Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of a Single Oral Repeated Dose of 500 mg Nicotinic Acid as Tablets in Healthy Subjects

NCT ID: NCT01258491

Last Updated: 2010-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2005-12-31

Brief Summary

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

Conditions

Healthy Subjects

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Interventions

Nicotinic Acids

Intervention Type: DRUG

Eligibility 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

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

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

University Hospital

Other Identifiers

K115

Identifier Type: -

Identifier Source: org_study_id