A Study to Characterize the Pharmacokinetics and Effect of Food on JNJ-31001074 in Healthy Volunteers
NCT00915434 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2010-04-26
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
Interventions
- DRUG
-
JNJ-31001074
Sponsors & Collaborators
-
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
lead INDUSTRY
Principal Investigators
-
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Allocation
- RANDOMIZED
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2009-06-30
- Completion
- 2009-11-30
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