Nicotinic Acid - Pharmacokinetics, Pharmacodynamics, Receptor Expression

NCT ID: NCT00176020

Last Updated: 2006-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL

Brief Summary

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.

Conditions

Healthy

Interventions

nicotinic acid

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Principal Investigators

Gerd Mikus, MD Bsc

Role: PRINCIPAL_INVESTIGATOR

Department Internal Medicine VI

Central Contacts

Brigitte Tubach, R:N:

Role: CONTACT

brigitte.tubach@med.uni-heidelberg.de

Other Identifiers

K115

Identifier Type: -

Identifier Source: secondary_id

2005-003234-18

Identifier Type: -

Identifier Source: org_study_id