Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphocytic, Chronic, B-Cell

Leukemia, Lymphoid

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

Pharmaceutical Solutions

All Drugs and Chemicals

Adjuvants, Anesthesia

Central Nervous System Depressants

Psychotropic Drugs

Reproductive Control Agents

Cardiotonic Agents

Amino Acids

Midazolam

Ethinyl Estradiol

Levonorgestrel

Bupropion

Ibrutinib

Contraceptive Agents

Contraceptives, Oral

Ethinyl Estradiol-Norgestrel Combination

Estradiol

Estradiol 17 beta-cypionate

Estradiol 3-benzoate

Polyestradiol phosphate

Ethinyl estradiol, levonorgestrel drug combination

Anesthetics

Hypnotics and Sedatives

Anti-Anxiety Agents

Anesthetics, Intravenous

Anesthetics, General

GABA Modulators

Neurotransmitter Agents

Antidepressive Agents

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Contraceptive Agents, Hormonal

Contraceptive Agents, Female

Contraceptives, Oral, Hormonal

Estrogens

Hormones

Hormone Antagonists

Contraceptives, Oral, Combined

Tyrosine

Pre-treatment Phase: Participants will receive a single dose of oral contraceptive (OC) consisting of ethinylestradiol (EE) 30 microgram (mcg) and levonorgestrel (LN) 150 mcg on Study Day 1, and probe drugs (CYP) consisting of bupropion 75 milligram (mg) and midazolam 2 mg on Study Day 3, followed by a washout period from Study Days 4 to 7. Treatment Phase: Participants will receive ibrutinib 560 mg (4\*140 mg capsules) once daily (QD) on Days 8 to 26 along with midazolam 2 mg once orally on Study Day 8 (Cycle 1 Day 1), OC once orally on Study Day 22 (Cycle 1 Day 15; EE and LN), and bupropion 75 mg and midazolam 2 mg once orally on Study Day 24 (Cycle 1 Day 17). From Study Day 27 (Cycle 1 Day 20) and onwards participants will continue oral treatment with ibrutinib 420 mg (3\*140 mg capsules) or 560 mg QD (depending on the subtype of B-cell malignancy) up to the end of Cycle 6 (each cycle will consist of 28 days).

Ibrutinib capsule (at dose of 420 or 560 mg) will be taken orally QD.

Single dose of oral contraceptives (OC) (1 tablet containing 30 mcg EE and 150 mcg LN) will be taken orally on Study Days 1 and 22.

OC: Ethinylestradiol (EE) 30 mcg and Levonorgestrel (LN) 150 mcg

Bupropion 75 mg tablet as a part of CYP cocktail will be taken on Study Days 3 and 24.

Midazolam 2 mg (1 milliliter \[mL\]) oral solution will be taken on Study Days 3 and 24 (as a part of CYP cocktail) and on Study Day 8 (alone).

Janssen Research & Development, LLC Clinical Trial

The main purpose of this study is to evaluate the effects of repeat dosing of ibrutinib on the single-dose pharmacokinetics (PK) of oral contraceptives (OC - ethinylestradiol \[EE\] and levonorgestrel \[LN\]), the cytochrome P450 (CYP)2B6 probe bupropion and the CYP3A4 probe midazolam; and to evaluate the effects of single-dose ibrutinib on the single-dose PK of the CYP3A4 probe midazolam in female participants with B cell malignancy.

This is a multicenter study of ibrutinib (first-in-class, potent, covalently-binding inhibitor of Bruton's tyrosine kinase \[BTK\]) in female participants with B cell malignancy. The study consists of 3 phases: Screening Phase (up to 28 days), 7-day Pretreatment Phase (Days 1 to 7), Treatment Phase including PK assessment period (Days 8 to 26) and a Follow-up Phase (Day 27 to end of Cycle 6). The study procedures includes electrocardiogram (ECG), vital signs, blood samples withdrawal to evaluate PK and safety. The Antitumor activity will be assessed by means of computed tomography (CT) imaging and positron emission tomography (PET) scans. No formal statistical hypothesis will be tested. This is an estimation study designed to determine if an increase or decrease in exposure to OC or probe drugs occurs in the presence of ibrutinib.

A Study to Evaluate the Effect of Ibrutinib on the Pharmacokinetics of Oral Contraceptives, CYP2B6, and CYP3A4 Substrates in Female Participants With B Cell Malignancy

A Drug-Drug Interaction Study to Evaluate the Effect of Ibrutinib on the Pharmacokinetics of Oral Contraceptives, CYP2B6, and CYP3A4 Substrates in Female Subjects With B Cell Malignancy

The Cmax is the maximum observed plasma concentration.

The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'.

The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

Plasma concentrations of Ibrutinib and its Metabolite PCI-45227 will be measured.

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Blood samples for serum chemistry and hematology will be collected at predefined time points for clinical laboratory testing.

Triplicate ECG will be performed at screening and a single time point ECG will be performed at end of treatment visit.

Vital signs includes Temperature, Heart Rate, Respiratory Rate and Blood Pressure.

Janssen Research & Development, LLC

Spots Global Cancer Trial Database for oc: ethinylestradiol (ee) 30 mcg and levonorgestrel (ln) 150 mcg