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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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