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CompletedNCT00685737PNAI-002Updated Jun 27, 2008

Safety of a Hypolipidemic Agent in Healthy Normal Volunteers

A Phase 1 interventional study of 1-MNA and Placebo in Hyperlipidemia, sponsored by Pharmena North America. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-06-27.

Sponsored by Pharmena North America · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hyperlipidemia

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Keywords

  • Hyperlipidemia
03

In context

Hyperlipidemias

840 studies on the registry are indexed under Hyperlipidemias; 107 are open to participants now.

This study's enrollment of 20 is below the median of 88 across 707 interventional studies indexed under Hyperlipidemias.

Browse Hyperlipidemias studies →

Lead sponsor

This is the only study on the registry with Pharmena North America as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    1

    1-MNA-Low Dose

    Drug: 1-MNA

  • Active comparator
    2

    1-MNA-High Dose

    Drug: 1-MNA

  • Placebo comparator
    3

    Placebo

    Drug: Placebo

Interventions

  • Drug1-MNA

    Capsule

  • DrugPlacebo

    Capsule

    Also known as: Placebo Comparator

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

07

Study locations

1 site
  • Buffalo Clinical Research Center
    Buffalo, New York 14202, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Dec 2007, a primary completion of Jun 2008 and a completion of Jun 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2008
First posted
May 28, 2008
Start
Dec 2007
Primary completionActual
Jun 2008
CompletionActual
Jun 2008
Last update
Jun 27, 2008
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 27, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00685737
Lead sponsor
Pharmena North America
First posted
May 28, 2008
Start date
Dec 2007
Primary completion
Jun 2008
Completion
Jun 2008
Last update
Jun 27, 2008

Study contacts

Charles H Ballow, Pharm D.
principal investigator · Buffalo Clinical Research Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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Discussion

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