Nicotinic Acid - Pharmacokinetics, Pharmacodynamics, Receptor Expression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Heidelberg University.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00176020
First received: September 12, 2005
Last updated: March 14, 2006
Last verified: August 2005

September 12, 2005
March 14, 2006
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Complete list of historical versions of study NCT00176020 on ClinicalTrials.gov Archive Site
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Nicotinic Acid - Pharmacokinetics, Pharmacodynamics, Receptor Expression
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

The study will be a double-blind, randomized, placebo-controlled, single-center, 2 treatment, 3-­way crossover. Subjects will be randomly allocated to a treatment sequence – AAB, ABA or BAA. The two treatments will be:

  • Treatment A: 500 mg nicotinic acid (Niacor(R))
  • Treatment B: Niacor(R) Placebo

Each trial period will last one day, there will be a wash-out period of at least 2 days between each trial period. Five to seven days after study day 1 of trial period 3 there will be a final safety examination.

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Interventional
Phase 1
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Healthy
Drug: nicotinic acid
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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Inclusion Criteria:

  • Good state of health physically and mentally

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
  • Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
  • Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study
  • Subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study
Both
18 Years to 45 Years
Yes
Contact: Brigitte Tubach, R:N: brigitte.tubach@med.uni-heidelberg.de
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NCT00176020
2005-003234-18, K115
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Heidelberg University
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Principal Investigator: Gerd Mikus, MD Bsc Department Internal Medicine VI
Heidelberg University
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP