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

Healthy Subjects 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: Completed

Administrative data

• NCT number: NCT01258491
• Other study ID #: K115
• Status: Completed
• Phase: Phase 1
• First received: December 10, 2010
• Last updated: December 10, 2010
• Start date: May 2005
• Est. completion date: December 2005

Study information

• Verified date: December 2005
• Source: Heidelberg University
• Contact: n/a
• 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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• Nicotinic Acids

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University