Cmax Clinical Research
Adelaide, South Australia, SA 5000, Australia
Location status: Recruiting
NCT Number: NCT07590102
This study is being done to understand how the body processes the study drug (BGB-58067) when it is taken together with other medicines.
BGB-58067 is mainly broken down in the body by a liver enzyme called CYP3A. Some medicines can affect how this enzyme works. For example, certain medicines can increase the production of the enzyme (called inducers), while others can block or inhibit its activity (called inhibitors). This may change how much of the study drug is present in the bloodstream.
In this study, we will give BGB-58067 together with two commonly used medicines:
* Part A: Phenytoin (inducer), which can increase the production of the enzyme, and * Part B: Itraconazole (inhibitor), which can inhibit the activity of the enzyme.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 1
Adelaide, South Australia, SA 5000, Australia
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
a. Body Mass Index (BMI) of 18.0 to 32.0 kg/m2 inclusive.
Exclusion criteria
Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
Administered orally
Administered orally
Administered orally
Time frame: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Time frame: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Time frame: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Time frame: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Time frame: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Time frame: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Time frame: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
Time frame: Up to approximately 30 days
Safety will be assessed by monitoring and recording of all treatment emergent adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v6.0
Contact information is provided by the study sponsor or research team.
BeOne Medicines
Industry
An Open-Label, Parallel Group Study Designed to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-58067 in Healthy Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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