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

Heidelberg University

Status and phase

Completed

Phase 1

Conditions

Healthy Subjects

Treatments

Drug: Nicotinic Acids

Study type

Interventional

Funder types

Other

Identifiers

NCT01258491

K115

Details and patient eligibility

About

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

Enrollment

18 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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