DyslipidemiaPhase 1NCT01878474
Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 With Single, Escalating Doses in Healthy Subjects
A Phase 1 study testing TA-8995 in people with Dyslipidemia, run by Tanabe Pharma Corporation at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the safety and tolerability of single doses of TA-8995 in healthy Caucasian and Japanese volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- TA-8995
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2008to Jun 2009
- 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
- Caucasian men aged 18-55 years and ≥65 years
- Women of non-childbearing potential
- Japanese men aged 18-55 years
- Subjects were deemed healthy on the basis of medical history, physical examination, Electrocardiogram (ECG), vital signs and safety tests of blood and urine
- Subjects were able to give fully informed written consent
Who cannot join
- HDL-C level ≥2.59 mmol/L
- Abnormal Holter ECG
- Family history of long QT syndrome, hypokalaemia or Torsade de Pointes
- Vital signs or 12-lead ECG values outside the acceptable range
- Positive tests for hepatitis B and C, HIV 1 and 2
- Positive urine pregnancy test (women only)
Show all 15Show fewer
- Severe adverse reaction or allergy to any drug
- Drug or alcohol abuse
- Smoking within the 6 months before dosing with TA-8995 (Caucasian subjects), or smoking more than 10 cigarettes daily (Japanese subjects)
- Over-the-counter or prescribed medication up to 7 days or 5 half-lives (whichever was longer) before dosing with TA-8995
- Consuming food or drinks containing grapefruit or cranberry within the 7 days before dosing
- Participation in other clinical trials, or loss of more than 450 mL blood within the previous 3 months
- Clinically relevant abnormal findings at the screening assessment
- Clinically relevant abnormal medical history or concurrent medical condition
- Possibility that volunteer would not cooperate
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hammersmith Medicines Research (HMR)
London, NW10 7EW
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, First Time-in-humans Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single, Escalating Doses of TA-8995 in Healthy Subjects
The purpose of this study is to assess the safety and tolerability of single doses of TA-8995 in healthy Caucasian and Japanese volunteers.
- Conditions
- Dyslipidemia
- Being tested
- TA-8995, Placebo
- Keywords
- MT-8995, Dyslipidemia, Cholesteryl ester transfer proteins
- 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
TA-8905 5, 10, 25, 50 (fasted and fed), 100 and 150 mg
TA-8995Drug
Drug: TA-8995 25 mg
TA-8995Drug
Drug: TA-8995 25 mg
TA-8995Drug
Drug: TA-8995 25, 50, 100 and 150 mg
PlaceboDrug
Single ascending dose in Caucasian men
PlaceboDrug
Age-effect in Caucasian men
PlaceboDrug
Gender-effect in Caucasian women
PlaceboDrug
Single ascending dose in Japanese men
| Study group | Role | What they receive |
|---|---|---|
| Single ascending dose in Caucasian men | Experimental | Not described Receives: Drug: TA-8995 |
| Age-effect in Caucasian men | Experimental | Not described Receives: Drug: TA-8995 |
| Gender-effect in Caucasian women | Experimental | Not described Receives: Drug: TA-8995 |
| Single ascending dose in Japanese men | Experimental | Not described Receives: Drug: TA-8995 |
| Placebo: Single ascending dose in Caucasian men | Placebo comparator | Not described Receives: Drug: Placebo |
| Placebo: Age-effect in Caucasian men | Placebo comparator | Not described Receives: Drug: Placebo |
| Placeo: Gender-effect in Caucasian women | Placebo comparator | Not described Receives: Drug: Placebo |
| Placebo: Single ascending dose in Japanese men | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: 336 hours post dose
Laboratory tests (haematology, biochemistry and urinalysis)
Measured: 336 hours post dose
Vital signs (supine systolic and diastolic blood pressure, heart rate and body temperature)
Measured: 336 hours post dose
Peak concentration (ng/mL) of TA-8995
Measured: 336 hours post dose
Time of peak concentration (hr) of TA-8995
Measured: 336 hours post dose
Area under the concentration-time curve (mg/L・hr) up to 24 h (AUC0-24), 72 h (AUC0-72), 168 h (AUC0-168), 336 h (AUC0-336) and infinity (AUC0-∞) of TA-8995
Measured: 336 hours post dose
Secondary outcomes (1)
Plasma Cholesterol Ester Transfer Protein (CETP) activity (%) and concentration (mg/mL)
Measured: 336 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2013 (estimated)
- Study startMar 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steve Warrington, MA MD FRCP FFPM, Principal investigator, Hammersmith Medicines Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01878474
- Sponsor's protocol ID
- TA-8995-01
- Status last verified
- Jun 2013
- First submitted
- 4 Jun 2013
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, First Time-in-humans Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single, Escalating Doses of TA-8995 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01878474
- Acronym / sponsor ID
- TA-8995-01
- Conditions
- Dyslipidemia
- Keywords
- MT-8995, Dyslipidemia, Cholesteryl ester transfer proteins
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 17 Jun 2013 (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 assess the safety and tolerability of single doses of TA-8995 in healthy Caucasian and Japanese volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Single ascending dose in Caucasian men | Experimental | Drug: TA-8995 |
| Age-effect in Caucasian men | Experimental | Drug: TA-8995 |
| Gender-effect in Caucasian women | Experimental | Drug: TA-8995 |
| Single ascending dose in Japanese men | Experimental | Drug: TA-8995 |
| Placebo: Single ascending dose in Caucasian men | Placebo comparator | Drug: Placebo |
| Placebo: Age-effect in Caucasian men | Placebo comparator | Drug: Placebo |
| Placeo: Gender-effect in Caucasian women | Placebo comparator | Drug: Placebo |
| Placebo: Single ascending dose in Japanese men | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Caucasian men aged 18-55 years and ≥65 years
- Women of non-childbearing potential
- Japanese men aged 18-55 years
- Subjects were deemed healthy on the basis of medical history, physical examination, Electrocardiogram (ECG), vital signs and safety tests of blood and urine
- Subjects were able to give fully informed written consent
Key exclusion criteria (15 listed)
- HDL-C level ≥2.59 mmol/L
- Abnormal Holter ECG
- Family history of long QT syndrome, hypokalaemia or Torsade de Pointes
- Vital signs or 12-lead ECG values outside the acceptable range
- Positive tests for hepatitis B and C, HIV 1 and 2
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-8995TA-8905 5, 10, 25, 50 (fasted and fed), 100 and 150 mg | Drug | Single ascending dose in Caucasian men |
| TA-8995Drug: TA-8995 25 mg | Drug | Age-effect in Caucasian men |
| TA-8995Drug: TA-8995 25 mg | Drug | Gender-effect in Caucasian women |
| TA-8995Drug: TA-8995 25, 50, 100 and 150 mg | Drug | Single ascending dose in Japanese men |
| PlaceboSingle ascending dose in Caucasian men | Drug | Placebo: Single ascending dose in Caucasian men |
| PlaceboAge-effect in Caucasian men | Drug | Placebo: Age-effect in Caucasian men |
| PlaceboGender-effect in Caucasian women | Drug | Placeo: Gender-effect in Caucasian women |
| PlaceboSingle ascending dose in Japanese men | Drug | Placebo: Single ascending dose in Japanese men |
Primary outcome
Number of participants with adverse events
Time frame: 336 hours post dose
Laboratory tests (haematology, biochemistry and urinalysis)
Time frame: 336 hours post dose
Vital signs (supine systolic and diastolic blood pressure, heart rate and body temperature)
Time frame: 336 hours post dose
Peak concentration (ng/mL) of TA-8995
Time frame: 336 hours post dose
Time of peak concentration (hr) of TA-8995
Time frame: 336 hours post dose
Area under the concentration-time curve (mg/L・hr) up to 24 h (AUC0-24), 72 h (AUC0-72), 168 h (AUC0-168), 336 h (AUC0-336) and infinity (AUC0-∞) of TA-8995
Time frame: 336 hours post dose
1 secondary outcome
Plasma Cholesterol Ester Transfer Protein (CETP) activity (%) and concentration (mg/mL)
Time frame: 336 hours post dose
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 Jun 2013.
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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.
Steve Warrington, MA MD FRCP FFPM principal investigator
Hammersmith Medicines Research
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 Dyslipidemia, run by Tanabe Pharma Corporation 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 5 inclusion and 15 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 Jun 2013. 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?
Number of participants with adverse events (time frame: 336 hours post dose). The study lists 6 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 Jun 2013.