A Study to Characterize the Pharmacokinetics and Effect of Food on JNJ-31001074 in Healthy Volunteers - Full Text View

Sponsored by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00915434

Purpose

This is an open-label (both the physician and healthy volunteer know which treatment will be administered), single-dose, 4-period study to characterize the pharmacokinetics (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) and effect of food on the pharmacokinetics of JNJ-31001074.

The study consists of three phases: a screening phase to determine eligibility, an open-label 4-period treatment phase and an end-of-study/early withdrawal assessment phase.

Condition	Intervention	Phase
Healthy Pharmacokinetics	Drug: JNJ-31001074	Phase I

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Official Title:	A Single-Dose, Open-Label, Randomized, 4-Way Crossover Study to Characterize the Pharmacokinetics and the Effect of Food of JNJ-31001074 in Healthy Subjects

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

To characterize the pharmacokinetics of JNJ-31001074 after single-dose administration of 1, 3 and 10 mg JNJ-31001074 and to quantify the effect of food on the pharmacokinetics of 10 mg JNJ-31001074. [ Time Frame: Multiple blood and urine samples will be collected for 72 hours after dosing of JNJ-31001074 in each of the 4 treatment periods ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety and tolerability of JNJ-31001074 [ Time Frame: up to 66 days (including 21 day screening period) ] [ Designated as safety issue: Yes ]
To assess pharmacokinetic dose proportionality of JNJ-31001074 after single-dose administration of 1, 3 and 10 mg [ Time Frame: up to 66 days (including 21 day screening period) ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Estimated Study Completion Date:	August 2009

Detailed Description:

This is an open-label (both the physician and healthy volunteer know which treatment will be administered), randomized (treatment order determined by chance), single-dose study to characterize the pharmacokinetics (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) and effect of food on the pharmacokinetics of JNJ-31001074. The study consists of three phases: a screening phase to determine eligibility, an open-label treatment phase and an end-of-study/early withdrawal assessment phase.

During the screening phase, healthy volunteers will be evaluated to see if they meet selection criteria as specified in the protocol. Healthy volunteers who meet these criteria will report to the study center on Day -1 to begin treatment. The open-label treatment phase will consist of 4 periods. In each period, volunteers will receive one of the following treatments: Treatment A 1 mg JNJ-31001074, Treatment B 3 mg JNJ-31001074, Treatment C 10 mg JNJ-31001074, and Treatment D 10 mg JNJ-31001074. Treatment A, B and C will be administered under fasting conditions (no food or beverages for 10 hours prior to dosing) and Treatment D will be administered after a high-fat meal. The order in which volunteers will receive each treatment will be determined in a random fashion (like flipping a coin). Each treatment will be separated by a 7-14 day washout period. Multiple blood and urine samples will be collected for 72 hours after each dose. Safety and tolerability will be assessed throughout the volunteer's participation. Volunteers will be instructed to report any adverse events that occur up to 30 days after their last dose of study drug. The maximum study duration for each volunteer is expected to be 66 days. JNJ-31001074 1, 3 or 10 mg will be administered orally on Day 1 of each of the 4 treatment periods (dose depends on participant's treatment sequence)

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy volunteer between the ages of 18-55
if a woman, must be of non childbearing potential (ie, post menopausal or surgically sterile) and have a negative pregnancy test
body mass index between 18-30
body weight greater than or equal to 50 kilograms
blood pressure between 90 and 140 mgHg systolic and no higher than 90 mgHg diastolic
nonsmoker

Exclusion Criteria:

History of or current clinically significant medical illness
clinically significant abnormal laboratory value(s)
clinically significant abnormal physical examination, vital signs or electrocardiogram
pregnant, lactating or completed last term pregnancy within six months of screening
use of any prescription or non prescription medication except for paracetamol (acetaminophen/TYLENOL)
history of drug or alcohol abuse
history of smoking or use of nicotine-containing substances within the previous two months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00915434

Contacts

Contact: This study is not yet recruiting patients. Please check back for future recruiting sites, or email

info1@veritasmedicine.com

Sponsors and Collaborators

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

Investigators

Study Director:

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

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

More Information

No publications provided

Responsible Party:	Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ( Clinical Leader, Psychiatry )
Study ID Numbers:	CR016180
Study First Received:	June 4, 2009
Last Updated:	August 21, 2009
ClinicalTrials.gov Identifier:	NCT00915434 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Healthy volunteer
Phase I
Non-childbearing potential

JNJ-31001074
Food
Pharmacokinetics

Study placed in the following topic categories:

Oxymetazoline
Phenylephrine
Healthy

ClinicalTrials.gov processed this record on September 03, 2009