Last updated: 11/04/2018 09:20:08
Open-Label, Placebo-Controlled, Parallel Group Study in Healthy Volunteers to Evaluate the Effects of Two Single MT 400 or Naproxen Sodium Tablets
GSK study ID
MT400-108
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial 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.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
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.
Timeframe: 7 days
Secondary outcomes:
Potential subjects will be assessed for exposure to ionizing radiation or working with cytotoxic chemicals.
Timeframe: 7 days
Interventions:
Drug: MT400
Enrollment:
42
Observational study model:
Not applicable
Primary completion date:
2007-31-12
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Healthy
Product
sumatriptan/naproxen
Collaborators
Pozen
Study date(s)
October 2007 to December 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 35 Years
Accepts healthy volunteers
Yes
- 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:
- 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
Inclusion and exclusion criteria
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: a. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant); or, b. 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 3. Physical status within normal limits for age and consistent with observations at Screening 4. 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 5. 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
Trial location(s)
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Completed
Actual primary completion date
2007-31-12
Actual study completion date
2007-31-12
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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