A First-in-Human Study of JNJ-28431754 in Healthy Male Volunteers

NCT01177150 | Completed Phase 1

• 2 other identifiers: CR01245428431754NAP1001
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and or the pharmacodynamics (PD) of single oral doses of JNJ-28431754 in healthy male volunteers. The study will evaluate the PK and PD effects of study drug in volunteers who fasted compared to those who did not fast before study drug administration.

Conditions

Healthy

Keywords

Sodium-Glucose Transporter 2; Canagliflozin; Pharmacodynamic; Pharmacokinetic; Safety; Tolerability

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability assessed by evaluating adverse events reported and results from vital signs measurements, electrocardiograms, physical examinations performed and laboratory tests.

  From Screening (within 21 days prior to Day 1) up to Day 14 or at the time of early withdrawal

Secondary Outcomes (3)

• Urine Glucose Excretion (the amount of glucose excreted in the urine per 24 hours and the amount of glucose excreted in each urine collection fraction)

  At protocol-specified timepoints before and after study drug administration on Day 1

• The renal threshold for Urinary Glucose Excretion

  At protocol-specified timepoints before and after study drug administration on Day 1

• Plasma glucose, serum insulin and serum C peptide concentrations measured from blood samples collected

  At protocol-specified timepoints before and after study drug administration on Day 1

Study Arms (2)

001

EXPERIMENTAL

JNJ-28431754/ Placebo Part 1: One oral dose of JNJ 28431754 (10 mg to 600 mg) or matching placebo will be administered after an overnight fast of at least 10 hours .For patients who receive a previously tested dose as 2 equally divided doses the evening dose will be administered at 10 hours after the morning dose.

Drug: JNJ-28431754/ Placebo

002

EXPERIMENTAL

JNJ-28431754 Part 2: A single dose of JNJ-28431754 will be orally administered on 2 occasions (14 days apart) after an overnight fast of at least 10 hours with and without a standard meal.

Drug: JNJ-28431754

Interventions

JNJ-28431754/ Placebo DRUG

Part 1: One oral dose of JNJ 28431754 (10 mg to 600 mg) or matching placebo will be administered after an overnight fast of at least 10 hours .For patients who receive a previously tested dose as 2 equally divided doses, the evening dose will be administered at 10 hours after the morning dose.

001

JNJ-28431754 DRUG

Part 2: A single dose of JNJ-28431754 will be orally administered on 2 occasions (14 days apart) after an overnight fast of at least 10 hours with and without a standard meal.

002

Eligibility Criteria

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

You may qualify if:

• Have body mass index (BMI) between 20.0 and 29.9 kg/m2 inclusive
• Be a non-smoker or non-tobacco user (not smoked cigarettes or used tobacco-containing products for at least 6 months prior to screening)
• Have competency in speaking and comprehending the language where the study will be conducted

You may not qualify if:

• Have history, or family history of bleeding or coagulation disorders or history of disorders that are potential causes of occult (test positive for fecal blood test without visible blood in feces) gastrointestinal bleeding
• Have currently active skin disorders
• Have history of renal or urinary tract diseases
• Have history of having chronically taken (daily administration for more than 7 days) oral steroids, topical iodine, aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), anticoagulants or other drugs known to interfere with blood clotting within 3 months of study start, or anticipates a need to take any of these during the course of the study
• Have history of recent major surgery (within 6 months of study start)
• Have history of recent travel (within 6 months) to locations that may predispose to the acquisition of communicable illnesses (e.g., parasitic or water-borne illnesses in developing tropical regions)
• Have recent history of alcohol or drug abuse within 6 months prior to screening

Sponsors & Collaborators

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

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: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 6, 2010
• Study Start: November 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: August 11, 2010

Record last verified: 2010-08