Safety of a Hypolipidemic Agent in Healthy Normal Volunteers

NCT00685737 | Completed Phase 1

• 1 other identifier: PNAI-002
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperlipidemia

Keywords

Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• The single dose pharmacokinetics and safety of 1-MNA and an assessment of any gender-based differences in plasma pharmacokinetics

  Over 24 hours following a dose

Secondary Outcomes (1)

• The effect of 1-MNA on triglycerides and lipase activity and lipid profiles after single oral dosages

  Over 24 hours following a single dose

Study Arms (3)

1

ACTIVE COMPARATOR

1-MNA-Low Dose

Drug: 1-MNA

2

ACTIVE COMPARATOR

1-MNA-High Dose

Drug: 1-MNA

3

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

1-MNA DRUG

Capsule

1; 2

Placebo DRUG

Capsule

Also known as: Placebo Comparator

3

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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
• 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.

Sponsors & Collaborators

• Pharmena North America: lead

Study Sites (1)

Buffalo Clinical Research Center

Buffalo, New York, 14202, United States

Location

MeSH Terms

Conditions

Hyperlipidemias

Condition Hierarchy (Ancestors)

Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Charles H Ballow, Pharm D.

  Buffalo Clinical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 23, 2008
• First Posted: May 28, 2008
• Study Start: December 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: June 27, 2008

Record last verified: 2008-06

Locations

US (1)