Safety of a Hypolipidemic Agent in Healthy Normal Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Hyperlipidemia

In brief

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.

Key facts

Study ID: NCT00685737
Run by: Pharmena North America
People needed: 20
Starts: 2007-12-01
Expected to finish: 2008-06-01
Last updated by the study team: 2008-06-27

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

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

Full record on ClinicalTrials.gov

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