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

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

The purpose of this study is to assess the safety and tolerability of single doses of TA-8995 in healthy Caucasian and Japanese 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