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

NCT00464802 | Completed Phase 1

• 1 other identifier: 3200L2-1107
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

healthy; safety

Outcome Measures

Primary Outcomes (1)

• IV site tolerability and urinary zinc excretion

Interventions

MOA-728 DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (1)

Unknown Facility

Phoenix, Arizona, 85044, United States

Location

Study Officials

• Jeff Cohn

  Bausch Health Americas, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 24, 2007
• Study Start: April 1, 2007
• Study Completion: June 1, 2007
• Last Updated: November 25, 2019

Record last verified: 2019-11

Locations

US (1)