HealthyPhase 1NCT01173549
A Study of 28431754 (Canagliflozin) on Gastrointestinal Glucose Absorption and Metabolism in Healthy Volunteers
A Phase 1 study of 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 evaluate the effect of canagliflozin on gastrointestinal glucose absorption in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Sep 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Have a Body Mass Index (BMI) between 20 and 27 kg/m2 (inclusive) and a body weight not less than 50 kg
- Be healthy on the basis of physical examination including medical history, vital signs, 12-lead ECG, and all other screening lab tests performed at Screening and Admission
- Agree (if men) to use a double barrier method of birth control (e.g., condom for them and use of spermacide with diaphragm, hormonal contraceptives or intrauterine devices by female partner) during the study and for three months following the last dose of study medication, and to not donate sperm during the study and for 3 months after receiving the last dose of study medication
- Willing/able to adhere to the prohibitions and restrictions specified in this protocol
- Must have signed an informed consent form.
Who cannot join
- Have a history of, or currently active, illness or medical condition or disorder that the Investigator considers to be clinically significant
- Has been a smoker or tobacco user within the past 6 months
- Have a history of recent major surgery (within 6 months of study start)
- Tested positive for serology: hepatitis B surface antigen (HBsAg), hepatitis C antibodies (anti-HCV) or human immunodeficiency virus (HIV) antibodies
- Fasting plasma glucose > 110 mg/dL
- Have a history of alcohol or drug abuse within 2 years prior to Screening or a positive test for alcohol and/or drugs of abuse (including but not limited to barbiturates, opiates, cocaine, cannabinoids, amphetamines,MDMA (Ecstasy) and benzodiazepines) at Screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Placebo Controlled, 2-Period Crossover Study to Evaluate the Effect of a Single Dose of JNJ-28431754 (Canagliflozin) on Gastrointestinal Glucose Absorption and Metabolism in Healthy Subjects
The purpose of this study is to evaluate the effect of canagliflozin on gastrointestinal glucose absorption in healthy volunteers.
Read the detailed description
This is a single center study that will be conducted in two Parts (Part 1 and Part 2) to evaluate the effect of a single-dose of canagliflozin on the absorption of glucose in healthy volunteers. Part 1 is a pilot (small) study where responses to key pharmocodynamic (PD) parameters (ie, specific tests on blood samples to evaluate effects of no treatment on the body) will be measured to confirm the study design and number of volunteers planned for Part 2. Part 2 is the main study where volunteers will be randomized (assigned to study drug or placebo by chance) to receive double-blind (neither the volunteer or study physician will know the identity of the treatment assigned) treatment with canagliflozin or placebo (treatment identical in appearance to canagliflozin but contains no active drug) to evaluate the effect of canagliflozin compared to placebo on gastrointestinal glucose absorption using a radiolabeled glucose tracer approach (ie, where a radioactive substance is combined with glucose allowing the movement of glucose in the body to be traced or detected). Blood and urine samples will be collected from volunteers at pre-defined times during the study for PD analysis. Safety will be monitored during the study by evaluating adverse events and results from clinical laboratory tests, vital signs measurements, electrocardiograms (ECGs), and physical examinations performed. Volunteers in Part 1 will receive 240 ml of water 10 minutes before starting of the MMTT in each period (Periods 1 and 2). Volunteers in Part 2 will receive study drug 20 minutes prior to starting of the MMTT in treatment sequence 1 (a single 300-mg dose of canagliflozin in Period 1 followed by matching placebo in Period 2) or in treatment Sequence 2 (matching placebo in Period 1 followed by a single 300-mg dose of canagliflozin in Period 2). Periods 1 and 2 will be separated by 7 to 21 days.
- Conditions
- Healthy
- Being tested
- Canagliflozin/Placebo Placebo/Canagliflozin, no intervention
- Keywords
- Canagliflozin, Pharmacodynamic, Glucose absorption, Glucose metabolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canagliflozin/Placebo Placebo/CanagliflozinDrug
Part 2: 240 mL water 20 min prior to the MMTT on Day 1 of Periods 1 and 2 in each treatment sequence (1 dose of canagliflozin in Period 1 followed by 1 dose of placebo in Period 2 and then crossover to 1 dose of placebo in Period 1 followed by 1 dose of canagliflozin in Period 2).
no interventionOther
Part 1: 240 mL water 10 minutes (min) prior to the start of the MMTT on Day 1 of Periods 1 and 2. Periods 1 and 2 will be separated by 7 to 21 days.
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | no intervention Part 1: 240 mL water 10 minutes (min) prior to the start of the MMTT on Day 1 of Periods 1 and 2. Periods 1 and 2 will be separated by 7 to 21 days. Receives: Other: no intervention |
| 002 | Experimental | Canagliflozin/Placebo Placebo/Canagliflozin Part 2: 240 mL water 20 min prior to the MMTT on Day 1 of Periods 1 and 2 in each treatment sequence (1 dose of canagliflozin in Period 1 followed by 1 dose of placebo in Period 2 and then crossover to 1 dose of placebo in Period 1 followed by 1 dose of canagliflozin in Period 2). Receives: Drug: Canagliflozin/Placebo Placebo/Canagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of ingested glucose that is absorbed in systemic circulation
Measured: During the first 1 and 2 hours after a standard mixed meal
Secondary outcomes (5)
The amount of ingested glucose that is absorbed in systemic circulation
Measured: 2-6 hr and 0-6 hr after a standard mixed meal
Endogenous glucose production (EGP)
Measured: At protocol-specified time points after a standard mixed meal
Total and incremental plasma glucose and insulin area under the curve (AUC)
Measured: 0-1, 0-2, 2-6, and 0-6 hours after a standard mixed meal
Gastric emptying: peak level, time to peak level, and AUCs
Measured: 0-6 hours after a standard mixed meal
Rate of Peripheral glucose disposal (Rd)
Measured: At protocol-specified time points after a standard mixed meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2010 (estimated)
- Study startNov 2010
- Study completionSep 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 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 & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01173549
- Sponsor's protocol ID
- CR017224
- Other IDs
- 28431754DIA1022
- Status last verified
- Dec 2011
- First submitted
- 29 Jul 2010
- Last updated
- 2 Jan 2012
- Results posted
- No
Publications
Polidori D, Sha S, Mudaliar S, Ciaraldi TP, Ghosh A, Vaccaro N, Farrell K, Rothenberg P, Henry RR. Canagliflozin lowers postprandial glucose and insulin by delaying intestinal glucose absorption in addition to increasing urinary glucose excretion: results of a randomized, placebo-controlled study. Diabetes Care. 2013 Aug;36(8):2154-61. doi: 10.2337/dc12-2391. Epub 2013 Feb 14.
PubMed 23412078
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo Controlled, 2-Period Crossover Study to Evaluate the Effect of a Single Dose of JNJ-28431754 (Canagliflozin) on Gastrointestinal Glucose Absorption and Metabolism in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01173549
- Acronym / sponsor ID
- CR017224
- Conditions
- Healthy
- Keywords
- Canagliflozin, Pharmacodynamic, Glucose absorption, Glucose metabolism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Nov 2010
- Study completion
- Sep 2011 (actual)
- First posted
- 2 Aug 2010 (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 canagliflozin on gastrointestinal glucose absorption in healthy volunteers.
Detailed description
This is a single center study that will be conducted in two Parts (Part 1 and Part 2) to evaluate the effect of a single-dose of canagliflozin on the absorption of glucose in healthy volunteers. Part 1 is a pilot (small) study where responses to key pharmocodynamic (PD) parameters (ie, specific tests on blood samples to evaluate effects of no treatment on the body) will be measured to confirm the study design and number of volunteers planned for Part 2. Part 2 is the main study where volunteers will be randomized (assigned to study drug or placebo by chance) to receive double-blind (neither the volunteer or study physician will know the identity of the treatment assigned) treatment with canagliflozin or placebo (treatment identical in appearance to canagliflozin but contains no active drug) to evaluate the effect of canagliflozin compared to placebo on gastrointestinal glucose absorption using a radiolabeled glucose tracer approach (ie, where a radioactive substance is combined with glucose allowing the movement of glucose in the body to be traced or detected). Blood and urine samples will be collected from volunteers at pre-defined times during the study for PD analysis. Safety will be monitored during the study by evaluating adverse events and results from clinical laboratory tests, vital signs measurements, electrocardiograms (ECGs), and physical examinations performed. Volunteers in Part 1 will receive 240 ml of water 10 minutes before starting of the MMTT in each period (Periods 1 and 2). Volunteers in Part 2 will receive study drug 20 minutes prior to starting of the MMTT in treatment sequence 1 (a single 300-mg dose of canagliflozin in Period 1 followed by matching placebo in Period 2) or in treatment Sequence 2 (matching placebo in Period 1 followed by a single 300-mg dose of canagliflozin in Period 2). Periods 1 and 2 will be separated by 7 to 21 days.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Other: no interventionno intervention Part 1: 240 mL water 10 minutes (min) prior to the start of the MMTT on Day 1 of Periods 1 and 2. Periods 1 and 2 will be separated by 7 to 21 days. |
| 002 | Experimental | Drug: Canagliflozin/Placebo Placebo/CanagliflozinCanagliflozin/Placebo Placebo/Canagliflozin Part 2: 240 mL water 20 min prior to the MMTT on Day 1 of Periods 1 and 2 in each treatment sequence (1 dose of canagliflozin in Period 1 followed by 1 dose of placebo in Period 2 and then crossover to 1 dose of placebo in Period 1 followed by 1 dose of canagliflozin in Period 2). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Have a Body Mass Index (BMI) between 20 and 27 kg/m2 (inclusive) and a body weight not less than 50 kg
- Be healthy on the basis of physical examination including medical history, vital signs, 12-lead ECG, and all other screening lab tests performed at Screening and Admission
- Agree (if men) to use a double barrier method of birth control (e.g., condom for them and use of spermacide with diaphragm, hormonal contraceptives or intrauterine devices by female partner) during the study and for three months following the last dose of study medication, and to not donate sperm during the study and for 3 months after receiving the last dose of study medication
- Willing/able to adhere to the prohibitions and restrictions specified in this protocol
- Must have signed an informed consent form.
Key exclusion criteria (6 listed)
- Have a history of, or currently active, illness or medical condition or disorder that the Investigator considers to be clinically significant
- Has been a smoker or tobacco user within the past 6 months
- Have a history of recent major surgery (within 6 months of study start)
- Tested positive for serology: hepatitis B surface antigen (HBsAg), hepatitis C antibodies (anti-HCV) or human immunodeficiency virus (HIV) antibodies
- Fasting plasma glucose > 110 mg/dL
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/Placebo Placebo/CanagliflozinPart 2: 240 mL water 20 min prior to the MMTT on Day 1 of Periods 1 and 2 in each treatment sequence (1 dose of canagliflozin in Period 1 followed by 1 dose of placebo in Period 2 and then crossover to 1 dose of placebo in Period 1 followed by 1 dose of canagliflozin in Period 2). | Drug | 002 |
| no interventionPart 1: 240 mL water 10 minutes (min) prior to the start of the MMTT on Day 1 of Periods 1 and 2. Periods 1 and 2 will be separated by 7 to 21 days. | Other | 001 |
Primary outcome
The amount of ingested glucose that is absorbed in systemic circulation
Time frame: During the first 1 and 2 hours after a standard mixed meal
5 secondary outcomes
The amount of ingested glucose that is absorbed in systemic circulation
Time frame: 2-6 hr and 0-6 hr after a standard mixed meal
Endogenous glucose production (EGP)
Time frame: At protocol-specified time points after a standard mixed meal
Total and incremental plasma glucose and insulin area under the curve (AUC)
Time frame: 0-1, 0-2, 2-6, and 0-6 hours after a standard mixed meal
Gastric emptying: peak level, time to peak level, and AUCs
Time frame: 0-6 hours after a standard mixed meal
Rate of Peripheral glucose disposal (Rd)
Time frame: At protocol-specified time points after a standard mixed meal
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 Jan 2012.
- Derived from this study: PubMed 23412078Polidori D, Sha S, Mudaliar S, Ciaraldi TP, Ghosh A, Vaccaro N, Farrell K, Rothenberg P, Henry RR. Canagliflozin lowers postprandial glucose and insulin by delaying intestinal glucose absorption in addition to increasing urinary glucose excretion: results of a randomized, placebo-controlled study. Diabetes Care. 2013 Aug;36(8):2154-61. doi: 10.2337/dc12-2391. Epub 2013 Feb 14.
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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.
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 of 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?
The sponsor lists 5 inclusion and 6 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 Jan 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?
The amount of ingested glucose that is absorbed in systemic circulation (time frame: During the first 1 and 2 hours after a standard mixed meal). 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 NCT01173549, 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 Jan 2012.