Safety of a Hypolipidemic Agent in Healthy Normal Volunteers - Full Text View

Sponsored by:	Pharmena North America
Information provided by:	Pharmena North America
ClinicalTrials.gov Identifier:	NCT00685737

Purpose

The Purpose of this study is to determine the safety and tolerability of 1-MNA, a drug that is intended to be used in the treatment of elevated levels of blood fats. This study will determine the way that 1-MNA is handled by the body, and will also determine its effect on commonly measured blood fat parameters.

Condition	Intervention	Phase
Hyperlipidemia	Drug: 1-MNA Drug: Placebo	Phase I

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	A Randomized Placebo Controlled Double Blind Two Period Cross-Over Study to Assess the Safety and Pharmacokinetics and Pharmacodynamics of Oral Dosages of 1-MNA, (A Hypolipidemic Agent) in Healthy Volunteers

Further study details as provided by Pharmena North America:

Primary Outcome Measures:

The single dose pharmacokinetics and safety of 1-MNA and an assessment of any gender-based differences in plasma pharmacokinetics [ Time Frame: Over 24 hours following a dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The effect of 1-MNA on triglycerides and lipase activity and lipid profiles after single oral dosages [ Time Frame: Over 24 hours following a single dose ] [ Designated as safety issue: No ]

Enrollment:	20
Study Start Date:	December 2007
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 1-MNA-Low Dose	Drug: 1-MNA Capsule
2: Active Comparator 1-MNA-High Dose	Drug: 1-MNA Capsule
3: Placebo Comparator Placebo	Drug: Placebo Capsule

Detailed Description:

Dyslipidemia is a major risk factor for coronary artery disease (CAD) and its management is important in preventing the occurrence of cardiovascular events. Dyslipidemia occurs when there is an imbalance in the metabolism and clearance of lipoproteins resulting in lipoprotein overproduction or deficiency. Lipid related risk factors for atherosclerotic coronary artery disease include elevated levels of total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), intermediate-density lipoprotein cholesterol (IDL-C), very low-density lipoprotein cholesterol (VLDL-C) and reduced concentrations of high-density lipoprotein cholesterol (HDL-C). This lipid risk profile frequently occurs in association with other cardiovascular risk factors (e.g., obesity, elevated blood pressure, diabetes mellitus), and is associated with premature atherosclerosis (NCEP, 2002).

The Main purpose of this study is to formally evaluate the safety and pharmacokinetics and pharmacodynamics of 1-MNA, a hypolipidemic agent with previous human exposure in normal subjects and patients with Hyperlipidemia.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Good health (based on medical history, physical examination, electrocardiogram, and clinical laboratory tests)
Non-smokers (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the Screening visit)
Between 18 and 50 years old (inclusive)
Body weight within 20% of the desirable weight for adults at the Screening visit
Able to execute informed written consent (informed consent must be obtained for all subjects before enrollment in the study.
Willingness to abstain from alcohol and xanthine-containing food and beverages for the duration of each treatment period
Willingness to remain in the clinic for the inpatient portions of the study
Female subjects must be non-pregnant and either surgically sterile, postmenopausal for a least 1 year, or using an acceptable method of contraception defined as an oral, implanted, or transdermal contraceptive plus one of the following barrier methods: diaphragm with spermicidal cream/jelly or use of a condom by sexual partner.

Exclusion Criteria:

Currently abusing drugs or alcohol or with a history of drug or alcohol abuse within the past two years
Unwilling or unable to comply with the protocol or reside in the study unit during the study period or to cooperate fully with the principal investigator and site personnel
Has used any 1) prescription medication within 14 days prior to treatment in either treatment period or 2), or any over-the-counter (OTC) medication, herbal preparations, and/or vitamins within 48 hours prior to the start of study MNA administration on either treatment period of this study.
Has a clinically abnormal ECG
Has a serum potassium, sodium, calcium, or magnesium level that is not within normal limits or has other vital signs or clinical laboratory values at the screening visit that are deemed by the principal investigator to make the subject an inappropriate candidate for the study
Has taken any other investigational drug during the 30 days prior to screening visit
Has donated or lost more than a unit of blood within 30 days prior to screening visit
History of renal, hepatic, gastrointestinal, cardiovascular, or hematologic disease
Serious mental or physical illness within the past year
Has any condition(s) that in the investigator's opinion would: a) warrant exclusion from the study or b) prevent the subject from completing the study
Have a positive test for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody at screening
Be a female subject with a positive serum pregnancy test or who is breast-feeding at screening
Be unable to understand verbal and/or written English or any other language in which a certified translation of the informed consent is available
Has a history of hypersensitivity or allergic reaction to Niacin or Nicotinamide
Has had prior exposure to MNA
Has a Mental capacity that is limited to the extent that the subject cannot provide legal consent or understand information regarding the side effects or tolerance of the study drug.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685737

Locations

United States, New York
Buffalo Clinical Research Center
Buffalo, New York, United States, 14202

Sponsors and Collaborators

Pharmena North America

Investigators

Principal Investigator:

Charles H Ballow, Pharm D.

Buffalo Clinical Research Center

More Information

Responsible Party:	Buffalo Clinical Research Center ( Charles Ballow, Pharm D. FACCP )
Study ID Numbers:	PNAI-002
Study First Received:	May 23, 2008
Last Updated:	June 25, 2008
ClinicalTrials.gov Identifier:	NCT00685737
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pharmena North America:

Hyperlipidemia

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Healthy

Metabolic disorder
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009