HealthyPhase 1NCT01343290
The Effect of Food on the Administration of Canagliflozin in Healthy Adult Volunteers
A Phase 1 study testing Canagliflozin in people with Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to assess the effect of food on the absorption of canagliflozin in the body when canagliflozin is taken with and without food by healthy volunteers 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Apr 2011to Jun 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 between 18 and 30 kg/m2 (inclusive) and body weight not less than 50 kg
Who cannot join
- of or current medical illness deemed clinically significant by the Investigator (study physician)
About this study
Official title: A Single-Dose, Open-Label, Randomized, 2-Period, 2-Sequence, Crossover Study to Determine the Effect of Food Coadministration on the Pharmacokinetics of 300 mg Canagliflozin in Healthy Subjects
The purpose of this study is to assess the effect of food on the absorption of canagliflozin in the body when canagliflozin is taken with and without food by healthy volunteers
Read the detailed description
This is a single-center, single-dose, open-label (volunteers will know the identity of assigned treatment), randomized (one of 2 study drug sequences assigned by chance) study to evaluate the oral bioavailability (the degree to which the drug is absorbed in the body when taken orally by mouth) of canagliflozin when taken with and without food in healthy volunteers. Healthy Volunteers will take 1 canagliflozin tablet orally for 1 day in 2 treatment periods (canagliflozin will be taken with food in 1 treatment period and canagliflozin will be taken without food in 1 treatment period); the 2 treatment periods will be separated by a 10- to 14-day washout period.
- Conditions
- Healthy
- Being tested
- Canagliflozin
- Keywords
- Canagliflozin (JNJ-28431754), Pharmacokinetic, Oral Bioavailability, Food effect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanagliflozinDrug
Type = 1, unit = mg, number = 300, form = tablet, route = oral use. Single tablet taken with or without a meal during 2 treatment periods
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | Canagliflozin Type = 1 unit = mg number = 300 form = tablet route = oral use. Single tablet taken with or without a meal during 2 treatment periods Receives: Drug: Canagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of canagliflozin in plasma samples
Measured: For up to 8 days
Secondary outcomes (4)
Adverse events reported
Measured: Up to approximately 34 days
Vital signs measurements
Measured: Up to approximately 34 days
Results from clinical chemistries performed
Measured: Up to approximately 34 days
Results from 12-lead ECGs performed
Measured: Up to approximately 34 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionJun 2011
- Study completionJun 2011
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.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 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
- NCT01343290
- Sponsor's protocol ID
- CR018016
- Other IDs
- 284317541043
- Status last verified
- Sep 2012
- First submitted
- 1 Apr 2011
- Last updated
- 2 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Devineni D, Manitpisitkul P, Murphy J, Stieltjes H, Ariyawansa J, Di Prospero NA, Rothenberg P. Effect of food on the pharmacokinetics of canagliflozin, a sodium glucose co-transporter 2 inhibitor, and assessment of dose proportionality in healthy participants. Clin Pharmacol Drug Dev. 2015 Jul;4(4):279-86. doi: 10.1002/cpdd.151. Epub 2014 Dec 11.
PubMed 27136908
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose, Open-Label, Randomized, 2-Period, 2-Sequence, Crossover Study to Determine the Effect of Food Coadministration on the Pharmacokinetics of 300 mg Canagliflozin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01343290
- Acronym / sponsor ID
- CR018016
- Conditions
- Healthy
- Keywords
- Canagliflozin (JNJ-28431754), Pharmacokinetic, Oral Bioavailability, Food effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 28 Apr 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 effect of food on the absorption of canagliflozin in the body when canagliflozin is taken with and without food by healthy volunteers
Detailed description
This is a single-center, single-dose, open-label (volunteers will know the identity of assigned treatment), randomized (one of 2 study drug sequences assigned by chance) study to evaluate the oral bioavailability (the degree to which the drug is absorbed in the body when taken orally by mouth) of canagliflozin when taken with and without food in healthy volunteers. Healthy Volunteers will take 1 canagliflozin tablet orally for 1 day in 2 treatment periods (canagliflozin will be taken with food in 1 treatment period and canagliflozin will be taken without food in 1 treatment period); the 2 treatment periods will be separated by a 10- to 14-day washout period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: CanagliflozinCanagliflozin Type = 1 unit = mg number = 300 form = tablet route = oral use. Single tablet taken with or without a meal during 2 treatment periods |
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 between 18 and 30 kg/m2 (inclusive) and body weight not less than 50 kg
Key exclusion criteria (1 listed)
- of or current medical illness deemed clinically significant by the Investigator (study physician)
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 |
|---|---|---|
| CanagliflozinType = 1, unit = mg, number = 300, form = tablet, route = oral use. Single tablet taken with or without a meal during 2 treatment periods | Drug | 001 |
Primary outcome
Concentration of canagliflozin in plasma samples
Time frame: For up to 8 days
4 secondary outcomes
Adverse events reported
Time frame: Up to approximately 34 days
Vital signs measurements
Time frame: Up to approximately 34 days
Results from clinical chemistries performed
Time frame: Up to approximately 34 days
Results from 12-lead ECGs performed
Time frame: Up to approximately 34 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 2 Oct 2012.
- Derived from this study: PubMed 27136908Devineni D, Manitpisitkul P, Murphy J, Stieltjes H, Ariyawansa J, Di Prospero NA, Rothenberg P. Effect of food on the pharmacokinetics of canagliflozin, a sodium glucose co-transporter 2 inhibitor, and assessment of dose proportionality in healthy participants. Clin Pharmacol Drug Dev. 2015 Jul;4(4):279-86. doi: 10.1002/cpdd.151. Epub 2014 Dec 11.
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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 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 1 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 2 Oct 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?
Concentration of canagliflozin in plasma samples (time frame: For up to 8 days). 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 NCT01343290, 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 2 Oct 2012.