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

NCT00915434 | Completed Phase 1

• 1 other identifier: CR016180
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy; Pharmacokinetics

Keywords

Healthy volunteer; Phase I; Non-childbearing potential; JNJ-31001074; Food; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• 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.

  Multiple blood and urine samples will be collected for 72 hours after dosing of JNJ-31001074 in each of the 4 treatment periods

Secondary Outcomes (2)

• To evaluate the safety and tolerability of JNJ-31001074

  up to 66 days (including 21 day screening period)

• To assess pharmacokinetic dose proportionality of JNJ-31001074 after single-dose administration of 1, 3 and 10 mg

  up to 66 days (including 21 day screening period)

Interventions

JNJ-31001074 DRUG

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Interventions

bavisant

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: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 4, 2009
• First Posted: June 8, 2009
• Study Start: June 1, 2009
• Study Completion: November 1, 2009
• Last Updated: April 26, 2010

Record last verified: 2010-04