Study to Assess the Bioequivalence of Ibrutinib 140 Milligram (mg) Tablet to 140 mg IMBRUVICA Capsule

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: IMBRUVICA; Drug: Ibrutinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02877225

CR108174

54179060CLL1022 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.

Enrollment: 103 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Be a man or woman between 18 and 55 years of age, inclusive, at screening
• If a woman, must have a negative serum beta human chorionic gonadotropin (Beta - hCG) pregnancy test at screening and on Day -1 of each treatment period
• Body Mass Index (BMI); weight [kilogram (kg)]/height^2 [meter(m)^2)] between 18.0 and 30.0 kg/m2 (inclusive) and body weight not less than 50 kg at screening
• If a woman, must be of nonchildbearing potential, defined as either: a) Postmenopausal : A postmenopausal state is defined as no menses for at least 12 months without an alternative medical cause and a serum follicle stimulating hormone (FSH) level in the postmenopausal range (greater (>)40 International Units Per Liter (IU/L) or milli-international units per milliliter(mIU/mL), OR, b) Permanently sterile: Permanent sterilization methods include subtotal or total hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures (without reversal operation), bilateral oophorectomy, and transcervical sterilization
• Blood pressure (supine after at least 5 minutes rest) between 90 and 140 millimeter of mercury (mmHg) systolic, inclusive, and no higher than 90 mmHg diastolic at screening
• Alanine aminotransferase, aspartate aminotransferase (AST), alkaline phosphatase (ALP) and total bilirubin equal to or lower than the upper limit of normal (per National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE]) at screening

Exclusion criteria

• History of current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the Investigator considers should exclude the participant or that could interfere with the interpretation of the study results
• Clinically significant abnormal values for hematology or biochemistry at screening as deemed appropriate by the Investigator
• Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) at screening as deemed appropriate by the Investigator
• History of clinically significant allergies, especially known hypersensitivity or intolerance to sulfonamide or beta-lactam antibiotics
• Positive test for hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at screening
• Positive test for human immunodeficiency virus type 1 (HIV-1) or HIV-2 antibodies at screening
• Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the planned first intake of study drug
• History of clinically significant allergies, especially known hypersensitivity or intolerance to sulfonamide or beta-lactam antibiotics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

Treatment Sequence 1 : ABAB

Experimental group

Description:

Participants will receive 140 milligram (mg) of ibrutinib administered as one IMBRUVICA 140-mg oral capsule (Treatment A) in Period 1, 140 mg of ibrutinib administered as one ibrutinib 140-mg oral tablet (Treatment B) in Period 2, then Treatment A in period 3 and then followed by Treatment B in Period 4. Each intervention Period will be separated by a washout period of 7-9 days.

Treatment:

Drug: IMBRUVICA

Drug: Ibrutinib

Treatment Sequence 2 : BABA

Experimental group

Description:

Participants will receive (Treatment B) Period 1, then Treatment A in Period 2, then Treatment B in Period 3 and then followed by Treatment A in Period 4. Each intervention Period will be separated by a washout period of 7-9 days.

Treatment:

Drug: IMBRUVICA

Drug: Ibrutinib