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Official title A Study to Investigate the Effect of the CYP3A Inducer Phenytoin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of BGB-58067 in Healthy Participants
ClinicalTrials.gov ID: NCT07590102
What this study is testing
What is BGB-58067?
BGB-58067 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healthy volunteers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Participants must sign the Informed Consent Form (ICF) and be capable of giving written informed consent, which includes compliance with the...
- Participants must be willing and able to comply with all study requirements.
- Participants who are overtly healthy as determined by medical evaluation including medical history, clinical laboratory assessments, vital sign...
- Female participants must be of no childbearing potential. Note: A female participant is considered of childbearing potential (ie, fertile, following...
- Nonsterile male participants must be willing to use condom and refrain from sperm donation for the duration of the study and for 3 months after the...
You likely can't join if
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- Presence or history of relevant seasonal allergies requiring treatment, drug and/or food allergies (ie, allergy to any study drug or excipients, or...
- Significant serious skin disease as judged by the investigator, including rash, food allergy, eczema, psoriasis, or urticaria
- History of clinically significant cardiovascular, hematological, renal, hepatic, chronic respiratory, or gastrointestinal (GI) disease; neurological...
- Participants with a history of cholecystectomy or gall stones
- Poor venous access that limits phlebotomy
See the full eligibility criteria
- Participants must sign the Informed Consent Form (ICF) and be capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- Participants must be willing and able to comply with all study requirements.
- Participants who are overtly healthy as determined by medical evaluation including medical history, clinical laboratory assessments, vital sign measurements,12-lead electrocardiogram (ECG), and physical examination at...
- Female participants must be of no childbearing potential. Note: A female participant is considered of childbearing potential (ie, fertile, following menarche, and until becoming postmenopausal) unless permanently...
- Nonsterile male participants must be willing to use condom and refrain from sperm donation for the duration of the study and for 3 months after the last dose of BGB-58067. An additional highly effective method of birth...
- Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
- Presence or history of relevant seasonal allergies requiring treatment, drug and/or food allergies (ie, allergy to any study drug or excipients, or any significant food allergy that could preclude a standard diet in the...
- Significant serious skin disease as judged by the investigator, including rash, food allergy, eczema, psoriasis, or urticaria
- History of clinically significant cardiovascular, hematological, renal, hepatic, chronic respiratory, or gastrointestinal (GI) disease; neurological or psychiatric (including suicidal ideation or behavior) disorder; or...
- Participants with a history of cholecystectomy or gall stones
- Poor venous access that limits phlebotomy
- Positive highly sensitive serum pregnancy test at screening, and positive highly sensitive urine test at admission. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Adelaide, South Australia, Australia
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Adelaide, South Australia, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.