HealthyPhase 1NCT01626651
A Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Ibrutinib in Healthy Participants
A Phase 1 study testing Ibrutinib and Ketoconazole in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
Trial summary
The purpose of this study is to assess the potential effects of ketoconazole on the pharmacokinetics of ibrutinib in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ibrutinib and Ketoconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Aug 2012
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) between 18 and 30 kg/m2, and body weight not less than 50 kg
- Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
- Non-smoker
- Must agree to use an adequate contraception method during the study and minimally 3 months after the last dose of ibrutinib, and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
- Signed an informed consent document
Who cannot join
- History of or current clinically significant medical illness
- Clinically significant abnormal physical examination, vital signs or electrocardiogram (ECG)
- Clinically significant abnormal values for laboratorial tests
- Use of any prescription or nonprescription medication, except for acetaminophen, within 3 days before the first dose of the study drug is schedule
- History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 2 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Sequential Design Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Ibrutinib in Healthy Subjects
The purpose of this study is to assess the potential effects of ketoconazole on the pharmacokinetics of ibrutinib in healthy participants.
Read the detailed description
This is a single-center, open-label (all people know the identity of the intervention), sequential design study in healthy men. All participants will receive ibrutinib on Day 1 and ibrutinib in combination with ketoconazole on Day 7. Food will be restricted from the evening before dosing until 4 hours after dosing on Days 1 and 7. Following an overnight fast, ketoconazole will be given on Days 4 to 6, 1 hour prior to ibrutinib dosing on Day 7, and again on Days 8 and 9. All ibrutinib and ketoconazole doses will be administered with water. The participants will leave the study center on Day 10.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbrutinibDrug
A single oral dose of 120 mg ibrutinib (3 x 40 mg capsules) on Day 1, and 40 mg (1x 40 mg capsule) ibrutinib on Day 7.
KetoconazoleDrug
Ketoconazole (400 mg [2 x 200 mg] once daily) will be orally administered on Days 4, 5, 6, 7, 8 and 9.
| Study group | Role | What they receive |
|---|---|---|
| Ibrutinib and Ketoconazole | Experimental | Not described Receives: Drug: Ibrutinib; Drug: Ketoconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ibrutinib plasma concentrations after administration on Day 1
Measured: over 72 hours after dosing on Day 1
Ibrutinib plasma concentrations after administration on Day 7
Measured: over 72 hours after dosing on Day 7
Metabolite PCI-45227 plasma concentrations after administration on Day 1
Measured: over 72 hours after dosing on Day 1
Metabolite PCI-45227 plasma concentrations after administration on Day 7
Measured: over 72 hours after dosing on Day 7
Secondary outcomes (5)
Ibrutinib urine concentrations after administration on Day 1
Measured: over 72 hours after dosing on Day 1
Ibrutinib urine concentrations after administration on Day 7
Measured: over 72 hours after dosing on Day 7
Metabolite PCI-45227 urine concentrations after administration on Day 1
Measured: over 72 hours after dosing on Day 1
Metabolite PCI-45227 urine concentrations after administration on Day 7
Measured: over 72 hours after dosing on Day 7
Incidence of adverse events as a measure of safety and tolerability
Measured: Approximately 41 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626651
- Sponsor's protocol ID
- CR100870
- Other IDs
- PCI-32765CLL1002
- Status last verified
- Jun 2013
- First submitted
- 18 Jun 2012
- Last updated
- 19 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Sequential Design Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Ibrutinib in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01626651
- Acronym / sponsor ID
- CR100870
- Conditions
- Healthy
- Keywords
- Healthy, Ketoconazole, Ibrutinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 25 Jun 2012 (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 assess the potential effects of ketoconazole on the pharmacokinetics of ibrutinib in healthy participants.
Detailed description
This is a single-center, open-label (all people know the identity of the intervention), sequential design study in healthy men. All participants will receive ibrutinib on Day 1 and ibrutinib in combination with ketoconazole on Day 7. Food will be restricted from the evening before dosing until 4 hours after dosing on Days 1 and 7. Following an overnight fast, ketoconazole will be given on Days 4 to 6, 1 hour prior to ibrutinib dosing on Day 7, and again on Days 8 and 9. All ibrutinib and ketoconazole doses will be administered with water. The participants will leave the study center on Day 10.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ibrutinib and Ketoconazole | Experimental | Drug: Ibrutinib, Drug: Ketoconazole |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Body mass index (BMI) between 18 and 30 kg/m2, and body weight not less than 50 kg
- Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
- Non-smoker
- Must agree to use an adequate contraception method during the study and minimally 3 months after the last dose of ibrutinib, and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
- Signed an informed consent document
Key exclusion criteria (5 listed)
- History of or current clinically significant medical illness
- Clinically significant abnormal physical examination, vital signs or electrocardiogram (ECG)
- Clinically significant abnormal values for laboratorial tests
- Use of any prescription or nonprescription medication, except for acetaminophen, within 3 days before the first dose of the study drug is schedule
- History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 2 years
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 |
|---|---|---|
| IbrutinibA single oral dose of 120 mg ibrutinib (3 x 40 mg capsules) on Day 1, and 40 mg (1x 40 mg capsule) ibrutinib on Day 7. | Drug | Ibrutinib and Ketoconazole |
| KetoconazoleKetoconazole (400 mg [2 x 200 mg] once daily) will be orally administered on Days 4, 5, 6, 7, 8 and 9. | Drug | Ibrutinib and Ketoconazole |
Primary outcome
Ibrutinib plasma concentrations after administration on Day 1
Time frame: over 72 hours after dosing on Day 1
Ibrutinib plasma concentrations after administration on Day 7
Time frame: over 72 hours after dosing on Day 7
Metabolite PCI-45227 plasma concentrations after administration on Day 1
Time frame: over 72 hours after dosing on Day 1
Metabolite PCI-45227 plasma concentrations after administration on Day 7
Time frame: over 72 hours after dosing on Day 7
5 secondary outcomes
Ibrutinib urine concentrations after administration on Day 1
Time frame: over 72 hours after dosing on Day 1
Ibrutinib urine concentrations after administration on Day 7
Time frame: over 72 hours after dosing on Day 7
Metabolite PCI-45227 urine concentrations after administration on Day 1
Time frame: over 72 hours after dosing on Day 1
Metabolite PCI-45227 urine concentrations after administration on Day 7
Time frame: over 72 hours after dosing on Day 7
Incidence of adverse events as a measure of safety and tolerability
Time frame: Approximately 41 days
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 19 Jun 2013.
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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 Ketoconazole in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
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 19 Jun 2013. 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 United States. 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?
Ibrutinib plasma concentrations after administration on Day 1 (time frame: over 72 hours after dosing on Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2013.