HealthyPhase 1NCT01428284
A Study to Assess the Effects of Multiple-Dose Probenecid on the Multiple-Dose Pharmacokinetics of Canagliflozin in Healthy Volunteers
A Phase 1 study testing Canagliflozin/Probenecid in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 1 site in United States.
Trial summary
The purpose of this study is to assess the effects of multiple doses of probenecid on the multiple-dose pharmacokinetics of canagliflozin and its metabolites in healthy volunteers. Safety and tolerability will also be assessed. Read more about this study
- Who is it for?
- Ages 15 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Canagliflozin/Probenecid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Oct 2011
- 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 15 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Inclusion Criteria: Body mass index (BMI) between 18 and 28 kg/m² inclusive and a body weight of not less than 50 kg. Exclusion Criteria:History of or current medical illness, abnormal values for hematology or clinical chemistry laboratory tests, or abnormal physical examination, vital signs or 12-lead electrocardiogram (ECG) deemed to be clinically significant by the Investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Fixed-Sequence Study to Assess the Effects of Multiple-Dose Probenecid on the Multiple-Dose Pharmacokinetics of Canagliflozin in Healthy Subjects
The purpose of this study is to assess the effects of multiple doses of probenecid on the multiple-dose pharmacokinetics of canagliflozin and its metabolites in healthy volunteers. Safety and tolerability will also be assessed.
Read the detailed description
This will be a single-center, open-label (identity of study treatments will be known to volunteers participating in the study as well as to study staff) study to assess the effects of multiple doses of probenecid on the multiple-dose pharmacokinetics of canagliflozin and its metabolites in healthy volunteers. The study will last up to approximately 49 days (includes a Screening Phase of up to 19 days, an Open-Label Treatment Phase of 20 days, and a Post-Treatment Phase of up to 7 to 10 days). Healthy volunteers will take orally (by mouth) one 300 mg canagliflozin tablet once daily and/or one 500-mg probenecid tablet twice daily in sequential order as follows: Days 1 to 14 (administration of canagliflozin alone) and Days 15 to 17 (administration of canagliflozin + twice-daily administration of probenecid). On days when both canagliflozin and probenecid are taken, both doses must be taken at approximately the same time.
- Conditions
- Healthy
- Being tested
- Canagliflozin/Probenecid
- Keywords
- Healthy Volunteers, Canagliflozin (JNJ-28431754), Pharmacokinetic, Probenecid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canagliflozin/ProbenecidDrug
Canagliflozin: Type = 1, unit = mg, number = 300, form = tablet, route = oral use. Probenicid: Type = 1, unit = mg, number = 500, form = tablet, route = oral use. One 300-mg canagliflozin tablet taken orally once daily on Days 1 to 14 (administration of canagliflozin alone) and on Days 15 to 17 (administration of canagliflozin + twice-daily administration of probenecid).
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | Canagliflozin/Probenecid Receives: Drug: Canagliflozin/Probenecid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of Canagliflozin (including canagliflozin metabolites)
Measured: Up to Day 18
Plasma concentrations of probenecid
Measured: Up to Day 17
Secondary outcomes (3)
Adverse Events
The number and type of adverse events
Measured: Up to 10 days following Day 18
Clinical Laboratory Tests
Clinically relevant changes occurring in laboratory safety parameters
Measured: Up to 10 days following Day 18
Vital Signs
Blood pressure and pulse
Measured: Up to 10 days following Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2011
- Study completionOct 2011
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research and Development, L.L.C Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428284
- Sponsor's protocol ID
- CR018736
- Other IDs
- 28431754DIA1048
- Status last verified
- Feb 2012
- First submitted
- 1 Sep 2011
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Fixed-Sequence Study to Assess the Effects of Multiple-Dose Probenecid on the Multiple-Dose Pharmacokinetics of Canagliflozin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01428284
- Acronym / sponsor ID
- CR018736
- Conditions
- Healthy
- Keywords
- Healthy Volunteers, Canagliflozin (JNJ-28431754), Pharmacokinetic, Probenecid
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 2 Sep 2011 (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 effects of multiple doses of probenecid on the multiple-dose pharmacokinetics of canagliflozin and its metabolites in healthy volunteers. Safety and tolerability will also be assessed.
Detailed description
This will be a single-center, open-label (identity of study treatments will be known to volunteers participating in the study as well as to study staff) study to assess the effects of multiple doses of probenecid on the multiple-dose pharmacokinetics of canagliflozin and its metabolites in healthy volunteers. The study will last up to approximately 49 days (includes a Screening Phase of up to 19 days, an Open-Label Treatment Phase of 20 days, and a Post-Treatment Phase of up to 7 to 10 days). Healthy volunteers will take orally (by mouth) one 300 mg canagliflozin tablet once daily and/or one 500-mg probenecid tablet twice daily in sequential order as follows: Days 1 to 14 (administration of canagliflozin alone) and Days 15 to 17 (administration of canagliflozin + twice-daily administration of probenecid). On days when both canagliflozin and probenecid are taken, both doses must be taken at approximately the same time.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: Canagliflozin/ProbenecidCanagliflozin/Probenecid |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Canagliflozin/ProbenecidCanagliflozin: Type = 1, unit = mg, number = 300, form = tablet, route = oral use. Probenicid: Type = 1, unit = mg, number = 500, form = tablet, route = oral use. One 300-mg canagliflozin tablet taken orally once daily on Days 1 to 14 (administration of canagliflozin alone) and on Days 15 to 17 (administration of canagliflozin + twice-daily administration of probenecid). | Drug | 001 |
Primary outcome
Plasma concentrations of Canagliflozin (including canagliflozin metabolites)
Time frame: Up to Day 18
Plasma concentrations of probenecid
Time frame: Up to Day 17
3 secondary outcomes
Adverse Events
Time frame: Up to 10 days following Day 18
Clinical Laboratory Tests
Time frame: Up to 10 days following Day 18
Vital Signs
Time frame: Up to 10 days following Day 18
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 17 Feb 2012.
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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.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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 Canagliflozin/Probenecid in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 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?
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 17 Feb 2012. 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?
Plasma concentrations of Canagliflozin (including canagliflozin metabolites) (time frame: Up to Day 18). The study lists 2 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 17 Feb 2012.