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Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of a Single Oral Repeated Dose of 500 mg Nicotinic Acid as Tablets in Healthy Subjects

Sponsor
Heidelberg University (Other)
Overall Status
Completed
CT.gov ID
NCT01258491
Collaborator
(none)
18
Enrollment
7
Duration (Months)

Study Details

Study Description

Brief Summary

The study will be a double-blind, randomized, placebo-controlled, single-center, 2 treatment,3-way crossover to investigate the pharmacodynamics, i.e. the flush-symptom of a single oral repeated dose of 500 mg nicotinic acid in healthy subjects. Subjects will be randomly allocated to a treatment sequence - AAB, ABA or BAA. The two treatments will be:

  • Treatment A: 500 mg nicotinic acid

  • Treatment B: Placebo

Condition or Disease Intervention/Treatment Phase
  • Drug: Nicotinic Acids
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double
Primary Purpose:
Basic Science
Official Title:
Double-blind, Randomized, Placebo-controlled, Single-center, 2 Treatment, 3-way Crossover Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of a Single Oral Repeated Dose of 500 mg Nicotinic Acid as Tablets in Healthy Subjects
Study Start Date :
May 1, 2005
Actual Primary Completion Date :
Nov 1, 2005
Actual Study Completion Date :
Dec 1, 2005

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Body weight between 50 and 90 kg with a body mass index between 19 and <30 kg/m2

    • No clinically relevant findings in the medical history, laboratory examinations and physical examination, especially with regard to cardiovascular system, liver function test, bilirubin values and the skin

    • No clinical relevant pathological findings in electrocardiogram (ECG)

    • Normal blood pressure (BP, syst. 100 to 140 mmHg, diast. 60 to 90 mmHg) and pulse rate (between 50 and 90 beats/min) in sitting position

    • Voluntarily signed informed consent after full explanation of the study to the participant

    Exclusion Criteria:

    • Treatment with any other investigational product in the last 60 days before the day of randomization into the study

    • Regular use of medication in the last 60 days before the day of randomization into the study except of oral contraceptives in female participants

    • Treatment in the 60 days before the day of randomization into the study with any drug known to have a well-defined potential for toxicity to a major organ, or any substance which is known to induce or inhibit hepatic drug metabolism (including general anesthetics)

    • Any drug intake (including over-the-counter remedies) in the 2 weeks before the day of randomization into the study, unless the investigator considers a drug intake to be clinically irrelevant for the purpose of this study

    • Any acute or chronic illness or clinically relevant findings in the pre-study examination

    • Presence, history or sequelae of gastrointestinal (e.g. peptic ulcer), liver or kidney disease, or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs

    • History of hypersensitivity to the investigational product

    • History or presence of abnormalities of the vascular bed

    • History or presence of a dermatologic disease or skin lesions, particular in the area chosen for flush measurement

    • History of allergy or hypersensitivity to other drugs or to food constituents

    • History of other allergic diseases or hypersensitivity, unless the investigator considers it to be clinically irrelevant for the purpose of this study

    • Blood donation of >400 ml in the 60 days before the day of randomization into the study

    • Smoking

    • Positive result in urine screen for drugs of abuse or in alcohol breath test

    • Known or suspected to be drug-dependent, including consumption of >30 g alcohol per day

    • Pregnancy or lactation

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Heidelberg University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01258491
    Other Study ID Numbers:
    • K115
    First Posted:
    Dec 13, 2010
    Last Update Posted:
    Dec 13, 2010
    Last Verified:
    Dec 1, 2005
    Additional relevant MeSH terms:
    Nicotinic Acids
    Niacin
    Niacinamide

    Study Results

    No Results Posted as of Dec 13, 2010