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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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