Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers

NCT01134549 | Completed Phase 1 Results

• 2 other identifiers: KAI-4169-00120130107
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperparathyroidism, Secondary

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  From the first dose of study drug through 7 days.

Secondary Outcomes (16)

• 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

• 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 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

• 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants received a single dose of placebo intravenous injection.

Drug: Placebo

Etelcalcetide

EXPERIMENTAL

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

Drug: Etelcalcetide

Interventions

Etelcalcetide DRUG

Administered as a single intravenous (IV) injection

Also known as: KAI-4169, AMG 416, Parsabiv™

Etelcalcetide

Placebo DRUG

Administered as a single intravenous (IV) injection

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• KAI Pharmaceuticals: lead
• Nucleus Network Ltd: collaborator

Study Sites (1)

Unknown Facility

Melbourne, Victoria, Australia

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Interventions

etelcalcetide hydrochloride

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Amgen, Inc

866-572-6436

Study Officials

• M D

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: June 2, 2010
• Study Start: June 9, 2010
• Primary Completion: July 31, 2010
• Study Completion: July 31, 2010
• Last Updated: April 14, 2017
• Results First Posted: April 14, 2017

Record last verified: 2017-02

Locations

AU (1)