Renal InsufficiencyPhase 1NCT01759576

A Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Volunteers With Varying Degrees of Kidney Function

A Phase 1 study testing Canagliflozin (JNJ-28431754) in people with Renal Insufficiency and Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the drug) and pharmacodynamics (ie, how the drug affects the body) of canagliflozin (JNJ-28431754) after administration of a single dose to non-diabetic volunteers with normal kidney function and non-diabetic volunteers with varying… Read more about this study

Who is it for?: Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for: Renal Insufficiency, Healthy
What is being tested?: Canagliflozin (JNJ-28431754)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 3 sitesUnited States
Study dates: Mar 2008to Nov 2008
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 79 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Volunteers must have a body mass index (BMI = weight in kg/height in m2) between 20 and 40 kg/m2 (inclusive), and body weight not less than 50 kg
Volunteers must smoke no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before first study drug administration

Who cannot join

History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
Volunteers with end stage renal disease receiving dialysis treatment other than intermittent hemodialysis
Volunteers with end stage renal disease who have received a renal transplantation within 1 year before screening
Volunteers with end stage renal disease diagnosed with renal carcinoma within 1 year before screening
Volunteers with end stage renal disease receiving immunosuppressive medications, including steroids

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Study site
Knoxville, Tennessee
Study site
Minneapolis, Minnesota
Study site
Orlando, Florida

Other trials in United States

About this study

Official title: An Open-Label, Single-Dose Study to Evaluate JNJ-28431754 Pharmacokinetics, Pharmacodynamics and Safety in Non-Diabetic Subjects With Varying Degrees of Renal Function

Read the detailed description

This study will be an open label (all volunteers and study staff know the identity of the assigned treatment), single-dose, multicenter (the study will be conducted at more than one center), parallel-group study (each group of volunteers will be treated at the same time) to assess the pharmacokinetics and pharmacodynamics of canagliflozin (a drug currently being investigated for the treatment of type 2 diabetes mellitus) in volunteers with varying degrees of kidney function. The study will consist of 3 phases: a screening phase, an open-label treatment phase, and an end-of study (or follow-up) phase. Volunteers will be assigned to 1 of 5 groups (depending on kidney function): group 1 will have normal kidney function; group 2 will have mild kidney impairment; group 3 will have moderate kidney impairment; group 4 will have severe kidney impairment; and group 5 will comprise volunteers requiring hemodialysis. Volunteers in groups 1 through 4 will receive a single dose of canagliflozin on Day 1. Volunteers in group 5 will receive a single dose of canagliflozin following dialysis and then, approximately 10 days later, they will receive a second dose before dialysis. Volunteers in groups 1 through 4 will participate in the study for 27 days. Volunteers in group 5 will participate in the study for 40 days.

Conditions: Renal Insufficiency, Healthy
Being tested: Canagliflozin (JNJ-28431754)
Keywords: Renal Insufficiency, Healthy, Canagliflozin (JNJ-28431754), Pharmacokinetics, Pharmacodynamics, Dialysis
Medical subject headings: Renal Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Canagliflozin (JNJ-28431754)Drug
Also called JNJ-28431754
Volunteers in groups 1 through 4 will receive one 200mg tablet orally (by mouth) on Day 1. Volunteers in group 5 will receive one 200mg tablet orally on Day 1 (one hour after hemodialysis) followed, approximately 10 days later, by one 200mg tablet orally (2 hours before hemodialysis).

Study groups in NCT01759576
Study group	Role	What they receive
Group 1 (normal kidney function)	Experimental	Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1 Receives: Drug: Canagliflozin (JNJ-28431754)
Group 2 (mild kidney impairment)	Experimental	Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1 Receives: Drug: Canagliflozin (JNJ-28431754)
Group 3 (moderate kidney impairment)	Experimental	Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1 Receives: Drug: Canagliflozin (JNJ-28431754)
Group 4 (severe kidney impairment)	Experimental	Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1 Receives: Drug: Canagliflozin (JNJ-28431754)
Group 5 (hemodialysis)	Experimental	Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1 following completion of hemodialysis. Approximately 10 days later, each volunteer will receive another single dose of canagliflozin before hemodialysis begins. Receives: Drug: Canagliflozin (JNJ-28431754)

What is being measured

The primary outcome is the main question the study is designed to answer.

Plasma concentrations of canagliflozin (JNJ-28431754) in varying degrees of kidney function
Plasma concentrations of canagliflozin (JNJ-28431754) following the administration of a single dose of canagliflozin will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug) in varying degrees of kidney function.
Measured: Up to Day 6
Change from baseline in 24-hour urine glucose excretion in varying degrees of kidney function
Change from baseline in 24-hour urine glucose excretion following the administration of a single dose of canagliflozin (JNJ-28431754) will be used to evaluate the pharmacodynamics of canagliflozin (ie, how the drug affects the body) in varying degrees of kidney function.
Measured: Day -1 (Baseline) to Day 3
Plasma concentrations of canagliflozin (JNJ-28431754) metabolites in varying degrees of kidney function
Plasma concentrations of canagliflozin (JNJ-28431754) metabolites following the administration of a single dose of canagliflozin will be used to determine pharmacokinetic parameters for canagliflozin metabolites (measurements describing how the body affects the metabolites) in varying degrees of kidney function.
Measured: Up to Day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2008Nov 2008

First posted3 Jan 2013 (estimated)
Study startMar 2008
Primary completionNov 2008
Study completionNov 2008

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 Renal InsufficiencyStudies 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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01759576
Sponsor's protocol ID: CR014761
Other IDs: 28431754DIA1003
Status last verified: May 2013
First submitted: 24 Dec 2012
Last updated: 29 May 2013
Results posted: No
Data monitoring committee: No

Publications

Devineni D, Curtin CR, Marbury TC, Smith W, Vaccaro N, Wexler D, Vandebosch A, Rusch S, Stieltjes H, Wajs E. Effect of hepatic or renal impairment on the pharmacokinetics of canagliflozin, a sodium glucose co-transporter 2 inhibitor. Clin Ther. 2015 Mar 1;37(3):610-628.e4. doi: 10.1016/j.clinthera.2014.12.013. Epub 2015 Feb 3.
PubMed 25659911

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
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Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
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Recruiting
NightWare and Cardiovascular Health in Women With PTSD
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Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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All Renal Insufficiency trials

Study at a glance

From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Single-Dose Study to Evaluate JNJ-28431754 Pharmacokinetics, Pharmacodynamics and Safety in Non-Diabetic Subjects With Varying Degrees of Renal Function
ClinicalTrials.gov ID: NCT01759576
Acronym / sponsor ID: CR014761
Conditions: Renal Insufficiency, Healthy
Keywords: Renal Insufficiency, Healthy, Canagliflozin (JNJ-28431754), Pharmacokinetics, Pharmacodynamics, Dialysis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Nov 2008 (actual)
Study completion: Nov 2008 (actual)
First posted: 3 Jan 2013 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Group 1 (normal kidney function)	Experimental	Drug: Canagliflozin (JNJ-28431754)Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1
Group 2 (mild kidney impairment)	Experimental	Drug: Canagliflozin (JNJ-28431754)Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1
Group 3 (moderate kidney impairment)	Experimental	Drug: Canagliflozin (JNJ-28431754)Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1
Group 4 (severe kidney impairment)	Experimental	Drug: Canagliflozin (JNJ-28431754)Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1
Group 5 (hemodialysis)	Experimental	Drug: Canagliflozin (JNJ-28431754)Each volunteer will receive a single dose of canagliflozin (JNJ-28431754) on Day 1 following completion of hemodialysis. Approximately 10 days later, each volunteer will receive another single dose of canagliflozin before hemodialysis begins.

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Volunteers must have a body mass index (BMI = weight in kg/height in m2) between 20 and 40 kg/m2 (inclusive), and body weight not less than 50 kg
Volunteers must smoke no more than 10 cigarettes, or 2 cigars, or 2 pipes of tobacco per day for at least 6 months before first study drug administration

Key exclusion criteria (5 listed)

History of or currently active illness considered to be clinically significant by the Investigator or any other illness that the Investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results
Volunteers with end stage renal disease receiving dialysis treatment other than intermittent hemodialysis
Volunteers with end stage renal disease who have received a renal transplantation within 1 year before screening
Volunteers with end stage renal disease diagnosed with renal carcinoma within 1 year before screening
Volunteers with end stage renal disease receiving immunosuppressive medications, including steroids

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 (JNJ-28431754)Also: JNJ-28431754Volunteers in groups 1 through 4 will receive one 200mg tablet orally (by mouth) on Day 1. Volunteers in group 5 will receive one 200mg tablet orally on Day 1 (one hour after hemodialysis) followed, approximately 10 days later, by one 200mg tablet orally (2 hours before hemodialysis).	Drug	Group 1 (normal kidney function), Group 2 (mild kidney impairment), Group 3 (moderate kidney impairment), Group 4 (severe kidney impairment), Group 5 (hemodialysis)

Primary outcome

Plasma concentrations of canagliflozin (JNJ-28431754) in varying degrees of kidney function
Time frame: Up to Day 6
Plasma concentrations of canagliflozin (JNJ-28431754) following the administration of a single dose of canagliflozin will be used to determine pharmacokinetic parameters for canagliflozin (measurements describing how the body affects the drug) in varying degrees of kidney function.
Change from baseline in 24-hour urine glucose excretion in varying degrees of kidney function
Time frame: Day -1 (Baseline) to Day 3
Change from baseline in 24-hour urine glucose excretion following the administration of a single dose of canagliflozin (JNJ-28431754) will be used to evaluate the pharmacodynamics of canagliflozin (ie, how the drug affects the body) in varying degrees of kidney function.
Plasma concentrations of canagliflozin (JNJ-28431754) metabolites in varying degrees of kidney function
Time frame: Up to Day 6
Plasma concentrations of canagliflozin (JNJ-28431754) metabolites following the administration of a single dose of canagliflozin will be used to determine pharmacokinetic parameters for canagliflozin metabolites (measurements describing how the body affects the metabolites) in varying degrees of kidney function.

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 29 May 2013.
Derived from this study: PubMed 25659911Devineni D, Curtin CR, Marbury TC, Smith W, Vaccaro N, Wexler D, Vandebosch A, Rusch S, Stieltjes H, Wajs E. Effect of hepatic or renal impairment on the pharmacokinetics of canagliflozin, a sodium glucose co-transporter 2 inhibitor. Clin Ther. 2015 Mar 1;37(3):610-628.e4. doi: 10.1016/j.clinthera.2014.12.013. Epub 2015 Feb 3.
An Open-Label, Single-Dose Study to Evaluate JNJ-28431754 Pharmacokinetics, Pharmacodynamics and Safety in Non-Diabetic Subjects With Varying Degrees of Renal FunctionLink provided by the sponsor.

Related trials for Renal Insufficiency

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)

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.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 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 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 (JNJ-28431754) in varying degrees of kidney function (time frame: Up to Day 6). The study lists 3 primary outcomes in all. 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 NCT01759576, 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 29 May 2013.