Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 After Multiple Doses in Healthy Subjects
- Registration Number
- NCT01879020
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 61
Inclusion Criteria
- Free from any clinically significant illness or disease as determined by their medical history, physical examination, laboratory and other tests and as judged by the Investigator.
- Between 18 - 55 years old.
- Male of Caucasian ethnic origin.
- Body mass index (BMI) in the range of 19 - 33 kg/m² and had a minimum weight of 50 kg. Subjects with a BMI in the range 30.0 - 33.0 kg/m² had to have a waist measurement of ≤ 91 cm.
Exclusion Criteria
- High density lipoprotein (HDL)-C level of greater or equal to 2.59 mmol/L (≥ 100 mg/dL) at Screening.
- Abnormal Electrocardiogram (ECG) at Screening or Day -1 including a QTc ≥ 430 ms (The QTc-interval was calculated automatically according to Bazett's formula. In the case of results of ≥ 430 ms, QTc was additionally calculated manually using Fridericia's formula which was used as an exclusion criterion).
- Family history of long QT syndrome, hypokalaemia or Torsades de Pointes
- Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease or history of any psychotic illness
- Presence or history of gastro-intestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Placebo (TA-8995 1mg) Placebo - Placebo (TA-8995 25mg) Placebo - TA-8995 5 mg TA-8995 - Placebo (TA-8995 10mg) Placebo - TA-8995 2.5 mg TA-8995 - Placebo (TA-8995 2.5mg) Placebo - Placebo (TA-8995 5mg) Placebo - TA-8995 1 mg TA-8995 - TA-8995 25 mg TA-8995 - TA-8995 10 mg TA-8995 -
- Primary Outcome Measures
Name Time Method Area under the plasma concentration (AUC) versus time curve over the final dosing interval (AUC0-τ, Steady-state) 7 days post the final dose Number of participants with adverse events 336 hours post dose Vital signs (supine systolic and diastolic blood pressure, heart rate and body temperature) 336 hours post dose Laboratory tests (haematology, biochemistry and urinalysis) 336 hours post dose The last time point 't' with a concentration Ct ≥ Lower limit quantification (LLQ) (AUC0-t, Steady-state) 7 days post the final dose
- Secondary Outcome Measures
Name Time Method CETP concentration (mg/mL) 4 hours after the first and the fibal dose Cholesterol ester transfer protein (CETP) activity (%) 7 days post the final dose
Trial Locations
- Locations (1)
Momentum Pharma Services GmbH
🇩🇪Hamburg, Germany