The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of TA-8995 after multiple doses in healthy adult male subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
61
Momentum Pharma Services GmbH
Hamburg, Germany
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
Area under the plasma concentration (AUC) versus time curve over the final dosing interval (AUC0-τ, Steady-state)
Time frame: 7 days post the final dose
The last time point 't' with a concentration Ct ≥ Lower limit quantification (LLQ) (AUC0-t, Steady-state)
Time frame: 7 days post the final dose
Cholesterol ester transfer protein (CETP) activity (%)
Time frame: 7 days post the final dose
CETP concentration (mg/mL)
Time frame: 4 hours after the first and the fibal dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Drug: TA-8995 10mg
Drug: TA-8995 25mg
Placebo (TA-8995 1mg)
Placebo (TA-8995 2.5mg)
Placebo (TA-8995 5mg)
Placebo (TA-8995 10mg)
Placebo (TA-8995 25mg)