Pharmacokinetics of nutritional conditioning

Completed

Conditions: farmacokinetiek van geneesmiddelen en galzouten, niet specifiek tbv een/meerdere aandoeningen
not applicable (zie C21)

Registration Number: NL-OMON39061

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 9

Inclusion Criteria

- Healthy (determined by an experienced physician) male of 18 years or older at the time of signing the informed consent.
- Normal renal and liver function
- Capable of giving written informed consent and to comply with the requirements and restrictions listed in the informed consent form

Exclusion Criteria

- Major illness in the past 3 months
- Gastrointestinal disease which may influence drug absorption,
- Abnormalities in ASAT / ALAT / Bilirubin / gammaGT / AF laboratory data
- Drug abuse or alcoholism (>3 units of alcohol per day)
- Participation in another clinical trial in the past 12 months,
- Difficulty in donating blood or limited accessibility of a vein
- Use of tobacco products (induction liver enzymes)
- (chronisch) gebruik van medicatie

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary study endpoint is the difference in area under the plasma concentration<br /><br>versus time curve (AUC) for each drug following the administration of the drug<br /><br>cocktail after 36 hours of starvation (A2,A5) and after 3 days of a high fat<br /><br>meal (A3,A6) in comparison with the control situation of an overnight fast<br /><br>(A1,A4). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include the difference in the PK parameters clearance,<br /><br>volume of distribution, absorption rate, mean residence time and elimination<br /><br>half-life.<br /><br>Furthermore, to study the effect of nutritional conditioning on first pass<br /><br>metabolism, the difference in area under the plasma concentration versus time<br /><br>curve (AUC) of the intravenous (A4,A5,A6) and oral (A1,A2,A3) drug cocktail<br /><br>will be studied.<br /><br>Also, the effect of short term starvation and short term high fat diet on<br /><br>metabolic parameters, such as postprandial glucose, insulin, GLP-1, FGF 19 and<br /><br>bile acid levels will be assessed. </p><br>