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

Phase 1

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: TA-8995; Drug: Placebo

• Registration Number: NCT01878474
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2013-06
• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-12
• Last Update Submitted: 2013-06-12
• Study First Posted: 2013-06-17
• Last Update Posted: 2013-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single ascending dose in Japanese men	TA-8995	-
Placebo: Single ascending dose in Japanese men	Placebo	-
Single ascending dose in Caucasian men	TA-8995	-
Gender-effect in Caucasian women	TA-8995	-
Placebo: Single ascending dose in Caucasian men	Placebo	-
Placebo: Age-effect in Caucasian men	Placebo	-
Placeo: Gender-effect in Caucasian women	Placebo	-
Age-effect in Caucasian men	TA-8995	-

Primary Outcome Measures

Name	Time	Method
Vital signs (supine systolic and diastolic blood pressure, heart rate and body temperature)	336 hours post dose
Number of participants with adverse events	336 hours post dose
Laboratory tests (haematology, biochemistry and urinalysis)	336 hours post dose
Time of peak concentration (hr) of TA-8995	336 hours post dose
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-∞) of TA-8995	336 hours post dose
Peak concentration (ng/mL) of TA-8995	336 hours post dose

Secondary Outcome Measures

Name	Time	Method
Plasma Cholesterol Ester Transfer Protein (CETP) activity (%) and concentration (mg/mL)	336 hours post dose

Trial Locations

Locations (1)

Hammersmith Medicines Research (HMR); 🇬🇧 London, United Kingdom