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

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 1

Conditions: Dyslipidemia

Treatments: Drug: TA-8995; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01879020

TA-8995-E02

Details and patient eligibility

About

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

Enrollment: 61 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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61 participants in 10 patient groups, including a placebo group

TA-8995 1 mg

Experimental group

Treatment:

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

TA-8995 2.5 mg

Experimental group

Treatment:

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

TA-8995 5 mg

Experimental group

Treatment:

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

TA-8995 10 mg

Experimental group

Treatment:

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

TA-8995 25 mg

Experimental group

Treatment:

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

Placebo (TA-8995 1mg)

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Placebo (TA-8995 2.5mg)

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Placebo (TA-8995 5mg)

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Placebo (TA-8995 10mg)

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Placebo (TA-8995 25mg)

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo