Pharmacokinetics of nutritional conditioning

Pharmacokinetics of nutritional conditioning - PK of nutritional conditioning

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39061

Enrollment

Registered

2012-11-05

Start date

2012-12-18

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

This study consists of six treatment arms (N=9 per arm). Subjects will be randomized for the sequence in which they receive a single oral (A1,A2,A3) or intravenous (A4,A5,A6) administration of a dru

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)