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| Sponsor: | POZEN |
|---|---|
| Collaborator: |
GlaxoSmithKline |
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00596245 |
Purpose
This is an open-label, parallel group, single-center study. The study design consists of a screening and a treatment period. A total of 42 (approximately 21 of each sex) non-smoking healthy volunteers aged 18 - 35.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: MT400 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Basic Science, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics Study |
| Official Title: | Open-Label, Placebo-Controlled, Parallel Group Study in Healthy Volunteers to Evaluate the Effects of Two Single MT 400 or Naproxen Sodium Tablets Administered Two Hours Apart on Chromosomal Aberrations in Peripheral Blood Lymphocytes |
| Estimated Enrollment: | 42 |
| Study Start Date: | October 2007 |
| Study Completion Date: | December 2007 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
MT 400, naproxen sodium 550mg
|
Drug: MT400
MT 400, naproxen sodium 550mg
|
This is an open-label, parallel group, single-center study. The study design consists of a screening and a treatment period. A total of 42 (approximately 21 of each sex) non-smoking healthy volunteers aged 18 - 35, will be selected for treatment. Potential subjects will be assessed for exposure to ionizing radiation or working with cytotoxic chemicals, or who have cell cycle times that fall outside the range of 13 ± 1.5 hours or subjects with stable chromosomal rearrangements and/or abnormally high background chromosomal aberration frequencies. Approximately 30 subjects (10 per arm) are estimated to be needed for analysis.
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Female subjects are eligible for participation in the study if they are of:
Childbearing potential, have a negative pregnancy test (urine) at Screening, and at least one of the following applies or is agreed to by the subject:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Pozen ( David Taylor ) |
| Study ID Numbers: | MT400-108 |
| Study First Received: | January 4, 2008 |
| Last Updated: | September 2, 2008 |
| ClinicalTrials.gov Identifier: | NCT00596245 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
non-smoking healthy volunteers aged 18 - 35 |
|
Anti-Inflammatory Agents Naproxen Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Gout Suppressants Pharmacologic Actions |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |