Back to results

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

Primary Purpose

Dyslipidemia

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

TA-8995

Placebo

About this trial

This is an interventional treatment trial for Dyslipidemia focused on measuring MT-8995, Dyslipidemia, Cholesteryl ester transfer proteins

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Momentum Pharma Services GmbH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Placebo Comparator

Arm Label

TA-8995 1 mg

TA-8995 2.5 mg

TA-8995 5 mg

TA-8995 10 mg

TA-8995 25 mg

Placebo (TA-8995 1mg)

Placebo (TA-8995 2.5mg)

Placebo (TA-8995 5mg)

Placebo (TA-8995 10mg)

Placebo (TA-8995 25mg)

Arm Description

Outcomes

Primary Outcome Measures

Number of participants with adverse events

Laboratory tests (haematology, biochemistry and urinalysis)

Vital signs (supine systolic and diastolic blood pressure, heart rate and body temperature)

Area under the plasma concentration (AUC) versus time curve over the final dosing interval (AUC0-τ, Steady-state)

The last time point 't' with a concentration Ct ≥ Lower limit quantification (LLQ) (AUC0-t, Steady-state)

Secondary Outcome Measures

Cholesterol ester transfer protein (CETP) activity (%)

CETP concentration (mg/mL)

Full Information

NCT ID

NCT01879020

First Posted

June 4, 2013

Last Updated

June 12, 2013

Sponsor

Mitsubishi Tanabe Pharma Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01879020

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

August 2009 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyslipidemia

Keywords

MT-8995, Dyslipidemia, Cholesteryl ester transfer proteins

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TA-8995 1 mg

Arm Type

Experimental

Arm Title

TA-8995 2.5 mg

Arm Type

Experimental

Arm Title

TA-8995 5 mg

Arm Type

Experimental

Arm Title

TA-8995 10 mg

Arm Type

Experimental

Arm Title

TA-8995 25 mg

Arm Type

Experimental

Arm Title

Placebo (TA-8995 1mg)

Arm Type

Placebo Comparator

Arm Title

Placebo (TA-8995 2.5mg)

Arm Type

Placebo Comparator

Arm Title

Placebo (TA-8995 5mg)

Arm Type

Placebo Comparator

Arm Title

Placebo (TA-8995 10mg)

Arm Type

Placebo Comparator

Arm Title

Placebo (TA-8995 25mg)

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

TA-8995

Intervention Description

Drug: TA-8995 1mg

Intervention Type

Drug

Intervention Name(s)

TA-8995

Intervention Description

Drug: TA-8995 2.5mg

Intervention Type

Drug

Intervention Name(s)

TA-8995

Intervention Description

Drug: TA-8995 5mg

Intervention Type

Drug

Intervention Name(s)

TA-8995

Intervention Description

Drug: TA-8995 10mg

Intervention Type

Drug

Intervention Name(s)

TA-8995

Intervention Description

Drug: TA-8995 25mg

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo (TA-8995 1mg)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo (TA-8995 2.5mg)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo (TA-8995 5mg)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo (TA-8995 10mg)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo (TA-8995 25mg)

Primary Outcome Measure Information:

Title

Number of participants with adverse events

Time Frame

336 hours post dose

Title

Laboratory tests (haematology, biochemistry and urinalysis)

Time Frame

336 hours post dose

Title

Vital signs (supine systolic and diastolic blood pressure, heart rate and body temperature)

Time Frame

336 hours post dose

Title

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

Title

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

Secondary Outcome Measure Information:

Title

Cholesterol ester transfer protein (CETP) activity (%)

Time Frame

7 days post the final dose

Title

CETP concentration (mg/mL)

Time Frame

4 hours after the first and the fibal dose

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Werner Weber, MD

Organizational Affiliation

Momentum Pharma Services GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Momentum Pharma Services GmbH

City

Hamburg

ZIP/Postal Code

22769

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs