DyslipidaemiaPhase 1NCT02241759
Study of the Electrocardiographic Effects of TA-8995
A Phase 1 study testing TA-8995 and Moxifloxacin in people with Dyslipidaemia, run by Xention Ltd at 1 site in United Kingdom.
Trial summary
A study in healthy males and females to see if a high single dose of TA-8995 has an effect on the ECG QTcF interval. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidaemia
- What is being tested?
- TA-8995 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2014to Dec 2014
- 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
Who may be able to join
- Healthy male or females of non-child bearing potential
Who cannot join
- Receiving any other drug therapy
- Clinically significant medical history
- Abnormal ECGs or vital signs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Single-Centre, Randomised, Placebo and Positive- Controlled, Parallel-Group Study of the Electrocardiographic Effects of TA-8995 in Healthy Male and Female Subjects
A study in healthy males and females to see if a high single dose of TA-8995 has an effect on the ECG QTcF interval.
- Conditions
- Dyslipidaemia
- Being tested
- TA-8995, Moxifloxacin, Placebo
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TA-8995Drug
MoxifloxacinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| TA-8995 | Experimental | Single oral dose of 150mg TA-8995 Receives: Drug: TA-8995 |
| Placebo | Experimental | Single oral dose of placebo to TA-8995 Receives: Drug: Placebo |
| Moxifloxacin | Active comparator | Single open-label oral dose of 400mg moxifloxacin Receives: Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in QT interval corrected for heart rate (QTc) for TA-8995 versus placebo
Measured: 4 days
Secondary outcomes (1)
Relationship between plasma levels of TA-8995 and the QTcF effect
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidaemiaStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xention Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ashley Brooks, Principal investigator, Covance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02241759
- Sponsor's protocol ID
- TA-8995-04
- Status last verified
- Feb 2015
- First submitted
- 20 Aug 2014
- Last updated
- 16 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Single-Centre, Randomised, Placebo and Positive- Controlled, Parallel-Group Study of the Electrocardiographic Effects of TA-8995 in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT02241759
- Acronym / sponsor ID
- TA-8995-04
- Conditions
- Dyslipidaemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Xention LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 16 Sep 2014 (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.
A study in healthy males and females to see if a high single dose of TA-8995 has an effect on the ECG QTcF interval.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TA-8995 | Experimental | Drug: TA-8995Single oral dose of 150mg TA-8995 |
| Placebo | Experimental | Drug: PlaceboSingle oral dose of placebo to TA-8995 |
| Moxifloxacin | Active comparator | Drug: MoxifloxacinSingle open-label oral dose of 400mg moxifloxacin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male or females of non-child bearing potential
Key exclusion criteria (3 listed)
- Receiving any other drug therapy
- Clinically significant medical history
- Abnormal ECGs or vital signs
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 |
|---|---|---|
| TA-8995 | Drug | TA-8995 |
| Moxifloxacin | Drug | Moxifloxacin |
| Placebo | Drug | Placebo |
Primary outcome
Change from baseline in QT interval corrected for heart rate (QTc) for TA-8995 versus placebo
Time frame: 4 days
1 secondary outcome
Relationship between plasma levels of TA-8995 and the QTcF effect
Time frame: 4 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 Feb 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.
Ashley Brooks principal investigator
Covance
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 TA-8995 and Moxifloxacin in people with Dyslipidaemia, run by Xention 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?
The sponsor lists 1 inclusion and 3 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 Feb 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 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. 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?
Change from baseline in QT interval corrected for heart rate (QTc) for TA-8995 versus placebo (time frame: 4 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 Feb 2015.