Cancer
Conditions
Interventions
Tamoxifen
Sponsors
AiBST
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female subjects aged 18 to 30 years (inclusive). Good health as determined by past medical history, physical examination, vital signs, ECG, and laboratory tests at screening. Be able to communicate and understand the consent process Be of the following CYP2D6 genotypes: CYP2D6*1/*1, CYP2D6*1/*2, CYP2D6*2/*2, CYP2D6*1/*17 and CYP2D6*17/*17 BMI between 19 to 27 kg/m2 (inclusive)
Exclusion criteria
Exclusion criteria: 1. Pregnant women 2. On medication that is known to inhibit CYP2D6 such as antidepressants and antipsychotics 3. Any other CYP2D6 genotypes which are not CYP2D6*1/*1, CYP2D6*1/*2, CYP2D6*2/*2, CYP2D6*1/*17 and CYP2D6*17/*17 4. Breastfeeding women 5. Smokers who report a daily use more than 10 cigarettes 6. Use of prescription drugs or OTC medication 7. Participation in any clinical in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics of Tamoxifen and formation of endoxifen in subgroups of different CYP2D6 genotypes of interest to the study. Assessment and comparison between the PK parameters of Tamoxifen for 3 subgroups of the respective value of AUC0-t, AUCinf, Cmax, Tmax and T1/2. | — |
Secondary
| Measure | Time frame |
|---|---|
| PK modeling and simulation based pharmacogenetics guided dosing algorithm in the use of Tamoxifen carriers of the CYP2D17 variants. | — |
Countries
Zimbabwe
Contacts
Public ContactGeorginah Nyabadza
Clinical Trial Manager
Outcome results
None listed