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

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00464802

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 I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study
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 Wyeth:

Primary Outcome Measures:

IV site tolerability and urinary zinc excretion

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00464802

Locations

United States, Arizona

Phoenix, Arizona, United States, 85044

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	3200L2-1107
Study First Received:	April 23, 2007
Last Updated:	December 3, 2007
ClinicalTrials.gov Identifier:	NCT00464802
Health Authority:	United States: Food and Drug Administration

Keywords provided by Wyeth:

healthy
safety

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on January 16, 2009