Nicotinic Acid - Pharmacokinetics, Pharmacodynamics, Receptor Expression - Full Text View

Sponsored by:	University of Heidelberg
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00176020

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: nicotinic acid	Phase I

Drug Information available for: Niacin Niacinamide Niacin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
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

Further study details as provided by University of Heidelberg:

Estimated Enrollment:

18

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176020

Contacts

Contact: Brigitte Tubach, R:N:

brigitte.tubach@med.uni-heidelberg.de

Sponsors and Collaborators

University of Heidelberg

Investigators

Principal Investigator:

Gerd Mikus, MD Bsc

Department Internal Medicine VI

More Information

No publications provided

Study ID Numbers:	2005-003234-18, K115
Study First Received:	September 12, 2005
Last Updated:	March 14, 2006
ClinicalTrials.gov Identifier:	NCT00176020 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:

nicotinic acid
flush symptom
pharmacodynamic
pharmacokinetic

Study placed in the following topic categories:

Antimetabolites
Vasodilator Agents
Niacinamide
Vitamin B Complex
Antilipemic Agents
Trace Elements
Healthy

Cardiovascular Agents
Nicotinic Acids
Vitamins
Flushing
Micronutrients
Niacin

Additional relevant MeSH terms:

Antimetabolites
Vasodilator Agents
Niacinamide
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Growth Substances
Antilipemic Agents
Physiological Effects of Drugs

Cardiovascular Agents
Pharmacologic Actions
Nicotinic Acids
Vitamins
Therapeutic Uses
Micronutrients
Niacin

ClinicalTrials.gov processed this record on May 07, 2009