A Study to Assess Electrocardiogram Results in Healthy Volunteers Receiving Canagliflozin (JNJ-28431754)

NCT01787357 | Completed Phase 1

• 2 other identifiers: CR01551428431754DIA1010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effect of canagliflozin (JNJ-28431754) on electrocardiogram results (recordings of the electrical activity of the heart) in healthy volunteers after a single therapeutic dose (300 mg) and a single supra-therapeutic dose (4 times higher \[1,200 mg\] than the anticipated therapeutic dose of 300 mg). The safety and tolerability of canagliflozin will also be assessed.

Conditions

Healthy

Keywords

Healthy; Canagliflozin (JNJ-28431754); Pharmacokinetics; Moxifloxacin; Electrocardiogram Parameters; QT/QTc Interval; Therapeutic dose; Supra-Therapeutic dose

Outcome Measures

Primary Outcomes (1)

• Change from baseline in QTc intervals

  QT intervals (assessment of the electrical activity of the heart) will be measured from 12-lead electrocardiogram (ECG) readings and will be corrected for heart rate. The corrected QT intervals (QTc) obtained following single doses of 300 mg canagliflozin (JNJ-28431754), 1,200 mg canagliflozin, and 400 mg moxifloxacin, will be compared with QTc intervals obtained following dosing with placebo.

  Day 1 (Predose) up to Day 2

Secondary Outcomes (4)

• Number of volunteers with adverse events

  Up to 61 days

• Plasma concentrations of canagliflozin (JNJ-28431754)

  Up to Day 2

• QRS intervals obtained from 12-lead electrocardiogram (ECG) readings

  Up to Day 2

• PR intervals obtained from 12-lead electrocardiogram (ECG) readings

  Up to Day 2

Study Arms (4)

Sequence 1 (ADBC)

EXPERIMENTAL

Each volunteer will receive Treatment A on Day 1 of Treatment Period 1, followed by Treatment D on Day 1 of Treatment Period 2, followed by Teatment B on Day 1 of Treatment Period 3, and followed by Treatment C on Day 1 of Treatment Period 4. Each treatment period will be 2 days in duration and there will be a washout period (with no medication) of 10 to 14 days between each treatment period.

Drug: Canagliflozin (JNJ-28431754); Drug: Placebo; Drug: Moxifloxacin

Sequence 2 (BACD)

EXPERIMENTAL

Each volunteer will receive Treatment B on Day 1 of Treatment Period 1, followed by Treatment A on Day 1 of Treatment Period 2, followed by Treatment C on Day 1 of Treatment Period 3, and followed by Treatment D on Day 1 of Treatment Period 4. Each treatment period will be 2 days in duration and there will be a washout period (with no medication) of 10 to 14 days between each treatment period.

Drug: Canagliflozin (JNJ-28431754); Drug: Placebo; Drug: Moxifloxacin

Sequence 3 (CBDA)

EXPERIMENTAL

Each volunteer will receive Treatment C on Day 1 of Treatment Period 1, followed by Treatment B on Day 1 of Treatment Period 2, followed by Treatment D on Day 1 of Treatment Period 3, and followed by Treatment A on Day 1 of Treatment Period 4. Each treatment period will be 2 days in duration and there will be a washout period (with no medication) of 10 to 14 days between each treatment period.

Drug: Canagliflozin (JNJ-28431754); Drug: Placebo; Drug: Moxifloxacin

Sequence 4 (DCAB)

EXPERIMENTAL

Each volunteer will receive Treatment D on Day 1 of Treatment Period 1, followed by Treatment C on Day 1 of Treatment Period 2, followed by Treatment A on Day 1 of Treatment Period 3, and followed by Treatment B on Day 1 of Treatment Period 4. Each treatment period will be 2 days in duration and there will be a washout period (with no medication) of 10 to 14 days between each treatment period.

Drug: Canagliflozin (JNJ-28431754); Drug: Placebo; Drug: Moxifloxacin

Interventions

Canagliflozin (JNJ-28431754) DRUG

One 300 mg dose of canagliflozin (JNJ-28431754) (comprising one 100 mg over-encapsulated tablet and one 200 mg over-encapsulated tablet) taken orally (by mouth) on Day 1 of Treatment A. One 1,200 mg dose of canagliflozin (comprising six 200 mg over-encapsulated tablets) taken orally on Day 1 of Treatment B.

Also known as: JNJ-28431754

Sequence 1 (ADBC); Sequence 2 (BACD); Sequence 3 (CBDA); Sequence 4 (DCAB)

Placebo DRUG

Four over-encapsulated matching placebo tablets taken orally (by mouth) on Day 1 of Treatment A. Six over-encapsulated matching placebo tablets taken orally on Day 1 of Treatment C. Five encapsulated matching placebo tablets taken orally on Day 1 of Treatment D.

Sequence 1 (ADBC); Sequence 2 (BACD); Sequence 3 (CBDA); Sequence 4 (DCAB)

Moxifloxacin DRUG

One 400 mg over-encapsulated tablet of moxifloxacin taken orally (by mouth) on Day 1 of Treatment D.

Sequence 1 (ADBC); Sequence 2 (BACD); Sequence 3 (CBDA); Sequence 4 (DCAB)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteers must have a body mass index (BMI = weight in kg/height in m2) between 18 and 35 kg/m2 (inclusive) and body weight not less than 50 kg
• Volunteers must have an average of triplicate 12-lead electrocardiogram (ECG) recordings, taken with a maximum of 2 minutes between recordings, consistent with normal cardiac conduction and function, as specified by the protocol
• Volunteers must be non-smokers

You may not qualify if:

• 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
• History of additional risk factors for the presence of a family history of Short QT Syndrome, Long QT Syndrome, sudden unexplained death at a young age (\<=40 years), drowning or sudden infant death syndrome in a first degree relative (ie, biological parent, sibling, or child)

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Study Sites (1)

Unknown Facility

Tempe, Arizona, United States

Location

Related Links

• A Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled, Four-Way Crossover Study Evaluating Electrocardiogram Intervals in Healthy Adults Receiving a Single, Oral Dose of JNJ-28431754 at Therapeutic and Supra-Therapeutic Doses

MeSH Terms

Interventions

Canagliflozin; Moxifloxacin

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

  Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2013
• First Posted: February 8, 2013
• Study Start: June 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: June 29, 2016

Record last verified: 2016-06

Locations

US (1)