Een onderzoek naar de opname, verdeling en uitscheiding van bedaquiline, een geneesmiddel tegen tuberculose, in mensen met type II diabetes
Not yet recruiting
- Conditions
- type 2 diabetes mellitustuberculosisbedaquilinecomorbiditydrug resistance
- Registration Number
- NL-OMON26912
- Lead Sponsor
- niversity Medical Center Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 36
Inclusion Criteria
Healthy volunteers must meet all of the following criteria In order to be eligible to participate in this study:
-Between 18 and 50 years of age
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Drug hypersensitivity to bedaquiline.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A population approach PK model will be developed, describing the plasma bedaquiline concentrations over time. The pharmacokinetic endpoints reported depend on the model structure that describes the data best, but will include model parameters (e.g. volumes of distribution, clearances) and model derived parameters for exposure when appropriate (e.g. the area under the plasma concentration-time curve from zero to infinity, the maximum plasma concentration, time to reach maximum plasma concentration, half-life)
- Secondary Outcome Measures
Name Time Method When appropriate, covariates will be identified (e.g. CYP3A4 phenotype or bodyweight) that explain inter-individual variability. Particular focus will lie on identifying the covariates CYP3A4 phenotype, disease status (T2DM vs. healthy controls), HbA1C, UACR and type of medication (e.g. metformin vs. SUD).