Open-Label, Placebo-Controlled, Parallel Group Study in Healthy Volunteers to Evaluate the Effects of Two Single MT 400 or Naproxen Sodium Tablets

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00596245
• Collaborator: POZEN (Industry)
• Enrollment: 42
• Location: 1
• Arm: 1
• Duration (Months): 2
• Patients Per Site Per Month: 21

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Healthy	Drug: MT400	Phase 1

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• 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
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Dec 1, 2007
• Actual Study Completion Date: Dec 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 MT 400, naproxen sodium 550mg	Drug: MT400; MT 400, naproxen sodium 550mg

Outcome Measures

Primary Outcome Measures

1. 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]

Secondary Outcome Measures

1. Potential subjects will be assessed for exposure to ionizing radiation or working with cytotoxic chemicals. [7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Male or female subjects who are 18-35 years of age at the screening visit

2. Female subjects are eligible for participation in the study if they are of:

3. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or,

4. 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:

• Female sterilization or sterilization of male partner; or,

• Any non-medicated intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year; or,

• Barrier method

1. Physical status within normal limits for age and consistent with observations at Screening

2. 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

3. 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:

1. History of hypersensitivity, allergy, intolerance or contraindication to the use of any triptan, NSAID or aspirin (including all sumatriptan and naproxen preparations) or has nasal polyps and asthma

2. History or presence of cardio-or cerebrovascular disease; e.g., diabetes, hypertension, hyperlipidemia

3. History or presence of congenital heart disease, cardiac arrhythmias requiring medication, or a clinically significant electrocardiogram abnormality that, in the investigator's opinion, contraindicates participation in the study

4. History or evidence of any ischemic vascular diseases including: ischemic heart disease, ischemic abdominal syndromes, peripheral vascular disease or Raynaud's Syndrome, or sign/symptoms consistent with any of the above

5. History or evidence of central nervous system pathology including stroke and/or transient ischemic attacks, epilepsy or structural brain lesions which lower the convulsive threshold, or has been treated with an antiepileptic drug for seizure control within 5 years prior to screening

6. History or evidence of impaired hepatic or renal function or any screening laboratory assessment that is clinically significant in the investigator's opinion

7. Has clinically significant allergic disease (excluding non-active hay fever) or a history of multiple drug allergies

8. Evidence of macrocytic or microcytic anemia or deficiency of folate or B12 at Screening

9. Blood donation in excess of: 500 mL in 14 days; 1,500 mL in 180 days or 2,500 mL in one year

10. History of any bleeding disorder

11. Gastrointestinal disorder, surgery, ulceration, or perforation in the past 6 months; gastrointestinal bleeding in the past year; or evidence or history of inflammatory bowel disease

12. Females actively trying to become pregnant or breast feeding

13. History or evidence of alcohol abuse (more than 28 units of alcohol (male) or 21 units of alcohol (female) per week) or substance abuse within the last year or any concurrent medical or psychiatric condition which, in the investigator's judgment, will likely interfere with the study conduct, subject cooperation, or evaluation and interpretation of the study results, or which otherwise contraindicate participation in this clinical trial

14. Participated in a investigational drug trial within the previous four weeks

15. Used tobacco products within the past year

16. Has taken any medication, including over-the counter, prescription, herbal remedies, within one month of the first dose (with the exception of vitamin/mineral supplements)

17. Is currently working or living in an environment that exposes subject to cytotoxic chemicals or ionizing radiation, or subject has had any medical X-Ray, vaccination, or significant viral or bacterial illness within one month of Screening

18. Body Mass Index outside the range of 19-32 kg/m2 at Screening

19. Presence or history of any malignancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Matthew M. Medlock, MD	Austin	Texas	United States	78744

Sponsors and Collaborators

• GlaxoSmithKline
• POZEN

Investigators

• Principal Investigator: Matthew M Medlock, MD, PPD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00596245
• Other Study ID Numbers: MT400-108
• First Posted: Jan 16, 2008
• Last Update Posted: Apr 16, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by GlaxoSmithKline: non-smoking healthy volunteers aged 18 - 35

Study Results

No Results Posted as of Apr 16, 2015