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

NCT ID: NCT01879020

Last Updated: 2013-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-06-30

Brief Summary

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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

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Detailed Description

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Conditions

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Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TA-8995 1 mg

Group Type EXPERIMENTAL

TA-8995

Intervention Type DRUG

Drug: TA-8995 1mg

TA-8995 2.5 mg

Group Type EXPERIMENTAL

TA-8995

Intervention Type DRUG

Drug: TA-8995 2.5mg

TA-8995 5 mg

Group Type EXPERIMENTAL

TA-8995

Intervention Type DRUG

Drug: TA-8995 5mg

TA-8995 10 mg

Group Type EXPERIMENTAL

TA-8995

Intervention Type DRUG

Drug: TA-8995 10mg

TA-8995 25 mg

Group Type EXPERIMENTAL

TA-8995

Intervention Type DRUG

Drug: TA-8995 25mg

Placebo (TA-8995 1mg)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (TA-8995 1mg)

Placebo (TA-8995 2.5mg)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (TA-8995 2.5mg)

Placebo (TA-8995 5mg)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (TA-8995 5mg)

Placebo (TA-8995 10mg)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (TA-8995 10mg)

Placebo (TA-8995 25mg)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo (TA-8995 25mg)

Interventions

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TA-8995

Drug: TA-8995 1mg

Intervention Type DRUG

TA-8995

Drug: TA-8995 2.5mg

Intervention Type DRUG

TA-8995

Drug: TA-8995 5mg

Intervention Type DRUG

TA-8995

Drug: TA-8995 10mg

Intervention Type DRUG

TA-8995

Drug: TA-8995 25mg

Intervention Type DRUG

Placebo

Placebo (TA-8995 1mg)

Intervention Type DRUG

Placebo

Placebo (TA-8995 2.5mg)

Intervention Type DRUG

Placebo

Placebo (TA-8995 5mg)

Intervention Type DRUG

Placebo

Placebo (TA-8995 10mg)

Intervention Type DRUG

Placebo

Placebo (TA-8995 25mg)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Werner Weber, MD

Role: PRINCIPAL_INVESTIGATOR

Momentum Pharma Services GmbH

Locations

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Momentum Pharma Services GmbH

Hamburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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TA-8995-E02

Identifier Type: -

Identifier Source: org_study_id

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