A Study of Different Forms of BGB-43395 and Food Effect in Healthy Participants

BeiGene

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: BGB-43395

Study type: Interventional

Funder types: Industry

Identifiers

NCT06761898

BGB-43395-103

Details and patient eligibility

About

Study to determine the relative bioavailability of BGB-43395 solid dispersion tablet compared to salt tablet in healthy adult participants in Part 1 and the effect of food on the selected BGB-43395 formulation solid dispersion tablet or salt tablet in healthy adult participants in Part 2.

Enrollment: 51 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female, of any race, between 18 and 65 years of age
• Body mass index between 18.0 and 32.0 kg/m2, inclusive
• In good health, as determined by no clinically significant findings from medical history
• Able to comprehend and are willing to sign the ICF and abide by the study restrictions

Exclusion criteria

• Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator or designee
• History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, as determined by the investigator or designee.
• History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair are allowed)
• Confirmed systolic blood pressure >140 or <90 mmHg, diastolic blood pressure >90 or <50 mmHg, or pulse rate >100 or <40 beats per minute. If any parameter is out of range, measurements should be repeated twice. Participants will be excluded if the average of the 3 measurements are outside of the corresponding reference range.
• History of prolonged QT interval/QT interval corrected for heart rate, with QTcF >450 ms for males and >470 ms for females.
• History or current diagnosis of diabetes, with a HbA1c ≥6.5% or fasting blood glucose level ≥126 mg/dL at screening alanine aminotransferase (ALT), aspartate aminotransferase (AST), or total bilirubin >1.5 × upper limit of normal (ULN) (except for participants with Gilbert's syndrome, where total bilirubin should not be >2 × ULN) at screening and check-in.
• eGFR <90 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) 2021)
• Hemoglobin <lower limit of normal (LLN), white blood cell count <LLN, absolute neutrophil count <LLN, or platelet count <LLN at screening and check-in.
• Positive hepatitis panel and/or positive human immunodeficiency virus test.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Part 1: Relative Bioavailability

Experimental group

Description:

Participants will receive a single dose of each formulation of BGB-43395 in separate periods across various sequences.

Treatment:

Drug: BGB-43395

Drug: BGB-43395

Part 2: Food Effect

Experimental group

Description:

Participants will receive three doses of the selected formulation of BGB-43395 under fasted, low-fat, or high-fat conditions in separate periods across various sequences.

Treatment:

Drug: BGB-43395

Drug: BGB-43395