- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07590102
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
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
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Fase 1
Contatti e Sedi
Contatto studio
- Nome: Study Director
- Numero di telefono: 1-877-828-5568
- Email: clinicaltrials@beonemed.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
Inclusion 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 screening and check-in as determined by the investigator, with additional requirements as follows:
a. Body Mass Index (BMI) of 18.0 to 32.0 kg/m2 inclusive.
- 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 sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy
- 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 control is highly recommended for the duration of the study and for 3 months after the last dose of BGB-58067. A sterile man is defined as one for whom azoospermia has been previously demonstrated in a semen sample examination as definitive evidence of infertility. Men with known "low sperm counts" (consistent with "subfertility") are not to be considered sterile for purposes of this study
Exclusion Criteria:
- 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 study site). Hay fever is not an exclusion criterion unless it is active
- 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 severe cutaneous adverse reactions (SCAR) such as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), as judged by the investigator.
- 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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Part A: BGB-58067 + Phenytoin (CYP3A Inducer)
Participants will receive BGB-58067 on Day 1 and Day 18 and phenytoin on Days 4 to 20.
|
Somministrato per via orale
Administered orally
|
|
Sperimentale: Part B: BGB-58067 + Itraconazole (CYP3A Inhibitor)
Participants will receive BGB-58067 on Days 1 and 8 and itraconazole on Days 4 to 11.
|
Somministrato per via orale
Administered orally
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Part A and Part B: Time of the Maximum Observed Concentration (Tmax) of BGB-58067
Lasso di tempo: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
|
Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
|
|
Part A and Part B: Maximum Observed Concentration (Cmax) of BGB-58067
Lasso di tempo: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
|
Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
|
|
Part A and Part B: Area Under the Concentration-time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of BGB-58067
Lasso di tempo: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
|
Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
|
|
Part A and Part B: Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-∞) of BGB-58067
Lasso di tempo: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
|
Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
|
|
Part A and Part B: Apparent Terminal Elimination Half-life (t1/2) of BGB-58067
Lasso di tempo: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
|
Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
|
|
Part A and Part B: Apparent Total Clearance (CL/F) of BGB-58067
Lasso di tempo: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
|
Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
|
|
Part A and Part B: Apparent Volume of Distribution During the Terminal Phase (Vz/F) of BGB-58067
Lasso di tempo: Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
|
Part A: Day 1 and Day 18; Part B: Day 1 and Day 8
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Part A and Part B: Number of Participants with Adverse Events (AEs)
Lasso di tempo: 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
|
Up to approximately 30 days
|
Collaboratori e investigatori
Sponsor
Investigatori
- Direttore dello studio: Study Director, BeOne Medicines
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- BGB-58067-102
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.
BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.
Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Periodo di condivisione IPD
Criteri di accesso alla condivisione IPD
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- RSI
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .