Nicotinic Acid - Pharmacokinetics, Pharmacodynamics, Receptor Expression

NCT00176020 | Unknown Phase 1

• 2 other identifiers: 2005-003234-18K115
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

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

Keywords

nicotinic acid; flush symptom; pharmacodynamic; pharmacokinetic

Interventions

nicotinic acid DRUG

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Good state of health physically and mentally

You may not qualify if:

• 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

Sponsors & Collaborators

• Heidelberg University: lead

MeSH Terms

Interventions

Niacin

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Gerd Mikus, MD Bsc

  Department Internal Medicine VI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brigitte Tubach, R:N:

CONTACT

brigitte.tubach@med.uni-heidelberg.de

Study Design

• Study Type: interventional
• Phase: phase 1
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Last Updated: March 15, 2006

Record last verified: 2005-08