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Study Evaluating the Safety and Tolerability of a New Intravenous Formulation of MOA-728 in Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00464802
First Posted: April 24, 2007
Last Update Posted: July 26, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Valeant Pharmaceuticals International, Inc.
  Purpose
The primary objective is to determine the safety and tolerability of the new IV formulation versus the current formulation of MOA-728 focusing on the theoretical potential for infusion-related and formulation-related complications.

Condition Intervention Phase
Healthy Drug: MOA-728 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Multiple-Dose, 2-Period Crossover Study to Evaluate the Safety and Tolerability of a New Intravenous Formulation of MOA-728 in Comparison With the Current Formulation in Healthy Subjects

Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • IV site tolerability and urinary zinc excretion

Estimated Enrollment: 36
Study Start Date: April 2007
Study Completion Date: June 2007
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • A signed and dated informed consent form.
  • Men or nonlactating and nonpregnant women, aged 18 to 80 years, inclusive.
  • Women of nonchildbearing potential (WONCBP) must be surgically sterile (hysterectomy, oophorectomy, and/or tubal ligation) or postmenopausal for ³1 year.
  • Women of childbearing potential (WOCBP) must be using an acceptable nonhormonal method of contraception (intrauterine device [IUD], diaphragm, or condom with spermicidal jelly or foam, abstinence) for a period of at least 1 month before and after dose administration.
  • All women must have a negative pregnancy test result within 48 hours before the start of the first test article administration.
  • Body mass index in the range of 18 to 32 kg/m² and body weight ≥50 kg.
  • Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
  • Subjects aged 65 to 80 years should be healthy, but may be enrolled with a chronic illness, if such illness is well controlled and does not interfere with the primary objective of the study. Certain concomitant medications will be allowed for the treatment of these conditions and are listed in the Concomitant Treatment section.
  • Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking from 48 hours before and throughout the inpatient stay.
  • Have a high probability for compliance with and completion the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464802


Locations
United States, Arizona
Phoenix, Arizona, United States, 85044
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Jeff Cohn Valeant Pharmaceuticals International, Inc.
  More Information

Responsible Party: Jeff Cohn, Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00464802     History of Changes
Other Study ID Numbers: 3200L2-1107
First Submitted: April 23, 2007
First Posted: April 24, 2007
Last Update Posted: July 26, 2011
Last Verified: July 2011

Keywords provided by Valeant Pharmaceuticals International, Inc.:
healthy
safety