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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

This study has been completed.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT01258491
First received: December 10, 2010
Last updated: NA
Last verified: December 2005
History: No changes posted
  Purpose

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 Intervention Phase
Healthy Subjects
Drug: Nicotinic Acids
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Enrollment: 18
Study Start Date: May 2005
Study Completion Date: December 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Prof. Dr. Gerd Mikus, University Hospital
ClinicalTrials.gov Identifier: NCT01258491     History of Changes
Other Study ID Numbers: K115
Study First Received: December 10, 2010
Last Updated: December 10, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Niacin
Niacinamide
Nicotinic Acids
Antimetabolites
Cardiovascular Agents
Growth Substances
Hypolipidemic Agents
Lipid Regulating Agents
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Vasodilator Agents
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on November 25, 2014