Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 With Single, Escalating Doses in Healthy Subjects

Dyslipidemia Clinical Trial

Official title:

A Randomised, Double-blind, Placebo-controlled, First Time-in-humans Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single, Escalating Doses of TA-8995 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878474
• Other study ID #: TA-8995-01
• Status: Completed
• Phase: Phase 1
• First received: June 4, 2013
• Last updated: June 12, 2013
• Start date: March 2008
• Est. completion date: June 2009

Study information

• Verified date: June 2013
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and tolerability of single doses of TA-8995 in healthy Caucasian and Japanese volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Caucasian men aged 18-55 years and =65 years

• Women of non-childbearing potential

• Japanese men aged 18-55 years

• Subjects were deemed healthy on the basis of medical history, physical examination, Electrocardiogram (ECG), vital signs and safety tests of blood and urine

• Subjects were able to give fully informed written consent

Exclusion Criteria:

• HDL-C level =2.59 mmol/L

• Abnormal Holter ECG

• Family history of long QT syndrome, hypokalaemia or Torsade de Pointes

• Vital signs or 12-lead ECG values outside the acceptable range

• Positive tests for hepatitis B and C, HIV 1 and 2

• Positive urine pregnancy test (women only)

• Severe adverse reaction or allergy to any drug

• Drug or alcohol abuse

• Smoking within the 6 months before dosing with TA-8995 (Caucasian subjects), or smoking more than 10 cigarettes daily (Japanese subjects)

• Over-the-counter or prescribed medication up to 7 days or 5 half-lives (whichever was longer) before dosing with TA-8995

• Consuming food or drinks containing grapefruit or cranberry within the 7 days before dosing

• Participation in other clinical trials, or loss of more than 450 mL blood within the previous 3 months

• Clinically relevant abnormal findings at the screening assessment

• Clinically relevant abnormal medical history or concurrent medical condition

• Possibility that volunteer would not cooperate

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
TA-8905 5, 10, 25, 50 (fasted and fed), 100 and 150 mg
• TA-8995
Drug: TA-8995 25 mg
• TA-8995
Drug: TA-8995 25 mg
• TA-8995
Drug: TA-8995 25, 50, 100 and 150 mg
• Placebo
Single ascending dose in Caucasian men
• Placebo
Age-effect in Caucasian men
• Placebo
Gender-effect in Caucasian women
• Placebo
Single ascending dose in Japanese men

Locations

Country	Name	City	State
United Kingdom	Hammersmith Medicines Research (HMR)	London

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

United Kingdom, 

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	Peak concentration (ng/mL) of TA-8995		336 hours post dose	No
Primary	Time of peak concentration (hr) of TA-8995		336 hours post dose	No
Primary	Area under the concentration-time curve (mg/L·hr) up to 24 h (AUC0-24), 72 h (AUC0-72), 168 h (AUC0-168), 336 h (AUC0-336) and infinity (AUC0-8) of TA-8995		336 hours post dose	No
Secondary	Plasma Cholesterol Ester Transfer Protein (CETP) activity (%) and concentration (mg/mL)		336 hours post dose	No