Clinical trial NCT01258491: Study to Investigate the Pharmacodynamics, Pharmacokinetics and Safety of a Single Oral Repeated Dose of 500 mg Nicotinic Acid as Tablets in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2010-12-13
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: