Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 After Multiple Doses in Healthy Subjects

June 12, 2013 updated by: Mitsubishi Tanabe Pharma Corporation

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
61

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 22769
        • Momentum Pharma Services GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TA-8995 1 mg
Drug: TA-8995
Drug: TA-8995 1mg
Drug: TA-8995
Drug: TA-8995 2.5mg
Drug: TA-8995
Drug: TA-8995 5mg
Drug: TA-8995
Drug: TA-8995 10mg
Drug: TA-8995
Drug: TA-8995 25mg
Experimental: TA-8995 2.5 mg
Drug: TA-8995
Drug: TA-8995 1mg
Drug: TA-8995
Drug: TA-8995 2.5mg
Drug: TA-8995
Drug: TA-8995 5mg
Drug: TA-8995
Drug: TA-8995 10mg
Drug: TA-8995
Drug: TA-8995 25mg
Experimental: TA-8995 5 mg
Drug: TA-8995
Drug: TA-8995 1mg
Drug: TA-8995
Drug: TA-8995 2.5mg
Drug: TA-8995
Drug: TA-8995 5mg
Drug: TA-8995
Drug: TA-8995 10mg
Drug: TA-8995
Drug: TA-8995 25mg
Experimental: TA-8995 10 mg
Drug: TA-8995
Drug: TA-8995 1mg
Drug: TA-8995
Drug: TA-8995 2.5mg
Drug: TA-8995
Drug: TA-8995 5mg
Drug: TA-8995
Drug: TA-8995 10mg
Drug: TA-8995
Drug: TA-8995 25mg
Experimental: TA-8995 25 mg
Drug: TA-8995
Drug: TA-8995 1mg
Drug: TA-8995
Drug: TA-8995 2.5mg
Drug: TA-8995
Drug: TA-8995 5mg
Drug: TA-8995
Drug: TA-8995 10mg
Drug: TA-8995
Drug: TA-8995 25mg
Placebo Comparator: Placebo (TA-8995 1mg)
Drug: Placebo
Placebo (TA-8995 1mg)
Drug: Placebo
Placebo (TA-8995 2.5mg)
Drug: Placebo
Placebo (TA-8995 5mg)
Drug: Placebo
Placebo (TA-8995 10mg)
Drug: Placebo
Placebo (TA-8995 25mg)
Placebo Comparator: Placebo (TA-8995 2.5mg)
Drug: Placebo
Placebo (TA-8995 1mg)
Drug: Placebo
Placebo (TA-8995 2.5mg)
Drug: Placebo
Placebo (TA-8995 5mg)
Drug: Placebo
Placebo (TA-8995 10mg)
Drug: Placebo
Placebo (TA-8995 25mg)
Placebo Comparator: Placebo (TA-8995 5mg)
Drug: Placebo
Placebo (TA-8995 1mg)
Drug: Placebo
Placebo (TA-8995 2.5mg)
Drug: Placebo
Placebo (TA-8995 5mg)
Drug: Placebo
Placebo (TA-8995 10mg)
Drug: Placebo
Placebo (TA-8995 25mg)
Placebo Comparator: Placebo (TA-8995 10mg)
Drug: Placebo
Placebo (TA-8995 1mg)
Drug: Placebo
Placebo (TA-8995 2.5mg)
Drug: Placebo
Placebo (TA-8995 5mg)
Drug: Placebo
Placebo (TA-8995 10mg)
Drug: Placebo
Placebo (TA-8995 25mg)
Placebo Comparator: Placebo (TA-8995 25mg)
Drug: Placebo
Placebo (TA-8995 1mg)
Drug: Placebo
Placebo (TA-8995 2.5mg)
Drug: Placebo
Placebo (TA-8995 5mg)
Drug: Placebo
Placebo (TA-8995 10mg)
Drug: Placebo
Placebo (TA-8995 25mg)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of participants with adverse events
Time Frame: 336 hours post dose
336 hours post dose
Laboratory tests (haematology, biochemistry and urinalysis)
Time Frame: 336 hours post dose
336 hours post dose
Vital signs (supine systolic and diastolic blood pressure, heart rate and body temperature)
Time Frame: 336 hours post dose
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
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
7 days post the final dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Cholesterol ester transfer protein (CETP) activity (%)
Time Frame: 7 days post the final dose
7 days post the final dose
CETP concentration (mg/mL)
Time Frame: 4 hours after the first and the fibal dose
4 hours after the first and the fibal dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mitsubishi Tanabe Pharma Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Werner Weber, MD, Momentum Pharma Services GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 4, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TA-8995-E02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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