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

NCT01878474 | Completed Phase 1

• 1 other identifier: TA-8995-01
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemia

Keywords

MT-8995; Dyslipidemia; Cholesteryl ester transfer proteins

Outcome Measures

Primary Outcomes (6)

• Number of participants with adverse events

  336 hours post dose

• Laboratory tests (haematology, biochemistry and urinalysis)

  336 hours post dose

• Vital signs (supine systolic and diastolic blood pressure, heart rate and body temperature)

  336 hours post dose

• Peak concentration (ng/mL) of TA-8995

  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

Secondary Outcomes (1)

• Plasma Cholesterol Ester Transfer Protein (CETP) activity (%) and concentration (mg/mL)

  336 hours post dose

Study Arms (8)

Single ascending dose in Caucasian men

EXPERIMENTAL

Drug: TA-8995

Age-effect in Caucasian men

EXPERIMENTAL

Drug: TA-8995

Gender-effect in Caucasian women

EXPERIMENTAL

Drug: TA-8995

Single ascending dose in Japanese men

EXPERIMENTAL

Drug: TA-8995

Placebo: Single ascending dose in Caucasian men

PLACEBO COMPARATOR

Drug: Placebo

Placebo: Age-effect in Caucasian men

PLACEBO COMPARATOR

Drug: Placebo

Placeo: Gender-effect in Caucasian women

PLACEBO COMPARATOR

Drug: Placebo

Placebo: Single ascending dose in Japanese men

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TA-8995 DRUG

TA-8905 5, 10, 25, 50 (fasted and fed), 100 and 150 mg

Single ascending dose in Caucasian men

Placebo DRUG

Single ascending dose in Caucasian men

Placebo: Single ascending dose in Caucasian men

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Hammersmith Medicines Research (HMR)

London, NW10 7EW, United Kingdom

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

TA-8995

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Steve Warrington, MA MD FRCP FFPM

  Hammersmith Medicines Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 17, 2013
• Study Start: March 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 17, 2013

Record last verified: 2013-06

Locations

GB (1)