HealthyPhase 1NCT00596245
Open-Label, Placebo-Controlled, Parallel Group Study in Healthy Volunteers to Evaluate the Effects of Two Single MT 400 or Naproxen Sodium Tablets
A Phase 1 study testing MT400 in people with Healthy, run by GlaxoSmithKline at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MT400
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Dec 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
- 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,
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- Barrier method
- 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
Who cannot join
- 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
- History or presence of cardio-or cerebrovascular disease; e.g., diabetes, hypertension, hyperlipidemia
- 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
- 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
- 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
- History or evidence of impaired hepatic or renal function or any screening laboratory assessment that is clinically significant in the investigator's opinion
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- Has clinically significant allergic disease (excluding non-active hay fever) or a history of multiple drug allergies
- Evidence of macrocytic or microcytic anemia or deficiency of folate or B12 at Screening
- Blood donation in excess of: 500 mL in 14 days; 1,500 mL in 180 days or 2,500 mL in one year
- History of any bleeding disorder
- 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
- Females actively trying to become pregnant or breast feeding
- 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
- Participated in a investigational drug trial within the previous four weeks
- Used tobacco products within the past year
- 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)
- 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
- Body Mass Index outside the range of 19-32 kg/m2 at Screening
- Presence or history of any malignancy
Trial locations and contacts
1 site in 1 country.
About this 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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- MT400
- Keywords
- non-smoking healthy volunteers aged 18 - 35
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT400Drug
MT 400, naproxen sodium 550mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MT 400, naproxen sodium 550mg Receives: Drug: MT400 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
Secondary outcomes (1)
Potential subjects will be assessed for exposure to ionizing radiation or working with cytotoxic chemicals.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- POZEN
- Responsible party
- Sponsor
- Investigators
- Matthew M Medlock, MD, Principal investigator, PPD Development, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596245
- Sponsor's protocol ID
- MT400-108
- Status last verified
- Apr 2015
- First submitted
- 4 Jan 2008
- Last updated
- 16 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00596245
- Acronym / sponsor ID
- MT400-108
- Conditions
- Healthy
- Keywords
- non-smoking healthy volunteers aged 18 - 35
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Collaborators
- POZEN
- Study start
- Oct 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MT400MT 400, naproxen sodium 550mg |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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:
- 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
Key exclusion criteria (19 listed)
- 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
- History or presence of cardio-or cerebrovascular disease; e.g., diabetes, hypertension, hyperlipidemia
- 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
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT400MT 400, naproxen sodium 550mg | Drug | 1 |
Primary outcome
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.
Time frame: 7 days
1 secondary outcome
Potential subjects will be assessed for exposure to ionizing radiation or working with cytotoxic chemicals.
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew M Medlock, MD principal investigator
PPD Development, LP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MT400 in people with Healthy, run by GlaxoSmithKline at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2015.