DyslipidemiaPhase 1NCT01879020
Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 After Multiple Doses in Healthy Subjects
A Phase 1 study testing TA-8995 in people with Dyslipidemia, run by Tanabe Pharma Corporation at 1 site in Germany.
Trial summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of TA-8995 after multiple doses in healthy adult male subjects 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
- Dyslipidemia
- What is being tested?
- TA-8995
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2009to Jun 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Free from any clinically significant illness or disease as determined by their medical history, physical examination, laboratory and other tests and as judged by the Investigator.
- Between 18 - 55 years old.
- Male of Caucasian ethnic origin.
- Body mass index (BMI) in the range of 19 - 33 kg/m² and had a minimum weight of 50 kg. Subjects with a BMI in the range 30.0 - 33.0 kg/m² had to have a waist measurement of ≤ 91 cm.
Who cannot join
- High density lipoprotein (HDL)-C level of greater or equal to 2.59 mmol/L (≥ 100 mg/dL) at Screening.
- Abnormal Electrocardiogram (ECG) at Screening or Day -1 including a QTc ≥ 430 ms (The QTc-interval was calculated automatically according to Bazett's formula. In the case of results of ≥ 430 ms, QTc was additionally calculated manually using Fridericia's formula which was used as an exclusion criterion).
- Family history of long QT syndrome, hypokalaemia or Torsades de Pointes
- Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease or history of any psychotic illness
- Presence or history of gastro-intestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Double-blind, Placebo-controlled, Ascending-dose, Phase I Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 After Multiple Doses in Healthy Adult Male Subjects
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of TA-8995 after multiple doses in healthy adult male subjects
- 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
Drug: TA-8995 1mg
TA-8995Drug
Drug: TA-8995 2.5mg
TA-8995Drug
Drug: TA-8995 5mg
TA-8995Drug
Drug: TA-8995 10mg
TA-8995Drug
Drug: TA-8995 25mg
PlaceboDrug
Placebo (TA-8995 1mg)
PlaceboDrug
Placebo (TA-8995 2.5mg)
PlaceboDrug
Placebo (TA-8995 5mg)
PlaceboDrug
Placebo (TA-8995 10mg)
PlaceboDrug
Placebo (TA-8995 25mg)
| Study group | Role | What they receive |
|---|---|---|
| TA-8995 1 mg | Experimental | Not described Receives: Drug: TA-8995 |
| TA-8995 2.5 mg | Experimental | Not described Receives: Drug: TA-8995 |
| TA-8995 5 mg | Experimental | Not described Receives: Drug: TA-8995 |
| TA-8995 10 mg | Experimental | Not described Receives: Drug: TA-8995 |
| TA-8995 25 mg | Experimental | Not described Receives: Drug: TA-8995 |
| Placebo (TA-8995 1mg) | Placebo comparator | Not described Receives: Drug: Placebo |
| Placebo (TA-8995 2.5mg) | Placebo comparator | Not described Receives: Drug: Placebo |
| Placebo (TA-8995 5mg) | Placebo comparator | Not described Receives: Drug: Placebo |
| Placebo (TA-8995 10mg) | Placebo comparator | Not described Receives: Drug: Placebo |
| Placebo (TA-8995 25mg) | 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
Area under the plasma concentration (AUC) versus time curve over the final dosing interval (AUC0-τ, Steady-state)
Measured: 7 days post the final dose
The last time point 't' with a concentration Ct ≥ Lower limit quantification (LLQ) (AUC0-t, Steady-state)
Measured: 7 days post the final dose
Secondary outcomes (2)
Cholesterol ester transfer protein (CETP) activity (%)
Measured: 7 days post the final dose
CETP concentration (mg/mL)
Measured: 4 hours after the first and the fibal 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 startAug 2009
- Primary completionJun 2010
- Study completionJun 2010
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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanabe Pharma Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Werner Weber, MD, Principal investigator, Momentum Pharma Services GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879020
- Sponsor's protocol ID
- TA-8995-E02
- 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, Ascending-dose, Phase I Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 After Multiple Doses in Healthy Adult Male Subjects
- ClinicalTrials.gov ID
- NCT01879020
- Acronym / sponsor ID
- TA-8995-E02
- Conditions
- Dyslipidemia
- Keywords
- MT-8995, Dyslipidemia, Cholesteryl ester transfer proteins
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Tanabe Pharma CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (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, tolerability, pharmacokinetics and pharmacodynamics of TA-8995 after multiple doses in healthy adult male subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| TA-8995 1 mg | Experimental | Drug: TA-8995 |
| TA-8995 2.5 mg | Experimental | Drug: TA-8995 |
| TA-8995 5 mg | Experimental | Drug: TA-8995 |
| TA-8995 10 mg | Experimental | Drug: TA-8995 |
| TA-8995 25 mg | Experimental | Drug: TA-8995 |
| Placebo (TA-8995 1mg) | Placebo comparator | Drug: Placebo |
| Placebo (TA-8995 2.5mg) | Placebo comparator | Drug: Placebo |
| Placebo (TA-8995 5mg) | Placebo comparator | Drug: Placebo |
| Placebo (TA-8995 10mg) | Placebo comparator | Drug: Placebo |
| Placebo (TA-8995 25mg) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Free from any clinically significant illness or disease as determined by their medical history, physical examination, laboratory and other tests and as judged by the Investigator.
- Between 18 - 55 years old.
- Male of Caucasian ethnic origin.
- Body mass index (BMI) in the range of 19 - 33 kg/m² and had a minimum weight of 50 kg. Subjects with a BMI in the range 30.0 - 33.0 kg/m² had to have a waist measurement of ≤ 91 cm.
Key exclusion criteria (5 listed)
- High density lipoprotein (HDL)-C level of greater or equal to 2.59 mmol/L (≥ 100 mg/dL) at Screening.
- Abnormal Electrocardiogram (ECG) at Screening or Day -1 including a QTc ≥ 430 ms (The QTc-interval was calculated automatically according to Bazett's formula. In the case of results of ≥ 430 ms, QTc was additionally calculated manually using Fridericia's formula which was used as an exclusion criterion).
- Family history of long QT syndrome, hypokalaemia or Torsades de Pointes
- Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease or history of any psychotic illness
- Presence or history of gastro-intestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
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-8995Drug: TA-8995 1mg | Drug | TA-8995 1 mg |
| TA-8995Drug: TA-8995 2.5mg | Drug | TA-8995 2.5 mg |
| TA-8995Drug: TA-8995 5mg | Drug | TA-8995 5 mg |
| TA-8995Drug: TA-8995 10mg | Drug | TA-8995 10 mg |
| TA-8995Drug: TA-8995 25mg | Drug | TA-8995 25 mg |
| PlaceboPlacebo (TA-8995 1mg) | Drug | Placebo (TA-8995 1mg) |
| PlaceboPlacebo (TA-8995 2.5mg) | Drug | Placebo (TA-8995 2.5mg) |
| PlaceboPlacebo (TA-8995 5mg) | Drug | Placebo (TA-8995 5mg) |
| PlaceboPlacebo (TA-8995 10mg) | Drug | Placebo (TA-8995 10mg) |
| PlaceboPlacebo (TA-8995 25mg) | Drug | Placebo (TA-8995 25mg) |
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
Area under the plasma concentration (AUC) versus time curve over the final dosing interval (AUC0-τ, Steady-state)
Time frame: 7 days post the final dose
The last time point 't' with a concentration Ct ≥ Lower limit quantification (LLQ) (AUC0-t, Steady-state)
Time frame: 7 days post the final dose
2 secondary outcomes
Cholesterol ester transfer protein (CETP) activity (%)
Time frame: 7 days post the final dose
CETP concentration (mg/mL)
Time frame: 4 hours after the first and the fibal 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.
Werner Weber, MD principal investigator
Momentum Pharma Services GmbH
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 Germany.
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 4 inclusion and 5 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 Germany. 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 5 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.