Nicotinic Acid - Pharmacokinetics, Pharmacodynamics, Receptor Expression

Healthy Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00176020
• Other study ID #: 2005-003234-18
• Secondary ID: K115
• Status: Not yet recruiting
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: March 14, 2006

Study information

• Verified date: August 2005
• Source: Heidelberg University
• Contact: Brigitte Tubach, R:N:
• Email: brigitte.tubach[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• nicotinic acid

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University