Single Dose Administration of Ketamine 10, 20, 40 and 80 mg and 5 mg Solution for Infusion in 15 Healthy Subjects

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed for descriptive pharmacokinetic characterization of ketamine and norketamine in serum, urine and feces after oral single dose administration of a new developed prolonged release tablet formulation containing 10, 20, 40 and 80 mg ketamine under fasting conditions and for descriptive pharmacokinetic characterization of ketamine and norketamine in serum, urine and feces after intravenous single dose administration of 5 mg ketamine solution for infusion within 30 min

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Medicine Greifswald
• Treatments: Ketamine

Criteria

Inclusion Criteria:

• age: 18 - 45 years

• sex: male or female

• ethnic origin: Caucasian

• body mass index: > 18.5 kg/m² and < 30 kg/m²

• good health as evidenced by the results of the clinical examination, ECG, and the laboratory check-up, which will be judged by the clinical investigator not to differ in a clinically relevant way from the normal state

• heart frequency between 50 and 90 bpm

• blood pressure between 140 and 100 systolic and 90 and 60 diastolic

• written informed consent

Exclusion Criteria:

• hepatic and renal diseases and/or pathological findings, which might interfere with pharmacokinetics of the study medication

• existing cardiovascular or haematological diseases and/or pathological findings, which might interfere with the drug's safety, tolerability and/or pharmacokinetics (e.g. tachycardia > 90 bpm, bradycardia < 50 bpm, ischemic heart disease like angina pectoris instabilis or myocardial infarction in the last 6 months, hypertension > 140/90 mm Hg)

• gastrointestinal diseases and/or pathological findings (e.g. stenoses), which might interfere with pharmacokinetics of the study medication

• hypersensitivity to the active ingredient ketamine or any of the excipients

• (pre-) eclampsia

• poor or untreated hyperthyreosis

• increased intracranial pressure

• glaucoma or perforating eye injury

• drug or alcohol dependence

• positive drug or alcohol screening

• smokers of 10 or more cigarettes (or equivalent) per day

• positive results in HIV, HBV or HCV screenings

• volunteers, who are on a diet, which could affect the pharmacokinetics of the drug

• heavy tea or coffee drinkers (more than 1L per day)

• lactation, pregnancy test positive or not performed or women of child-bearing age without safe contraception, as described on page 18, ch. 7.4.1. (Note for Guidance on Non-clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceutical (CPMP/ICH/286/95 modifications))

• volunteers, suspected or known, not to follow instructions of the clinical investigators

• volunteers, who are unable to understand the written or verbal instructions, in particular regarding the risks and inconveniences, they will be exposed to, as a result of their participation in the study

• volunteers, liable to orthostatic dysregulation, fainting, or blackouts

• participation in a clinical trial during the last 3 months prior to the start of the study

• less than 14 days after last acute disease

• less than 3 months after last blood donation

• intake of thyroid hormones or sympathomimetics

• any medication within 4 weeks prior to the intended first administration of the study medication, which might influence functions of the gastrointestinal tract (e.g. laxatives, metoclopramide, loperamide, antacids, H2-receptor antagonists, proton pump inhibitors, anticholinergics)

• any other medication within two weeks prior to the first administration of the study medication, but at least 10-time the half-live of the respective drug (except oral contraceptives)

• intake of grapefruit containing food or beverages within 14 days prior to administration of the study medication

• intake of poppy seed containing food or beverages within 14 days prior to administration of the study medication

• known allergic reactions to the active ingredients used or to constituents of the study medication