Pharmacokinetics and pharmacogenomics of Tamoxifen in healthy volunteers: The effects of African specific CYP2D6*17 genotype on the plasma levels of Tamoxifen and its metabolites

Phase 1

Recruiting

• Conditions: Cancer

• Registration Number: PACTR202106791732070
• Lead Sponsor: AiBST

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-07
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 42

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
PK modeling and simulation based pharmacogenetics guided dosing algorithm in the use of Tamoxifen carriers of the CYP2D17 variants.