Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 After Multiple Doses in Healthy Subjects

Dyslipidemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01879020
• Other study ID #: TA-8995-E02
• Status: Completed
• Phase: Phase 1
• First received: June 4, 2013
• Last updated: June 12, 2013
• Start date: August 2009
• Est. completion date: June 2010

Study information

• Verified date: June 2013
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Drug:
• TA-8995
Drug: TA-8995 1mg
• TA-8995
Drug: TA-8995 2.5mg
• TA-8995
Drug: TA-8995 5mg
• TA-8995
Drug: TA-8995 10mg
• TA-8995
Drug: TA-8995 25mg
• Placebo
Placebo (TA-8995 1mg)
• Placebo
Placebo (TA-8995 2.5mg)
• Placebo
Placebo (TA-8995 5mg)
• Placebo
Placebo (TA-8995 10mg)
• Placebo
Placebo (TA-8995 25mg)

Locations

Country	Name	City	State
Germany	Momentum Pharma Services GmbH	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		336 hours post dose	Yes
Primary	Laboratory tests (haematology, biochemistry and urinalysis)		336 hours post dose	Yes
Primary	Vital signs (supine systolic and diastolic blood pressure, heart rate and body temperature)		336 hours post dose	Yes
Primary	Area under the plasma concentration (AUC) versus time curve over the final dosing interval (AUC0-t, Steady-state)		7 days post the final dose	No
Primary	The last time point 't' with a concentration Ct = Lower limit quantification (LLQ) (AUC0-t, Steady-state)		7 days post the final dose	No
Secondary	Cholesterol ester transfer protein (CETP) activity (%)		7 days post the final dose	No
Secondary	CETP concentration (mg/mL)		4 hours after the first and the fibal dose	No