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Safety, Tolerability and Pharmacokinetics of KAI-4169 in Healthy Male Volunteers

This study has been completed.
Sponsor:
Collaborator:
Nucleus Network Ltd
Information provided by:
KAI Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01134549
First received: May 28, 2010
Last updated: August 20, 2010
Last verified: August 2010
History of Changes
  Purpose

The purpose of this study is to characterize the safety and tolerability of KAI-4169 in healthy young males.


Condition Intervention Phase
Hyperparathyroidism, Secondary
 Drug: KAI-4169
Drug: Saline
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Further study details as provided by KAI Pharmaceuticals:

Primary Outcome Measures:
  • Safety and tolerability of rising single doses of KAI-4169 by IV injection in healthy male subjects [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacodynamics of rising single doses of KAI-4169 by IV injection in healthy male subjects [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Pharmacokinetics of rising single doses of KAI-4169 by IV injection in healthy male subjects [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: June 2010
Study Completion Date: August 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Subjects will be randomly assigned to KAI-4169 or Placebo
 Drug: Saline
Single IV injection
Experimental: KAI-4169
Subjects will be randomly assigned to KAI-4169 or Placebo
 Drug: KAI-4169
Single IV injection 0.2, 2, 5, 10, 20, 40, or 60 mg

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01134549

Locations
Australia, Victoria
Melbourne, Victoria, Australia
Sponsors and Collaborators
KAI Pharmaceuticals
Nucleus Network Ltd
Investigators
Study Director: Gregory Bell, MD KAI Pharmaceuticals Inc.
  More Information

No publications provided

Responsible Party: Karen Pickthorn, Senior Director Clinical Development, KAI Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01134549     History of Changes
Other Study ID Numbers: KAI-4169-001
Study First Received: May 28, 2010
Last Updated: August 20, 2010
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by KAI Pharmaceuticals:
Phase 1 Clinical Trials

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 23, 2013