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Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 With Single, Escalating Doses in Healthy Subjects

Primary Purpose

Dyslipidemia

Status

Completed

Phase

Phase 1

Locations

United Kingdom

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)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)
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

Sites / Locations

Hammersmith Medicines Research (HMR)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Placebo Comparator

Arm Label

Single ascending dose in Caucasian men

Age-effect in Caucasian men

Gender-effect in Caucasian women

Single ascending dose in Japanese men

Placebo: Single ascending dose in Caucasian men

Placebo: Age-effect in Caucasian men

Placeo: Gender-effect in Caucasian women

Placebo: Single ascending dose in Japanese men

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)

Peak concentration (ng/mL) of TA-8995

Time of peak concentration (hr) of TA-8995

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

Secondary Outcome Measures

Plasma Cholesterol Ester Transfer Protein (CETP) activity (%) and concentration (mg/mL)

Full Information

NCT ID

NCT01878474

First Posted

June 4, 2013

Last Updated

June 12, 2013

Sponsor

Mitsubishi Tanabe Pharma Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01878474

Brief Title

Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 With Single, Escalating Doses in Healthy Subjects

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2013

Overall Recruitment Status

Completed

Study Start Date

March 2008 (undefined)

Primary Completion Date

June 2009 (Actual)

Study Completion Date

June 2009 (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 and tolerability of single doses of TA-8995 in healthy Caucasian and Japanese volunteers.

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

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single ascending dose in Caucasian men

Arm Type

Experimental

Arm Title

Age-effect in Caucasian men

Arm Type

Experimental

Arm Title

Gender-effect in Caucasian women

Arm Type

Experimental

Arm Title

Single ascending dose in Japanese men

Arm Type

Experimental

Arm Title

Placebo: Single ascending dose in Caucasian men

Arm Type

Placebo Comparator

Arm Title

Placebo: Age-effect in Caucasian men

Arm Type

Placebo Comparator

Arm Title

Placeo: Gender-effect in Caucasian women

Arm Type

Placebo Comparator

Arm Title

Placebo: Single ascending dose in Japanese men

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

TA-8995

Intervention Description

TA-8905 5, 10, 25, 50 (fasted and fed), 100 and 150 mg

Intervention Type

Drug

Intervention Name(s)

TA-8995

Intervention Description

Drug: TA-8995 25 mg

Intervention Type

Drug

Intervention Name(s)

TA-8995

Intervention Description

Drug: TA-8995 25 mg

Intervention Type

Drug

Intervention Name(s)

TA-8995

Intervention Description

Drug: TA-8995 25, 50, 100 and 150 mg

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Single ascending dose in Caucasian men

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Age-effect in Caucasian men

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Gender-effect in Caucasian women

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Single ascending dose in Japanese men

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

Peak concentration (ng/mL) of TA-8995

Time Frame

336 hours post dose

Title

Time of peak concentration (hr) of TA-8995

Time Frame

336 hours post dose

Title

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

Secondary Outcome Measure Information:

Title

Plasma Cholesterol Ester Transfer Protein (CETP) activity (%) and concentration (mg/mL)

Time Frame

336 hours post dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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) 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steve Warrington, MA MD FRCP FFPM

Organizational Affiliation

Hammersmith Medicines Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hammersmith Medicines Research (HMR)

City

London

ZIP/Postal Code

NW10 7EW

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 With Single, Escalating Doses in Healthy Subjects

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