Study on pharmacy prepared CDCA capsules

Pharmacokinetic cross-over study of compounded chenodeoxycholic acid

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23443

Enrollment

Registered

2021-09-03

Start date

2022-09-27

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Cerebrotendinous Xanthomatosis

Interventions

CDCA 250 mg capsule

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
Pharmacokinetic profile of compounded CDCA capsules	—

Secondary

Measure	Time frame
Effect on bile acid profile	—

Contacts

Public ContactNatalja Bouwhuis

Amsterdam UMC

n.bouwhuis@amsterdamumc.nl0611450891

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)