Dyslipidemia
Conditions
Keywords
MT-8995, Dyslipidemia, Cholesteryl ester transfer proteins
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
Interventions
DRUGTA-8995
Drug: TA-8995 1mg
DRUGPlacebo
Placebo (TA-8995 1mg)
Sponsors
Tanabe Pharma Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Laboratory tests (haematology, biochemistry and urinalysis) | 336 hours post dose |
| Area under the plasma concentration (AUC) versus time curve over the final dosing interval (AUC0-τ, Steady-state) | 7 days post the final dose |
| The last time point 't' with a concentration Ct ≥ Lower limit quantification (LLQ) (AUC0-t, 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany
Outcome results
None listed