Status:
COMPLETED
Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 With Single, Escalating Doses in Healthy Subjects
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Dyslipidemia
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01878474
Start Date
March 1 2008
End Date
June 1 2009
Last Update
June 17 2013
Active Locations (1)
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1
Hammersmith Medicines Research (HMR)
London, United Kingdom, NW10 7EW