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

Mitsubishi Tanabe Pharma

Status and phase: Completed; Phase 1

Conditions: Dyslipidemia

Treatments: Drug: TA-8995; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01878474

TA-8995-01

Details and patient eligibility

About

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

Enrollment: 96 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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96 participants in 8 patient groups, including a placebo group

Single ascending dose in Caucasian men

Experimental group

Treatment:

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

Age-effect in Caucasian men

Experimental group

Treatment:

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

Gender-effect in Caucasian women

Experimental group

Treatment:

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

Single ascending dose in Japanese men

Experimental group

Treatment:

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

Drug: TA-8995

Placebo: Single ascending dose in Caucasian men

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Placebo: Age-effect in Caucasian men

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Placeo: Gender-effect in Caucasian women

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo

Placebo: Single ascending dose in Japanese men

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Placebo

Drug: Placebo

Drug: Placebo