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Nicotinic Acid - Pharmacokinetics, Pharmacodynamics, Receptor Expression

H

Heidelberg University

Status and phase

Unknown
Phase 1

Conditions

Healthy

Treatments

Drug: nicotinic acid

Study type

Interventional

Funder types

Other

Identifiers

NCT00176020
K115
2005-003234-18

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial contacts and locations

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Central trial contact

Brigitte Tubach, R:N:

Data sourced from clinicaltrials.gov

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