DyslipidaemiaPhase 1NCT02523391
Bioequivalence Study of Capsule and Tablet Formulations of TA-8995
A Phase 1 study testing TA-8995 in people with Dyslipidaemia, run by Xention Ltd at 1 site in United Kingdom.
Trial summary
The purpose of this study is to compare the pharmacokinetics of capsule and tablet formulations of TA-8995 in healthy male subjects aged 18 to 55 years. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dyslipidaemia
- What is being tested?
- TA-8995
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Nov 2015
- 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males aged 18-55
- Body Mass Index (BMI) between 18.0 and 32.0 kg/m2, inclusive
Who cannot join
- Subject has a known hypersensitivity to any of the inactive ingredients of the study treatments.
- Subject has any other condition which, in the Investigator's opinion will interfere with the study.
- Subjects who are still participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) within 3 months or 5 half-lives (whichever is longer) prior to the first dose in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomised, Open-label Cross-over Bioequivalence Study of Capsule and Tablet Formulations of TA-8995 in Healthy Male Subjects
The purpose of this study is to compare the pharmacokinetics of capsule and tablet formulations of TA-8995 in healthy male subjects aged 18 to 55 years.
- Conditions
- Dyslipidaemia
- Being tested
- TA-8995
- 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
Capsule
TA-8995Drug
Tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment Period 1 | Experimental | Either 5mg TA-8995 Capsule or Tablet Receives: Drug: TA-8995 |
| Treatment Period 2 | Experimental | Either 5mg TA-8995 Capsule or Tablet Receives: Drug: TA-8995 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) of TA-8995 capsule and tablet formulations
Measured: 72 hours
Peak Plasma Concentration (Cmax) of TA-8995 capsule and tablet formulations
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2015
- Study completionNov 2015
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
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xention Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523391
- Sponsor's protocol ID
- TA-8995-08
- Status last verified
- Jan 2016
- First submitted
- 12 Aug 2015
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomised, Open-label Cross-over Bioequivalence Study of Capsule and Tablet Formulations of TA-8995 in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02523391
- Acronym / sponsor ID
- TA-8995-08
- Conditions
- Dyslipidaemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Xention LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 14 Aug 2015 (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 compare the pharmacokinetics of capsule and tablet formulations of TA-8995 in healthy male subjects aged 18 to 55 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Period 1 | Experimental | Drug: TA-8995Either 5mg TA-8995 Capsule or Tablet |
| Treatment Period 2 | Experimental | Drug: TA-8995Either 5mg TA-8995 Capsule or Tablet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males aged 18-55
- Body Mass Index (BMI) between 18.0 and 32.0 kg/m2, inclusive
Key exclusion criteria (3 listed)
- Subject has a known hypersensitivity to any of the inactive ingredients of the study treatments.
- Subject has any other condition which, in the Investigator's opinion will interfere with the study.
- Subjects who are still participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) within 3 months or 5 half-lives (whichever is longer) prior to the first dose in this study.
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-8995Capsule | Drug | Treatment Period 1, Treatment Period 2 |
| TA-8995Tablet | Drug | Treatment Period 1, Treatment Period 2 |
Primary outcome
Area under the plasma concentration versus time curve (AUC) of TA-8995 capsule and tablet formulations
Time frame: 72 hours
Peak Plasma Concentration (Cmax) of TA-8995 capsule and tablet formulations
Time frame: 72 hours
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 29 Jan 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 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 2 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 29 Jan 2016. 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?
Area under the plasma concentration versus time curve (AUC) of TA-8995 capsule and tablet formulations (time frame: 72 hours). The study lists 2 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 29 Jan 2016; AzTrials last refreshed its copy on 8 Nov 2026.