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

NCT ID: NCT00464802

Last Updated: 2019-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2007-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

MOA-728

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Salix Pharmaceuticals

Principal Investigators

Jeff Cohn

Role: STUDY_DIRECTOR

Bausch Health Americas, Inc.

Locations

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

3200L2-1107

Identifier Type: -

Identifier Source: org_study_id