A Single and Multiple Dose Study to Explore the Safety Of JNJ-40346527 In Healthy Volunteers

NCT01054014 | Completed Phase 1

• 1 other identifier: CR016795
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the safety, tolerability and pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and it is removed from the body over time) of single and multiple doses of JNJ-40346527 in healthy volunteers. This study will also investigate the pharmacokinetics of JNJ-40346527 with and without food.

Conditions

Health

Keywords

CR016795

Outcome Measures

Primary Outcomes (1)

• To assess the safety, tolerability and pharmacokinetics (PK) of JNJ-40346427 after administration of single and multiple oral ascending doses of JNJ-40346427 in healthy volunteers and the PK of JNJ-4034627 with and without food.

  from time of dosing to follow-up (28-35 days)

Secondary Outcomes (1)

• To assess the pharmacodynamics (explores what the drug does to the body) of JNJ-40346527.

  Part 1: Days 1 & 2; Part 2: Days 1, 7, 14, and 15

Study Arms (3)

001

EXPERIMENTAL

JNJ-40346527/Placebo Single oral dose of JNJ-40346527 (either 10 50 150 300 600 or 1000mg) or Placebo

Drug: JNJ-40346527/Placebo

002

EXPERIMENTAL

JNJ-40346527/Placebo JNJ-40346527 once daily oral dose for 14 days (either 50 150 300 500 or 750mg) or Placebo

Drug: JNJ-40346527/Placebo

003

EXPERIMENTAL

JNJ-40346527 JNJ-40346527 150mg one dose either fasting (or with food) then after 7 days off treatment JNJ-40346527 150mg either with food (or fasting)

Drug: JNJ-40346527

Interventions

JNJ-40346527/Placebo DRUG

Single oral dose of JNJ-40346527 (either 10, 50, 150, 300, 600, or 1000mg) or Placebo

001

JNJ-40346527 DRUG

JNJ-40346527 150mg one dose, either fasting (or with food), then after 7 days off treatment, JNJ-40346527 150mg either with food (or fasting)

003

Eligibility Criteria

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

You may qualify if:

• Must be generally in good health
• Have negative result for HIV,hepatitis B, and hepatitis C
• Non-smoker for at least 6 months
• Females must be of non childbearing potential,i.e., either: surgically sterile (bilateral tubal ligation or removal of ovaries and/or uterus or partial hysterectomy at least 6 months prior to dosing), or naturally postmenopausal for at least 2 years, with negative blood and urine pregnancy tests prior to dosing
• must consent to use a medically acceptable method of contraception throughout the entire study period and for 90 days after the study is completed

You may not qualify if:

• History of alcohol or drug abuse
• Average consumption of more than 5 cups of caffeinated beverages (tea/coffee/cocoa/cola) per day
• History of any type of significant allergies (eg, anaphylaxis, prominent respiratory and skin symptoms)
• Use of St.John's Wort (hypericin) for 30 days before first dosing
• Use of any type of hormone replacement therapy for 30 days before the first dose
• history of receiving a live virus vaccination within the past month or plans to receive vaccination with a live virus vaccine within 2 weeks following the last dose of medication
• receipt of an experimental drug or medical device within the last month

Sponsors & Collaborators

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

Study Sites (1)

Unknown Facility

Antwerp, Belgium

Location

MeSH Terms

Interventions

JNJ-40346527

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2010
• First Posted: January 22, 2010
• Study Start: January 1, 2010
• Study Completion: January 1, 2011
• Last Updated: September 4, 2013

Record last verified: 2013-09

Locations

BE (1)