This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Valeant Pharmaceuticals International, Inc. Identifier:
First received: April 23, 2007
Last updated: July 22, 2011
Last verified: July 2011
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-Blind
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

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
  • 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
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00464802

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

Responsible Party: Jeff Cohn, Salix Pharmaceuticals Identifier: NCT00464802     History of Changes
Other Study ID Numbers: 3200L2-1107
Study First Received: April 23, 2007
Last Updated: July 22, 2011

Keywords provided by Valeant Pharmaceuticals International, Inc.:
safety processed this record on July 19, 2017