- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02390609
A Crossover Study to Evaluate the Bioavailability of Ibrutinib Suspension and Sprinkle Formulations Compared to Capsules in Healthy Adults
December 21, 2015 updated by: Janssen Research & Development, LLC
Open-Label, Randomized, Parallel Group, 3- or 4-Way Crossover Bioavailability Study of Ibrutinib Suspension and Sprinkle Formulations Compared to Capsules in Healthy Adults
The purpose of this study is to assess the relative bioavailability (the extent to which a drug or other substance becomes available to the body) of ibrutinib in healthy adults following single oral dose administration of suspension and sprinkle formulations under fed and fasted conditions compared with capsules under fasted conditions.
Study Overview
Status
Completed
Conditions
Detailed Description
This is an open-label (all people know the identity of the intervention), randomized (study medication assigned to participants by chance), 3- or 4-way crossover (participants may receive different interventions sequentially during the trial), and single-center study of ibrutinib.
The duration of study will be approximately 67 to 83 days per participant.
The study consists of 3 parts: Screening (28 days before study commences on Day 1); Open-label Treatment (consists of 6 treatments, either Ibrutinib capsule or suspension or sprinkle capsule granules under fed or fasted condition), in subsequent 3 periods for Group 1 and 4 periods for Group 2, each separated with washout period of 7 (plus [+] / minus [-] 2) days; and follow up Phase (up to 10 + / - 2 days after last study drug administration).
All the eligible participants will be randomly assigned to 1 of the 6 (Group 1) or 4 (Group 2) treatment sequences.
In fasted conditions, study drug will be administered following a 10-hour overnight fast.
In fed conditions, participants will also fast from food for 10 hours, but will consume a high fat breakfast within a 30-minute period.
Study drug will be administered 2 hours after the breakfast.
Participants will not be allowed to have food until 4 hours of drug administration.
Blood samples will be collected for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment.
Relative bioavailability of Ibrutinib will be evaluated primarily.
Participants' safety will be monitored throughout the study.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Antwerpen, Belgium
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
- If a woman, must not be of childbearing potential: postmenopausal ( greater than [>] 45 years of age with amenorrhea for at least 2 years, or any age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) >40 International units [IU]/ Liter [L]); surgically sterile
- If a woman, must have a negative serum β-human chorionic gonadotropin (hCG) pregnancy test at Screening and a negative urine pregnancy test on Day-1 of the each treatment period
- If a man who is sexually active with a woman of childbearing potential and has not had a vasectomy, must agree to use an adequate contraception method as deemed appropriate by the investigator (eg, vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
- Body mass index (BMI; weight [kg]/height^2 [m]^2) between 18 and 30 Kilogram (kg)/ meter^2 (m^2) (inclusive), and body weight not less than 50 kg
Exclusion Criteria:
- History of or 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 (creatinine clearance below 60 milliliter [mL]/ minute [min]), 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, coagulation, clinical chemistry, 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
- Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for paracetamol and hormonal replacement therapy within 14 days before the first dose of the study drug is scheduled until completion of the study
- History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (4th edition) (DSM-IV) criteria within 2 years before Screening or positive test result(s) for alcohol and/or drugs of abuse (such as barbiturates, opiates, cocaine, cannabinoids, amphetamines, and benzodiazepines) at Screening and Day-1 of the each treatment period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1: Sequence 1 (ABC)
Participants will receive Treatment A (Ibrutinib 560 milligram [mg] capsules [reference] under fasted conditions) in Period 1; followed by Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 2; followed by Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 3. A washout period of 7 (plus [+] / minus [-] 2) days will be maintained between each treatment period.
|
Participants will receive Ibrutinib 560 milligram (mg) (4*140 mg) capsule as Treatment A under fasted conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg suspension as Treatment B under fasted conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg suspension as Treatment C under fed (high-fat) conditions in one of the treatment periods.
|
Experimental: Group 1: Sequence 2 (BCA)
Participants will receive Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 1; followed by Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 2; followed by Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 3. A washout period of 7 (+/- 2) days will be maintained between each treatment period.
|
Participants will receive Ibrutinib 560 milligram (mg) (4*140 mg) capsule as Treatment A under fasted conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg suspension as Treatment B under fasted conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg suspension as Treatment C under fed (high-fat) conditions in one of the treatment periods.
|
Experimental: Group 1: Sequence 3 (CAB)
Participants will receive Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 1; followed by Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 2; followed by Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 3. A washout period of 7 (+/- 2) days will be maintained between each treatment period.
|
Participants will receive Ibrutinib 560 milligram (mg) (4*140 mg) capsule as Treatment A under fasted conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg suspension as Treatment B under fasted conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg suspension as Treatment C under fed (high-fat) conditions in one of the treatment periods.
|
Experimental: Group 1: Sequence 4 (ACB)
Participants will receive Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 1; followed by Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 2; followed by Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 3. A washout period of 7 (+/- 2) days will be maintained between each treatment period.
|
Participants will receive Ibrutinib 560 milligram (mg) (4*140 mg) capsule as Treatment A under fasted conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg suspension as Treatment B under fasted conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg suspension as Treatment C under fed (high-fat) conditions in one of the treatment periods.
|
Experimental: Group 1: Sequence 5 (BAC)
Participants will receive Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 1; followed by Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 2; followed by Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 3. A washout period of 7 (+/- 2) days will be maintained between each treatment period.
|
Participants will receive Ibrutinib 560 milligram (mg) (4*140 mg) capsule as Treatment A under fasted conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg suspension as Treatment B under fasted conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg suspension as Treatment C under fed (high-fat) conditions in one of the treatment periods.
|
Experimental: Group 1: Sequence 6 (CBA)
Participants will receive Treatment C (Ibrutinib 560 mg suspension under fed conditions) in Period 1; followed by Treatment B (Ibrutinib 560 mg suspension under fasted conditions) in Period 2; followed by Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 3. A washout period of 7 (+/- 2) days will be maintained between each treatment period.
|
Participants will receive Ibrutinib 560 milligram (mg) (4*140 mg) capsule as Treatment A under fasted conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg suspension as Treatment B under fasted conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg suspension as Treatment C under fed (high-fat) conditions in one of the treatment periods.
|
Experimental: Group 2: Sequence 1 (AFDE)
Participants will receive Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 1; followed by Treatment F (Ibrutinib 560 mg sprinkle capsule granules suspended in water under fasted conditions) in Period 2; followed by Treatment D (Ibrutinib 560 mg sprinkle capsule granules under fasted conditions) in Period 3; followed by Treatment E (Ibrutinib 560 mg sprinkle capsule granules under fed conditions) in Period 4. A washout period of 7 (+/- 2) days will be maintained between each treatment period.
|
Participants will receive Ibrutinib 560 milligram (mg) (4*140 mg) capsule as Treatment A under fasted conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment D under fasted conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment E under fed (high-fat) conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg sprinkle capsule granules suspended in water as Treatment F under fasted conditions in one of the treatment periods.
|
Experimental: Group 2: Sequence 2 (DAEF)
Participants will receive Treatment D (Ibrutinib 560 mg sprinkle capsule granules under fasted conditions) in Period 1; followed by Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 2; followed by Treatment E (Ibrutinib 560 mg sprinkle capsule granules under fed conditions) in Period 3; followed by Treatment F (Ibrutinib 560 mg sprinkle capsule granules suspended in water under fasted conditions) in Period 4. A washout period of 7 (+/- 2) days will be maintained between each treatment period.
|
Participants will receive Ibrutinib 560 milligram (mg) (4*140 mg) capsule as Treatment A under fasted conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment D under fasted conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment E under fed (high-fat) conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg sprinkle capsule granules suspended in water as Treatment F under fasted conditions in one of the treatment periods.
|
Experimental: Group 2: Sequence 3 (EDFA)
Participants will receive Treatment E (Ibrutinib 560 mg sprinkle capsule granules under fed conditions) in Period 1; followed by Treatment D (Ibrutinib 560 mg sprinkle capsule granules under fasted conditions) in Period 2; followed by Treatment F (Ibrutinib 560 mg sprinkle capsule granules suspended in water under fasted conditions) in Period 3; followed by Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 4. A washout period of 7 (+/- 2) days will be maintained between each treatment period.
|
Participants will receive Ibrutinib 560 milligram (mg) (4*140 mg) capsule as Treatment A under fasted conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment D under fasted conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment E under fed (high-fat) conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg sprinkle capsule granules suspended in water as Treatment F under fasted conditions in one of the treatment periods.
|
Experimental: Group 2: Sequence 4 (FEAD)
Participants will receive Treatment F (Ibrutinib 560 mg sprinkle capsule granules suspended in water under fasted conditions) in Period 1; followed by Treatment E (Ibrutinib 560 mg sprinkle capsule granules under fed conditions) in Period 2; followed by Treatment A (Ibrutinib 560 mg capsules [reference] under fasted conditions) in Period 3; followed by Treatment D (Ibrutinib 560 mg sprinkle capsule granules under fasted conditions) in Period 4. A washout period of 7 (+/- 2) days will be maintained between each treatment period.
|
Participants will receive Ibrutinib 560 milligram (mg) (4*140 mg) capsule as Treatment A under fasted conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment D under fasted conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment E under fed (high-fat) conditions in one of the treatment periods.
Participants will receive Ibrutinib 560 mg sprinkle capsule granules suspended in water as Treatment F under fasted conditions in one of the treatment periods.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Plasma Concentration (Cmax) of Ibrutinib
Time Frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
The Cmax is the maximum observed plasma concentration of Ibrutinib.
|
Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
Time to Reach the Maximum Plasma Concentration (Tmax) of Ibrutinib
Time Frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
The Tmax is the time to reach the maximum observed plasma concentration of Ibrutinib.
|
Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
Area Under the Plasma Concentration-Time Curve From 0 to 24 Hours (AUC[0-24]) Post Dose of Ibrutinib
Time Frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
The AUC (0-24hrs) is the area under the plasma Ibrutinib concentration-time curve from 0 to 24 hours post dosing.
|
Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Observed Quantifiable Concentration (AUC [0-last]) of Ibrutinib
Time Frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
The AUC (0-last) is the area under the plasma Ibrutinib concentration-time curve from time 0 to time of the last observed quantifiable concentration (C[last]).
|
Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
Area Under the Plasma Concentration-Time Curve From 0 to Infinite Time (AUC[0-infinity]) Post Dose of Ibrutinib
Time Frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
The AUC (0-infinity) is the area under the plasma Ibrutinib concentration-time curve from time 0 to infinite time, calculated as the sum of AUC (0-last) and C(last)/lambda(z), in which AUC(0-last) is area under the plasma Ibrutinib concentration-time curve from time zero to time of the last quantifiable concentration, C(last) is the last observed quantifiable concentration and lambda(z) is elimination rate constant.
|
Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
Percentage of Area Under the Plasma Concentration-Time Curve Obtained by Extrapolation (%AUC[infinity,ex])
Time Frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
The %AUC(infinity,ex) is calculated by dividing the difference of AUC(0-infinity) and AUC(0-last) by AUC(0-infinity) and then multiplying by 100, (AUC[0-infinity] - AUC[0-last])*100/AUC[0-infinity].
|
Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
Terminal Half-life (t[1/2]) of Ibrutinib
Time Frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
The t(1/2) is defined as 0.693/Lambda (z).
|
Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
Elimination Rate Constant (Lambda [z]) of Ibrutinib
Time Frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.
|
Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
Adjusted Coefficient of Determination (r^2 [adjusted])
Time Frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
The r^2 [adjusted] for the number of points used in the estimation of lambda[z].
|
Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
Relative Bioavailability (Frel) of Ibrutinib
Time Frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
The Frel will be calculated as individual Cmax and AUC treatment ratios (for the comparison of food effect).
Calculated as: [(AUC[0-infinity][test]/AUC[0-infinity][ref])*(Dose[ref]/Dose[test])]*100.
|
Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
Metabolite to Parent Ratio for Maximum Plasma Concentration (Cmax) of Ibrutinib
Time Frame: Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
Metabolite to parent drug ratio for maximum observed plasma concentration of Ibrutinib.
|
Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose on Day 1 of each period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with Adverse Events (AEs) and Serious AEs
Time Frame: Screening up to follow-up (10 plus [+] / minus [-] 2 days after last dose administration)
|
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
|
Screening up to follow-up (10 plus [+] / minus [-] 2 days after last dose administration)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Janssen Research & Development Clinical Trial, Janssen Research & Development
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2015
Primary Completion (Actual)
November 1, 2015
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
March 11, 2015
First Submitted That Met QC Criteria
March 11, 2015
First Posted (Estimate)
March 17, 2015
Study Record Updates
Last Update Posted (Estimate)
December 23, 2015
Last Update Submitted That Met QC Criteria
December 21, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CR106946
- 2015-000155-25 (EudraCT Number)
- PCI-32765CLL1015 (Other Identifier: Janssen Research & Development, LLC)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Ibrutinib (Treatment A) [Reference]
-
Janssen Research & Development, LLCCompleted
-
University Children's Hospital BaselPermamed AG, Switzerland; Galvita AG, SwitzerlandCompleted
-
Janssen Infectious Diseases BVBACompletedHealthy | Biological AvailabilityNetherlands
-
Janssen Research & Development, LLCPharmacyclics LLC.Completed
-
Assistance Publique - Hôpitaux de ParisUniversity Hospital, Clermont-Ferrand; Rennes University Hospital; Nantes University...UnknownInflammatory Pulp Diseases Related to Carious TeethFrance
-
Chiesi Farmaceutici S.p.A.Quintiles, Inc.Completed
-
Janssen Research & Development, LLCCompleted
-
AstraZenecaCompleted
-
Stichting Hemato-Oncologie voor Volwassenen NederlandNordic CLL Study GroupActive, not recruitingChronic Lymphocytic Leukemia in Relapse | Chronic Lymphocytic Leukemia in RemissionNetherlands, Belgium, Denmark, Finland, Norway, Sweden
-
Merck KGaA, Darmstadt, GermanyCompleted