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| Name | Class |
|---|---|
| POZEN | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | MT 400, naproxen sodium 550mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT400 | Drug | MT 400, naproxen sodium 550mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective is to assess the impact on production of chromosomal aberration after dosage of MT 400 or naproxen sodium versus placebo. Comparison of post-dose chromosomal aberration rates will also be made to baseline rates within each arm. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Potential subjects will be assessed for exposure to ionizing radiation or working with cytotoxic chemicals. | 7 days |
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Inclusion Criteria:
Male or female subjects who are 18-35 years of age at the screening visit
Female subjects are eligible for participation in the study if they are of:
Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,
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:
Physical status within normal limits for age and consistent with observations at Screening
Subject agrees to remain sequestered on site during the treatment phase of the study and is willing and able to abstain from the consumption or use of any alcohol, caffeine containing beverages or medication for the duration of the study
Subject is able to understand and comply with study procedures required and able and willing to provide written informed consent prior to any study procedures being performed
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew M Medlock, MD | PPD Development, LP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Matthew M. Medlock, MD | Austin | Texas | 78744 | United States |
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