A Study to Investigate the Relative Bioavailability of 2 Tablet Formulations and the Effect of Food on the Pharmacokinetics of BGB-58067 in Healthy Participants
A Phase 1, Single Dose, Open-label, Randomized 4-Period, 4-Sequence Crossover Study to Assess the Relative Bioavailability of Two Tablet Formulations of BGB-58067 and the Effect of Food on the Pharmacokinetics of a Single Oral Dose of BGB-58067 Administered Simultaneously to Healthy Adult Participants
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
BGB-58067 works by blocking a protein in the body called PRMT5. Although all cells need PRMT5 to function normally, cancer cells depend on it more heavily for growth and survival. BGB-58067 has been designed to work in cancer cells that are missing a gene called MTAP (about 15% of all cancers). The aim of this approach is to target cancer cells and reduce harm to healthy tissues and reduce side-effects.
BeOne Medicines is developing a new tablet formulation of BGB-58067 (called F-02) which has minor changes in its composition compared to the existing formulation (called F-01). The study will be conducted in healthy adults.
The purpose of this study is to test whether the amount of BGB-58067 in the blood and the speed at which it enters the bloodstream after taking the new formulation are similar to those observed with the existing formulation.
Participants will each take 1dose of BGB-58067 orally (by mouth) with or without food during the treatment part of the study. Both participants and the study doctors will know what study drug participants are given.
About 32 participants in Australia will take part in this study. The overall time to participate in this study is around 12 weeks. Participants will stay at the clinic during the treatment part of the study and will have physical exams and blood tests.
Studietype
Inschrijving (Geschat)
Fase
- Fase 1
Contacten en locaties
Studiecontact
- Naam: Study Director
- Telefoonnummer: 1-877-828-5568
- E-mail: clinicaltrials@beonemed.com
Studie Locaties
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South Australia
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Adelaide, South Australia, Australië, SA 5000
- Werving
- CMAX Clinical Research
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Participants must be 18 to 65 years of age, inclusive, at the time of signing the ICF.
- Participants who are overtly healthy, as determined by the investigator or delegate through medical evaluation
- Female participants must be of non-childbearing potential. Note: A woman is considered 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 90 days after the last dose of BGB-58067.An additional highly effective method of birth control must be used for the duration of the study and for 90 days 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:
- 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 allowed unless it is active (ie, No clinically meaningful allergy symptoms at screening and pre-dose, no requirement for pharmacologic therapy, and stable condition without anticipated flare during the PK assessment period).
- History of clinically significant cardiovascular, hematological, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric (including SIB) disorder, or severe cutaneous adverse reactions such as Stevens-Johnson Syndrome, as judged by the investigator or delegate.
- Participants with a history of cholecystectomy or gall stones.
Note: Other protocol-defined inclusion/exclusion criteria may apply.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Treatment Sequence 1
Participants will receive a single oral dose of BGB-58067 F-01 tablet in fasted state, BGB-58067 F-02 tablet in fasted state, BGB-58067 F-02 tablet in the fed state with a high fat meal, and BGB-58067 F-02 tablet in the fed state with a low fat meal, with a 7-day washout between each dose.
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Administered orally
Administered orally
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Experimenteel: Treatment Sequence 2
Participants will receive a single oral dose of BGB-58067 F-02 tablet in fasted state, BGB-58067 F-02 tablet in the fed state with a low fat meal, BGB-58067 F-01 tablet in fasted state, and BGB-58067 F-02 tablet in the fed state with a high fat meal, with a 7-day washout between each dose.
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Administered orally
Administered orally
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Experimenteel: Treatment Sequence 3
Participants will receive a single oral dose of BGB-58067 F-02 tablet in fed state with low-fat meal, F-02 tablet in the fed state with a high fat meal, BGB-58067 F-02 tablet in fasted state, and BGB-58067 F-01 tablet in fasted state, with a 7-day washout between each dose.
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Administered orally
Administered orally
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Experimenteel: Treatment Sequence 4
Participants will receive a single oral dose of BGB-58067 F-02 tablet in fed state with high-fat meal, BGB-58067 F-01 tablet in fasted state, BGB-58067 F-02 tablet in the fed state with a low fat meal, and BGB-58067 F-02 tablet in fasted state, with a 7-day washout between each dose.
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Administered orally
Administered orally
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Area under the Plasma Concentration-Time Curve from Time 0 Infinity (AUC0-inf) for BGB-58067
Tijdsspanne: Approximately 4 Days
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Approximately 4 Days
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Area under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-t last) for BGB-58067
Tijdsspanne: Approximately 4 Days
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Approximately 4 Days
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Maximum Observed Plasma Concentration (Cmax) of BGB-58067
Tijdsspanne: Approximately 4 Days
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Approximately 4 Days
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Time of the Maximum Observed Concentration (Tmax) for BGB-58067
Tijdsspanne: Approximately 4 Days
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Approximately 4 Days
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Apparent Terminal Elimination Half-life (t1/2) for BGB-58067
Tijdsspanne: Approximately 4 Days
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Approximately 4 Days
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Apparent Total Clearance from Plasma after Oral Administration (CL/F) for BGB-58067
Tijdsspanne: Approximately 4 Days
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Approximately 4 Days
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Apparent Volume of Distribution at Steady State after Extravascular Administration (Vz/F) for BGB-58067
Tijdsspanne: Approximately 4 Days
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Approximately 4 Days
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Participants with Adverse Events (AEs)
Tijdsspanne: Approximately 53 Days
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Number of participants with adverse events (AEs), abnormal vital signs, electrocardiogram (ECG) findings, clinically significant physical examination abnormalities, and clinically significant laboratory abnormalities.
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Approximately 53 Days
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: Study Director, BeOne Medicines
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- BGB-58067-103
Plan Individuele Deelnemersgegevens (IPD)
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Beschrijving IPD-plan
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.
IPD-tijdsbestek voor delen
IPD-toegangscriteria voor delen
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- MVO
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