The purpose of this study is to assess the safety and tolerability of single doses of TA-8995 in healthy Caucasian and Japanese volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
Hammersmith Medicines Research (HMR)
London, United Kingdom
Number of participants with adverse events
Time frame: 336 hours post dose
Laboratory tests (haematology, biochemistry and urinalysis)
Time frame: 336 hours post dose
Vital signs (supine systolic and diastolic blood pressure, heart rate and body temperature)
Time frame: 336 hours post dose
Peak concentration (ng/mL) of TA-8995
Time frame: 336 hours post dose
Time of peak concentration (hr) of TA-8995
Time frame: 336 hours post dose
Area under the concentration-time curve (mg/L・hr) up to 24 h (AUC0-24), 72 h (AUC0-72), 168 h (AUC0-168), 336 h (AUC0-336) and infinity (AUC0-∞) of TA-8995
Time frame: 336 hours post dose
Plasma Cholesterol Ester Transfer Protein (CETP) activity (%) and concentration (mg/mL)
Time frame: 336 hours post dose
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Drug: TA-8995 25, 50, 100 and 150 mg
Single ascending dose in Caucasian men
Age-effect in Caucasian men
Gender-effect in Caucasian women
Single ascending dose in Japanese men