AdultPhase 1NCT00960180
Study Evaluating Single Ascending Doses of MR1817
A Phase 1 study testing MR1817 in people with Adult, run by Mochida Pharmaceutical Company, Ltd. at 1 site in United Kingdom.
Trial summary
This is a first-in-human study of MR1817. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MR1817 after administration of ascending single oral doses to healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Adult
- What is being tested?
- MR1817
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2010to Jan 2011
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Inclusion criteria: 1- Men or women of non-childbearing potential (WONCBP) aged 18 to 55 years inclusive at screening.
2- Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight ≥50 kg. 3- Healthy as determined by the investigator on the basis of screening evaluations.
Exclusion criteria: 1- Presence or history of any disorder that may prevent the successful completion of the study. 2- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. 3- History of drug abuse within 1 year before study day 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Single Doses of Orally Administered MR1817 in Healthy Adult Subjects
This is a first-in-human study of MR1817. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MR1817 after administration of ascending single oral doses to healthy adult subjects.
- Conditions
- Adult
- Being tested
- MR1817, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR1817Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: MR1817 |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety based on adverse event reporting, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests
Measured: 6 weeks
Secondary outcomes (1)
MR1817 plasma and urine concentration.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2009 (estimated)
- Study startJul 2010
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdultStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mochida Pharmaceutical Company, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Miller, Study director, Fulcrum Pharma (Europe) Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960180
- Sponsor's protocol ID
- 3260A1-1000
- Status last verified
- May 2011
- First submitted
- 14 Aug 2009
- Last updated
- 13 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Single Doses of Orally Administered MR1817 in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT00960180
- Acronym / sponsor ID
- 3260A1-1000
- Conditions
- Adult
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Mochida Pharmaceutical Company, Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 17 Aug 2009 (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 a first-in-human study of MR1817. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MR1817 after administration of ascending single oral doses to healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MR1817 |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| MR1817 | Drug | 1 |
| Placebo | Drug | 2 |
Primary outcome
Safety based on adverse event reporting, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests
Time frame: 6 weeks
1 secondary outcome
MR1817 plasma and urine concentration.
Time frame: 6 weeks
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 13 Jan 2014.
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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.
Robert Miller study director
Fulcrum Pharma (Europe) Ltd
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 MR1817 in people with Adult, run by Mochida Pharmaceutical Company, Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 13 Jan 2014. 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 Kingdom. 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. Some participants in this study may receive a placebo. 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?
Safety based on adverse event reporting, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests (time frame: 6 weeks). 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 13 Jan 2014.