A Study to Evaluate the Effects of Phenytoin and Itraconazole on Sonrotoclax (BGB-11417) in Healt… (NCT06543043) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate the Effects of Phenytoin and Itraconazole on Sonrotoclax (BGB-11417) in Healthy Volunteers
United States30 participantsStarted 2024-08-19
Plain-language summary
This is a single-center, open-label, parallel group study designed to investigate the effect of CYP3A induction and inhibition following multiple doses of phenytoin (Part A) and itraconazole (Part B), respectively, on the pharmacokinetics of sonrotoclax in healthy volunteers.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion Criteria:
* Able to understand and sign a written informed consent
* Able and willing to comply with all study requirements
* Healthy males or healthy females of non-childbearing potential
* Agrees to use an adequate method of contraception
* Body mass index (BMI) of 18.0 to 32.0 kg/m\^2 as measured at screening or, if outside the range, considered not clinically significant by the investigator.
Exclusion Criteria:
* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency (HIV) antibody results
* Prior treatment with sonrotoclax
* Evidence of renal impairment at screening
* Any contraindication to the use of phenytoin (Part A) or itraconazole (Part B)
* Current smokers and those who have smoked within the last 12 months
* Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
* History of any drug or alcohol abuse in the past 2 years
* Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
* History of clinically significant disorders as judged by the investigator
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
What they're measuring
1
Parts A and B: Lag time before observation of quantifiable concentrations in plasma (Tlag) of sonrotoclax
Timeframe: Approximately 21 days for Part A and 11 days for Part B
2
Parts A and B: Time to maximum observed concentration (Tmax) of sonrotoclax
Timeframe: Approximately 21 days for Part A and 11 days for Part B
3
Parts A and B: Maximum observed plasma concentration (Cmax) of sonrotoclax
Timeframe: Approximately 21 days for Part A and 11 days for Part B
4
Parts A and B: Area under the concentration time curve from time zero up to the last quantifiable concentration (AUClast) of sonrotoclax
Timeframe: Approximately 21 days for Part A and 11 days for Part B
5
Parts A and B: Area under the concentration time curve from time zero extrapolated to infinity (AUCinf) of sonrotoclax
Timeframe: Approximately 21 days for Part A and 11 days for Part B
6
Parts A and B: Terminal phase elimination rate constant (lambda-z) of sonrotoclax
Timeframe: Approximately 21 days for Part A and 11 days for Part B
7
Parts A and B: Terminal elimination half life (T1/2) of sonrotoclax