To investigate the pharmacokinetic profile of magistrally compounded CDCA capsules.
ID
Source
Brief title
Condition
- Endocrine disorders congenital
Health condition
Cerebrotendinous Xanthomatosis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacokinetic profile of compounded CDCA capsules
Secondary outcome
Effect on bile acid profile
Background summary
This study is an open label randomised single center cross-over study, to investigate the pharmacokinetics of compounded chenodeoxycholic acid capsules. The capsules will be compounded by the hospital pharmacy, and will via a cross-over design be compared to the commercial alternative. Healthy volunteers will take one 250 mg capsules of each, after which blood sampling will take place at various time points.
Study objective
To investigate the pharmacokinetic profile of magistrally compounded CDCA capsules.
Study design
2 visits with capsules intake followed by blood sampling, separated by a wash-out period of at least 1 week.
Intervention
Chenodeoxycholic acid
Age
Inclusion criteria
- Be 18 years of age or older - Be a male - Have a BMI between 18,5 and 30 kg/m2 - Able and willing to swallow the capsules - Able to undergo blood sampling for PK analysis - Able and willing to give written informed consent - Willing to follow the dietary restrictions - Able to complete the study
Exclusion criteria
- Inability to give informed consent - Hypersensitivity to one of the components in either product - Smoking or use of other tobacco products - History of alcohol or drug abuse - Use of co-medication (as described in chapter 5.2) - Gastrointestinal disease that may impact the absorption - Metabolic or endocrine disease - Gallbladder disease and/or removal - Liver disease - Participation in another clinical trial during or in the 3 months prior to the study
Design
Recruitment
IPD sharing statement
Plan description
Kamer G4-214
Postbus 22660
1100 DD Amsterdam
020 566 7389
mecamc@amsterdamumc.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL9736 |
| Other | METC AMC : 2021_205 |
| EudraCT | 2021-003823-14 |
| CCMO | NL78477.018.21 |
| OMON | NL-OMON49918 |