Free, not protein-bound concentrations of budesonide in subcutaneous adipose tissue, muscle tissue, and serum after oral inhalation via Turbohaler®

• Conditions: Phase I healthy volunteer study

• Registration Number: EUCTR2006-002214-35-AT
• Lead Sponsor: ALTANA Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-06-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

· Subject has been informed both verbally and in writing about the objectives of the clinical study, the methods, the anticipated benefits and potential risks and the discomfort to which he/she may be exposed, and has given written consent to participation in the study prior to study start and any study-related procedure
· White (Caucasian origin) healthy male/female subjects, aged between 18 and 45 years (inclusive)
· Normal body weight as evidenced by a Body Mass Index (BMI) between > or = 18 and < or = 28kg/m², and a body weight > 50 kg
· Safe contraception in females of childbearing potential during the entire study, which means the use of effective birth-control methods such as hormonal contraceptives for at least 2 months prior to start of screening, double barrier method (condoms and diaphragms) or intra-uterine devices, which were thought to be medically acceptable forms of birth control
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Safety concerns:
· History or current evidence of allergies or idiosyncrasy to drugs or food, if considered relevant at the discretion of the investigator
· History of allergic reactions to any active or inactive ingredient of the trial medication
· History or current evidence of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrinological, metabolic, neurological, psychiatric, or other disease within the last 2 years, if considered relevant at the discretion of the investigator
· Impairment of blood coagulation
· History of malignancy within the past 5 years
· Electrocardiogram (ECG) abnormalities of relevance (assessment by investigator, e.g. QTc according to Bazett: males and females > 450 ms, PQ > or = 220 ms)
· Relevant (assessment by investigator) abnormalities in clinical chemical, hematological or any other laboratory variables
· Chronic or clinically relevant acute infections (assessment by investigator)
· Proneness to orthostatic dysregulation, fainting, or blackouts
· Positive results in any of the virology tests for HIV-Ab1 or HIV-Ab2, HCV-Ab, HBsAg.
· Drug screen positive or not performed
· Abuse of alcohol (>2 drinks/day defined according to USDA Dietary Guidelines 2005) or drugs
· Pregnant or lactating females
· ß-HCG pregnancy test (female subjects) positive or not performed

Lack of suitability for the trial:
· Treatment with any known CYP3A4-isoenzyme inducing / inhibiting agents (barbiturates, phenothiazines, cimetidine, ketoconazole etc.) and eating Brussels sprout or broccoli and eating grapefruits or star fruits, drinking of star- or grapefruit juice within two weeks prior to the study
· Use of any medication (incl. herbal and over-the-counter (OTC) medication) within two weeks before trial drug administration or within less than 10 times the elimination half-life of the respective drug, or anticipated concomitant medication during the treatment period (single intake of a drug may be accepted if judged by the investigators to have no clinical relevance and no relevance for the study objectives)
· Vegetarian diet or other peculiar dietary habits which would preclude the subject’s acceptance of standardized meals
· Surgery of the gastrointestinal tract which may interfere with drug absorption
· Participation in drug trials within the last 30 days before start of the study (last day of intake of medication – first day of medication in the following study)
· Smoking of more than 5 cigarettes daily
· Anticipated donation of spermatocytes or oocytes for medically assisted reproduction techniques (ART) within 2 months after the last dose of the present trial
· Blood donation within the last 30 days before start of the study

Administrative reasons:
· Lack of ability or willingness to give informed consent
· Anticipated non-availability for study visits/procedures.
· Anticipated lack of willingness or inability to cooperate adequately
· Vulnerable subjects (e.g. persons kept in detention)
· Anticipated lack of ability or willingness to apply safe contraception (female subjects)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: ·To assess the free unbound concentration of budesonide in Serum, Muscle tissue, and Subcutaneous adipose tissue;Secondary Objective: · To assess total concentrations (bound and unbound) of budesonide in serum<br>· To assess metabolites of budesonide in serum (if feasible)<br>· To assess safety and tolerability;Primary end point(s): Free unbound concentrations of budesonide as obtained by microdialysis in serum, muscle tissue and subcutaneous adipose tissue