Recruitment

Recruitment Status
Completed

Inclusion Criterias

Women of non-childbearing potential
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
...
Women of non-childbearing potential
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
Caucasian men aged 18-55 years and ≥65 years
Japanese men aged 18-55 years

Exclusion Criterias

Consuming food or drinks containing grapefruit or cranberry within the 7 days before dosing
Clinically relevant abnormal findings at the screening assessment
Participation in other clinical trials, or loss of more than 450 mL blood within the previous 3 months
...
Consuming food or drinks containing grapefruit or cranberry within the 7 days before dosing
Clinically relevant abnormal findings at the screening assessment
Participation in other clinical trials, or loss of more than 450 mL blood within the previous 3 months
Positive tests for hepatitis B and C, HIV 1 and 2
Severe adverse reaction or allergy to any drug
Positive urine pregnancy test (women only)
Possibility that volunteer would not cooperate
Smoking within the 6 months before dosing with TA-8995 (Caucasian subjects), or smoking more than 10 cigarettes daily (Japanese subjects)
HDL-C level ≥2.59 mmol/L
Clinically relevant abnormal medical history or concurrent medical condition
Over-the-counter or prescribed medication up to 7 days or 5 half-lives (whichever was longer) before dosing with TA-8995
Family history of long QT syndrome, hypokalaemia or Torsade de Pointes
Vital signs or 12-lead ECG values outside the acceptable range
Abnormal Holter ECG
Drug or alcohol abuse

Summary

Conditions
Dyslipidemia
Type
Interventional
Phase
Phase 1
Design
  • Allocation: Randomized
  • Intervention Model: Single Group Assignment
  • Masking: Double (Participant, Investigator)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 55 years
Gender
Both males and females

Inclusion Criterias

Women of non-childbearing potential
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
...
Women of non-childbearing potential
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
Caucasian men aged 18-55 years and ≥65 years
Japanese men aged 18-55 years

Exclusion Criterias

Consuming food or drinks containing grapefruit or cranberry within the 7 days before dosing
Clinically relevant abnormal findings at the screening assessment
Participation in other clinical trials, or loss of more than 450 mL blood within the previous 3 months
...
Consuming food or drinks containing grapefruit or cranberry within the 7 days before dosing
Clinically relevant abnormal findings at the screening assessment
Participation in other clinical trials, or loss of more than 450 mL blood within the previous 3 months
Positive tests for hepatitis B and C, HIV 1 and 2
Severe adverse reaction or allergy to any drug
Positive urine pregnancy test (women only)
Possibility that volunteer would not cooperate
Smoking within the 6 months before dosing with TA-8995 (Caucasian subjects), or smoking more than 10 cigarettes daily (Japanese subjects)
HDL-C level ≥2.59 mmol/L
Clinically relevant abnormal medical history or concurrent medical condition
Over-the-counter or prescribed medication up to 7 days or 5 half-lives (whichever was longer) before dosing with TA-8995
Family history of long QT syndrome, hypokalaemia or Torsade de Pointes
Vital signs or 12-lead ECG values outside the acceptable range
Abnormal Holter ECG
Drug or alcohol abuse

Locations

London, NW10 7EW
London, NW10 7EW

Tracking Information

NCT #
NCT01878474
Collaborators
Not Provided
Investigators
  • Principal Investigator: Steve Warrington, MA MD FRCP FFPM Hammersmith Medicines Research
  • Steve Warrington, MA MD FRCP FFPM Hammersmith Medicines Research