HealthyPhase 1NCT02638116

A Drug Interaction Study to Assess the Effect of Omeprazole on the Pharmacokinetics of Ibrutinib in Healthy Adults

A Phase 1 study testing Ibrutinib and Omeprazole in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to evaluate the Effect of Omeprazole on the Pharmacokinetics of Ibrutinib in Healthy Adults. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Ibrutinib and Omeprazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteBelgium
Study dates: Jan 2016to Mar 2016
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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
Willing to adhere to the prohibitions and restrictions specified in the protocol
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 (example, 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

Who cannot join

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 (5th 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

Trial locations and contacts

1 site in 1 country.

Belgium1 site

Study site
Antwerp

Other trials in Belgium

About this study

Official title: Open-Label, Sequential-Design Drug Interaction Study of the Effect of Omeprazole on the Pharmacokinetics of Ibrutinib in Healthy Adults

The purpose of this study is to evaluate the Effect of Omeprazole on the Pharmacokinetics of Ibrutinib in Healthy Adults.

Read the detailed description

This is an open-label (all people know the identity of the intervention), single-center, sequential-design drug interaction study to assess the effect of omeprazole on pharmacokinetics of ibrutinib and metabolite PCI-45227 in healthy participants. The study mainly consists of 3 Phases: Screening Phase (within 21 days prior to the first dose of study medication), treatment Phase, and a follow up Phase (10 to 12 days after the last dose of study medication). In the treatment Phase, participants will receive Ibrutinib 560 milligram (mg) orally (4 x 140 mg capsules) on Day 1 and Day 7. participants will receive Omeprazole at a dose of 40 mg tablets orally once on Days 3 through 7. The total duration of study for each participant will be approximately for 29 to 32 days. Blood samples will be collected for evaluation of pharmacokinetics of Ibrutinib. Participants' safety will be monitored throughout the study.

Conditions: Healthy
Being tested: Ibrutinib, Omeprazole
Keywords: Ibrutinib, Proton pump inhibitors, Pharmacokinetics, Drug Interaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IbrutinibDrug
Ibrutinib will be administered at a dose of 560 milligram (mg) orally (4 x 140 mg capsules) on Day 1 and Day 7.
OmeprazoleDrug
Omeprazole will be administered at dose of 40 mg tablets orally once daily from Day 3 to Day 7.

Study groups in NCT02638116
Study group	Role	What they receive
Ibrutinib + Omeprazole	Experimental	Participants will receive a dose of Ibrutinib 560 milligram (mg) orally (4 x 140 mg capsules) on Day 1 and Day 7 and Omeprazole at a dose of 40 mg tablets orally once on Days 3 through 7. Receives: Drug: Ibrutinib; Drug: Omeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Plasma Concentration (Cmax) of Ibrutinib
The Cmax is the maximum observed plasma concentration of Ibrutinib.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose on Day 1 and Day 7
Time to Reach the Maximum Plasma Concentration (Tmax) of Ibrutinib
The Tmax is the time to reach the maximum observed plasma concentration of Ibrutinib.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose on Day 1 and Day 7
Area Under the Plasma Concentration-Time Curve From 0 to 48 Hours (AUC[0-48]) Post Dose of Ibrutinib
The AUC (0-48hrs) is the area under the plasma Ibrutinib concentration-time curve from 0 to 48 hours post dosing.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose on Day 1 and Day 7
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Observed Quantifiable Concentration (AUC [0-last]) of Ibrutinib
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]).
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose on Day 1 and Day 7
Metabolite to Parent (M/P) Ratio of Ibrutinib
Ratio of ibrutinib metabolite concentration to parent compound (ibrutinib) concentration will be assessed.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose on Day 1 and Day 7

Secondary outcomes (5)

Maximum Plasma Concentration (Cmax) of PCI-45227
The Cmax is the maximum observed plasma concentration of PCI-45227.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose on Day 1 and Day 7
Time to Reach the Maximum Plasma Concentration (Tmax) of PCI-45227
The Tmax is the time to reach the maximum observed plasma concentration of PCI-45227.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose on Day 1 and Day 7
Area Under the Plasma Concentration-Time Curve From 0 to 48 Hours (AUC[0-48]) Post Dose of PCI-45227
The AUC (0-48hrs) is the area under the plasma PCI-45227 concentration-time curve from 0 to 48 hours post dosing.
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose on Day 1 and Day 7
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Observed Quantifiable Concentration (AUC [0-last]) of PCI-45227
The AUC (0-last) is the area under the plasma PCI-45227 concentration-time curve from time 0 to time of the last observed quantifiable concentration (C[last]).
Measured: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose on Day 1 and Day 7
Number of Participants with Adverse Events (AEs) and Serious AEs
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
Measured: Screening up to follow-up (10 plus [+] / minus [-] 2 days after last dose administration)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2016Mar 2016

First posted22 Dec 2015 (estimated)
Study startJan 2016
Primary completionMar 2016
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02638116
Sponsor's protocol ID: CR108106
Other IDs: 2015-005015-32, PCI-32765CLL1005, 2015
Status last verified: Jan 2025
First submitted: 18 Dec 2015
Last updated: 3 Feb 2025
Results posted: No
Data monitoring committee: No

Publications

de Jong J, Haddish-Berhane N, Hellemans P, Jiao J, Sukbuntherng J, Ouellet D. The pH-altering agent omeprazole affects rate but not the extent of ibrutinib exposure. Cancer Chemother Pharmacol. 2018 Aug;82(2):299-308. doi: 10.1007/s00280-018-3613-9. Epub 2018 Jun 7.
PubMed 29882017

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-Label, Sequential-Design Drug Interaction Study of the Effect of Omeprazole on the Pharmacokinetics of Ibrutinib in Healthy Adults
ClinicalTrials.gov ID: NCT02638116
Acronym / sponsor ID: CR108106
Conditions: Healthy
Keywords: Ibrutinib, Proton pump inhibitors, Pharmacokinetics, Drug Interaction
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
Study start: Jan 2016
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 22 Dec 2015 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the Effect of Omeprazole on the Pharmacokinetics of Ibrutinib in Healthy Adults.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Ibrutinib + Omeprazole	Experimental	Drug: Ibrutinib, Drug: OmeprazoleParticipants will receive a dose of Ibrutinib 560 milligram (mg) orally (4 x 140 mg capsules) on Day 1 and Day 7 and Omeprazole at a dose of 40 mg tablets orally once on Days 3 through 7.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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
Willing to adhere to the prohibitions and restrictions specified in the protocol
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 (example, 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

Key exclusion criteria (5 listed)

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 (5th 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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IbrutinibIbrutinib will be administered at a dose of 560 milligram (mg) orally (4 x 140 mg capsules) on Day 1 and Day 7.	Drug	Ibrutinib + Omeprazole
OmeprazoleOmeprazole will be administered at dose of 40 mg tablets orally once daily from Day 3 to Day 7.	Drug	Ibrutinib + Omeprazole

Primary outcome

Maximum Plasma Concentration (Cmax) of Ibrutinib
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose on Day 1 and Day 7
The Cmax is the maximum observed plasma concentration of Ibrutinib.
Time to Reach the Maximum Plasma Concentration (Tmax) of Ibrutinib
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose on Day 1 and Day 7
The Tmax is the time to reach the maximum observed plasma concentration of Ibrutinib.
Area Under the Plasma Concentration-Time Curve From 0 to 48 Hours (AUC[0-48]) Post Dose of Ibrutinib
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose on Day 1 and Day 7
The AUC (0-48hrs) is the area under the plasma Ibrutinib concentration-time curve from 0 to 48 hours post dosing.
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, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose on Day 1 and Day 7
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]).
Metabolite to Parent (M/P) Ratio of Ibrutinib
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose on Day 1 and Day 7
Ratio of ibrutinib metabolite concentration to parent compound (ibrutinib) concentration will be assessed.

5 secondary outcomes

Maximum Plasma Concentration (Cmax) of PCI-45227
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose on Day 1 and Day 7
Time to Reach the Maximum Plasma Concentration (Tmax) of PCI-45227
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose on Day 1 and Day 7
Area Under the Plasma Concentration-Time Curve From 0 to 48 Hours (AUC[0-48]) Post Dose of PCI-45227
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose on Day 1 and Day 7
Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Observed Quantifiable Concentration (AUC [0-last]) of PCI-45227
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose on Day 1 and Day 7
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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
Derived from this study: PubMed 29882017de Jong J, Haddish-Berhane N, Hellemans P, Jiao J, Sukbuntherng J, Ouellet D. The pH-altering agent omeprazole affects rate but not the extent of ibrutinib exposure. Cancer Chemother Pharmacol. 2018 Aug;82(2):299-308. doi: 10.1007/s00280-018-3613-9. Epub 2018 Jun 7.

Related trials for Healthy

Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janssen Research & Development, LLC Clinical Trial study director

Janssen Research & Development, LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ibrutinib and Omeprazole in people with Healthy, run by Janssen Research & Development, LLC at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Plasma Concentration (Cmax) of Ibrutinib (time frame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 hours post-dose on Day 1 and Day 7). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02638116, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.