Clinical trial NCT01879020: Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 After Multiple Doses in Healthy Subjects
Official title: A Randomised Double-blind, Placebo-controlled, Ascending-dose, Phase I Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 After Multiple Doses in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemia
Keywords: MT-8995
Dyslipidemia
Cholesteryl ester transfer proteins
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2013-06-17
Enrollment: 61
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 336 hours post dose
measure: Laboratory tests (haematology, biochemistry and urinalysis)
timeFrame: 336 hours post dose
measure: Vital signs (supine systolic and diastolic blood pressure, heart rate and body temperature)
timeFrame: 336 hours post dose
measure: Area under the plasma concentration (AUC) versus time curve over the final dosing interval (AUC0-τ, Steady-state)
timeFrame: 7 days post the final dose
measure: The last time point 't' with a concentration Ct ≥ Lower limit quantification (LLQ) (AUC0-t, Steady-state)
timeFrame: 7 days post the final dose
Secondary outcomes:
measure: Cholesterol ester transfer protein (CETP) activity (%)
timeFrame: 7 days post the final dose
measure: CETP concentration (mg/mL)
timeFrame: 4 hours after the first and the fibal dose
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Momentum Pharma Services GmbH
Study officials:
affiliation: Momentum Pharma Services GmbH
name: Werner Weber, MD
role: PRINCIPAL_INVESTIGATOR
References: