HealthyPhase 1NCT01281579
A Single and Multiple Dose Study of Canagliflozin in Healthy Volunteers
A Phase 1 study testing Canagliflozin 100 mg, Canagliflozin 50 mg and Canagliflozin 300 mg in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to determine blood and urine concentrations of canagliflozin and glucose in healthy adult volunteers after administration of single and multiple doses of canagliflozin. 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?
- Canagliflozin 100 mg, Canagliflozin 50 mg and Canagliflozin 300 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Apr 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive, and a body weight of not less than 50 kg
Who cannot join
- History of or current clinically significant medical illness as determined by the Investigator
- History of clinically significant allergies, especially known hypersensitivity or intolerance to drugs or lactose
- Known allergy to canagliflozin or any of the excipients of the formulation of canagliflozin
About this study
Official title: An Open-Label, Randomized, Parallel-Group, Single-Center Study to Evaluate the Single and Multiple Dose Pharmacokinetic and Pharmacodynamic Characteristics of JNJ-28431754 (Canagliflozin) in Healthy Subjects
The purpose of this study is to determine blood and urine concentrations of canagliflozin and glucose in healthy adult volunteers after administration of single and multiple doses of canagliflozin.
Read the detailed description
This is an open-label (volunteers and study staff will know the name and dose of the treatment assigned), single-center study of canagliflozin (JNJ-28431754) in healthy adult volunteers. Canagliflozin (a sodium-glucose cotransporter 2-inhibitor) is currently under development to lower blood sugar levels in patients with Type 2 diabetes mellitus (T2DM). Healthy volunteers will take canagliflozin 50 mg, 100 mg, or 300 mg tablets, orally (by mouth), once daily on Day 1 and on Days 4 to 9. All study drug administration will occur at approximately the same time each morning with 240 mL of noncarbonated water and will be followed by a standardized breakfast within 10 minutes.
- Conditions
- Healthy
- Being tested
- Canagliflozin 100 mg, Canagliflozin 50 mg, Canagliflozin 300 mg
- Keywords
- Pharmacokinetics, Pharmacodynamics, Canagliflozin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canagliflozin 100 mgDrug
Tablets, oral, 100-mg, once daily on Day 1 and on Days 4 through 9.
Canagliflozin 50 mgDrug
Tablets, oral, 50-mg, once daily on Day 1 and on Days 4 through 9.
Canagliflozin 300 mgDrug
Tablets, oral, 300-mg, once daily on Day 1 and on Days 4 through 9.
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | Canagliflozin 50 mg Tablets oral 50-mg once daily on Day 1 and on Days 4 through 9. Receives: Drug: Canagliflozin 50 mg |
| 002 | Experimental | Canagliflozin 100 mg Tablets oral 100-mg once daily on Day 1 and on Days 4 through 9. Receives: Drug: Canagliflozin 100 mg |
| 003 | Experimental | Canagliflozin 300 mg Tablets oral 300-mg once daily on Day 1 and on Days 4 through 9. Receives: Drug: Canagliflozin 300 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentrations of canagliflozin
Measured: At protocol-specified times up to Day 14
Urine concentrations of canagliflozin
Measured: At protocol-specified times up to Day 11
Plasma glucose concentrations
Measured: At protocol-specified times up to Day 11
Urine glucose concentrations
Measured: At protocol-specified times up to Day 11
Secondary outcomes (2)
The number and type of adverse events reported
Measured: Up to 10 days after last dose" (last dose is given on Day 9)
Changes in hematology, chemistry and urinalysis parameters
Measured: Up to 10 days after last dose" (last dose is given on Day 9)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2011
- Study completionApr 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281579
- Sponsor's protocol ID
- CR017695
- Other IDs
- 28431754DIA1030
- Status last verified
- Nov 2012
- First submitted
- 20 Jan 2011
- Last updated
- 30 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Parallel-Group, Single-Center Study to Evaluate the Single and Multiple Dose Pharmacokinetic and Pharmacodynamic Characteristics of JNJ-28431754 (Canagliflozin) in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01281579
- Acronym / sponsor ID
- CR017695
- Conditions
- Healthy
- Keywords
- Pharmacokinetics, Pharmacodynamics, Canagliflozin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 24 Jan 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 determine blood and urine concentrations of canagliflozin and glucose in healthy adult volunteers after administration of single and multiple doses of canagliflozin.
Detailed description
This is an open-label (volunteers and study staff will know the name and dose of the treatment assigned), single-center study of canagliflozin (JNJ-28431754) in healthy adult volunteers. Canagliflozin (a sodium-glucose cotransporter 2-inhibitor) is currently under development to lower blood sugar levels in patients with Type 2 diabetes mellitus (T2DM). Healthy volunteers will take canagliflozin 50 mg, 100 mg, or 300 mg tablets, orally (by mouth), once daily on Day 1 and on Days 4 to 9. All study drug administration will occur at approximately the same time each morning with 240 mL of noncarbonated water and will be followed by a standardized breakfast within 10 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: Canagliflozin 50 mgCanagliflozin 50 mg Tablets oral 50-mg once daily on Day 1 and on Days 4 through 9. |
| 002 | Experimental | Drug: Canagliflozin 100 mgCanagliflozin 100 mg Tablets oral 100-mg once daily on Day 1 and on Days 4 through 9. |
| 003 | Experimental | Drug: Canagliflozin 300 mgCanagliflozin 300 mg Tablets oral 300-mg once daily on Day 1 and on Days 4 through 9. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers with a body mass index (BMI, a measure of a person's weight in relation to height) between 18 and 30 kg/m2, inclusive, and a body weight of not less than 50 kg
Key exclusion criteria (3 listed)
- History of or current clinically significant medical illness as determined by the Investigator
- History of clinically significant allergies, especially known hypersensitivity or intolerance to drugs or lactose
- Known allergy to canagliflozin or any of the excipients of the formulation of canagliflozin
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 100 mgTablets, oral, 100-mg, once daily on Day 1 and on Days 4 through 9. | Drug | 002 |
| Canagliflozin 50 mgTablets, oral, 50-mg, once daily on Day 1 and on Days 4 through 9. | Drug | 001 |
| Canagliflozin 300 mgTablets, oral, 300-mg, once daily on Day 1 and on Days 4 through 9. | Drug | 003 |
Primary outcome
Plasma concentrations of canagliflozin
Time frame: At protocol-specified times up to Day 14
Urine concentrations of canagliflozin
Time frame: At protocol-specified times up to Day 11
Plasma glucose concentrations
Time frame: At protocol-specified times up to Day 11
Urine glucose concentrations
Time frame: At protocol-specified times up to Day 11
2 secondary outcomes
The number and type of adverse events reported
Time frame: Up to 10 days after last dose" (last dose is given on Day 9)
Changes in hematology, chemistry and urinalysis parameters
Time frame: Up to 10 days after last dose" (last dose is given on Day 9)
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 30 Nov 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 & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Canagliflozin 100 mg, Canagliflozin 50 mg and Canagliflozin 300 mg in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 1 inclusion and 3 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 30 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
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 (time frame: At protocol-specified times up to Day 14). 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 30 Nov 2012.