Clinical trial NCT01878474: Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 With Single, Escalating Doses in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemia
Keywords: MT-8995
Dyslipidemia
Cholesteryl ester transfer proteins
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2013-06-17
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 336 hours post dose
measure: Laboratory tests (haematology, biochemistry and urinalysis)
timeFrame: 336 hours post dose
measure: Vital signs (supine systolic and diastolic blood pressure, heart rate and body temperature)
timeFrame: 336 hours post dose
measure: Peak concentration (ng/mL) of TA-8995
timeFrame: 336 hours post dose
measure: Time of peak concentration (hr) of TA-8995
timeFrame: 336 hours post dose
measure: 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
timeFrame: 336 hours post dose
Secondary outcomes:
measure: Plasma Cholesterol Ester Transfer Protein (CETP) activity (%) and concentration (mg/mL)
timeFrame: 336 hours post dose
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Hammersmith Medicines Research (HMR)
Study officials:
affiliation: Hammersmith Medicines Research
name: Steve Warrington, MA MD FRCP FFPM
role: PRINCIPAL_INVESTIGATOR
References: