0	1	1	1
Deaths	0	0	0	0

Population analysed: The modified intent-to-treat (MITT) population consisted of all participants who were randomized and received study medication.

16 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the first dose of study drug through 7 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pooled Placebo	0 of 8 (0%)	2 of 8 (25%)	Not reported
Etelcalcetide 0.5 mg	0 of 6 (0%)	0 of 6 (0%)	Not reported
Etelcalcetide 2 mg	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
Etelcalcetide 5 mg	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Etelcalcetide 10 mg	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Etelcalcetide Pooled	0 of 24 (0%)	5 of 24 (20.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hyperparathyroidism, Secondary

RecruitingPhase 3
Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
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Not yet recruitingPhase 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
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Not yet recruitingPhase 3
A Study of PLS240 in Pediatric Participants With Secondary Hyperparathyroidism and Chronic Kidney Disease on Hemodialysis
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Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

M D study director

Amgen

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Etelcalcetide in people with Hyperparathyroidism, Secondary, run by KAI Pharmaceuticals at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Events (time frame: From the first dose of study drug through 7 days.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01134549.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2017.