Alzheimer's DiseasePhase 1NCT01253499
Multiple Dose Study of TRx0037
A Phase 1 study testing TRx0037 in people with Alzheimer's Disease, run by TauRx Therapeutics Ltd.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TRx0037 after multiple doses in elderly volunteers. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- TRx0037
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to May 2010
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female 55 and over
- No clinically important abnormal physical finding
- No clinically significant lab results
- Normal ECG
- Normal BP and HR
- BMI between 19 and 32
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- Weight 50 to 100 kg
- Able to communicate
- Provide written informed consent
- Non smokers
- Males to use contraception
- Females to be surgically sterile or post menopausal
Who cannot join
- Administration of any IMP other than study drug within 12 weeks before entry
- Use of any prescribed meds, St John's wort, over the counter meds as described in the protocol
- Surgical or medical condition that might interfere with IMP
- History of drug or alcohol abuse
- Clinically significant allergy requiring treatment
- Loss of greater than 400ml of blood within 12 weeks.
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- Serious adverse reaction or hypersensitivity to any drug
- Presence of Hep B, Hep c or HIV-1 or HIV-2 at screening
- Presence of G6PD at screening
- History of methaemoglobinaemia
- Partner who is pregnant of lactating
- Positive Pregnancy test
About this study
Official title: A Phase 1 Study Consisting of a Double-Blind, Placebo Controlled Multiple Dose Study of TRx0037 in Healthy Elderly Volunteers
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TRx0037 after multiple doses in elderly volunteers.
- Conditions
- Alzheimer's Disease
- Being tested
- TRx0037
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRx0037Drug
75mg and 100mg tablets used to create doses of 100mg and 175mg. Active placebo 2mg and blank placebo used as comparators.
| Study group | Role | What they receive |
|---|---|---|
| TRx0037 | Experimental | Double blind placebo controlled study of TRx0037 in healthy elderly volunteers to assess safety, tolerability, bioavailability and pharmacokinetics Receives: Drug: TRx0037 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability
The bioavailability of TRx0037 in an older population closer to the typical age range of the target patient population.
Measured: 19 Days (7-10 day follow up)
Pharmacokinetics
The pharmacokinetics for single doses of TRx0037 in healthy elderly volunteers.
Measured: 19 Days (7-10 day follow up)
Safety and tolerability
Safety and tolerability measurements including adverse events, physical examination findings, vital signs, ECG, and clinical laboratory measurements for single doses of TRx0037
Measured: 19 Days (7-10 day follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- TauRx Therapeutics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Investigators
- Stuart Dr Mair, MBChB, Principal investigator, Quotient Clinical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01253499
- Sponsor's protocol ID
- TRx-037-003
- Status last verified
- Dec 2010
- First submitted
- 2 Dec 2010
- Last updated
- 17 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Consisting of a Double-Blind, Placebo Controlled Multiple Dose Study of TRx0037 in Healthy Elderly Volunteers
- ClinicalTrials.gov ID
- NCT01253499
- Acronym / sponsor ID
- TRx-037-003
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- TauRx Therapeutics LtdIndustry (pharma, biotech, devices)
- Collaborators
- Quotient Clinical
- Study start
- Mar 2010
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 3 Dec 2010 (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.
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of TRx0037 after multiple doses in elderly volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRx0037 | Experimental | Drug: TRx0037Double blind placebo controlled study of TRx0037 in healthy elderly volunteers to assess safety, tolerability, bioavailability and pharmacokinetics |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male and female 55 and over
- No clinically important abnormal physical finding
- No clinically significant lab results
- Normal ECG
- Normal BP and HR
Key exclusion criteria (12 listed)
- Administration of any IMP other than study drug within 12 weeks before entry
- Use of any prescribed meds, St John's wort, over the counter meds as described in the protocol
- Surgical or medical condition that might interfere with IMP
- History of drug or alcohol abuse
- Clinically significant allergy requiring treatment
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 |
|---|---|---|
| TRx003775mg and 100mg tablets used to create doses of 100mg and 175mg. Active placebo 2mg and blank placebo used as comparators. | Drug | TRx0037 |
Primary outcome
Bioavailability
Time frame: 19 Days (7-10 day follow up)
The bioavailability of TRx0037 in an older population closer to the typical age range of the target patient population.
Pharmacokinetics
Time frame: 19 Days (7-10 day follow up)
The pharmacokinetics for single doses of TRx0037 in healthy elderly volunteers.
Safety and tolerability
Time frame: 19 Days (7-10 day follow up)
Safety and tolerability measurements including adverse events, physical examination findings, vital signs, ECG, and clinical laboratory measurements for single doses of TRx0037
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 17 Dec 2010.
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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.
Stuart Dr Mair, MBChB principal investigator
Quotient Clinical
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TRx0037 in people with Alzheimer's Disease, run by TauRx Therapeutics Ltd.
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 12 inclusion and 12 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 17 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
Bioavailability (time frame: 19 Days (7-10 day follow up)). The study lists 3 primary outcomes in all. 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 17 Dec 2010.