Evaluation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 After Multiple Doses in Healthy Subjects

NCT01879020 | Completed Phase 1

• 1 other identifier: TA-8995-E02
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of TA-8995 after multiple doses in healthy adult male subjects

Conditions

Dyslipidemia

Keywords

MT-8995; Dyslipidemia; Cholesteryl ester transfer proteins

Outcome Measures

Primary Outcomes (5)

• 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

• Area under the plasma concentration (AUC) versus time curve over the final dosing interval (AUC0-τ, Steady-state)

  7 days post the final dose

• The last time point 't' with a concentration Ct ≥ Lower limit quantification (LLQ) (AUC0-t, Steady-state)

  7 days post the final dose

Secondary Outcomes (2)

• Cholesterol ester transfer protein (CETP) activity (%)

  7 days post the final dose

• CETP concentration (mg/mL)

  4 hours after the first and the fibal dose

Study Arms (10)

TA-8995 1 mg

EXPERIMENTAL

Drug: TA-8995

TA-8995 2.5 mg

EXPERIMENTAL

Drug: TA-8995

TA-8995 5 mg

EXPERIMENTAL

Drug: TA-8995

TA-8995 10 mg

EXPERIMENTAL

Drug: TA-8995

TA-8995 25 mg

EXPERIMENTAL

Drug: TA-8995

Placebo (TA-8995 1mg)

PLACEBO COMPARATOR

Drug: Placebo

Placebo (TA-8995 2.5mg)

PLACEBO COMPARATOR

Drug: Placebo

Placebo (TA-8995 5mg)

PLACEBO COMPARATOR

Drug: Placebo

Placebo (TA-8995 10mg)

PLACEBO COMPARATOR

Drug: Placebo

Placebo (TA-8995 25mg)

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TA-8995 DRUG

Drug: TA-8995 1mg

TA-8995 1 mg

Placebo DRUG

Placebo (TA-8995 1mg)

Placebo (TA-8995 1mg)

Eligibility Criteria

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

You may qualify if:

• Free from any clinically significant illness or disease as determined by their medical history, physical examination, laboratory and other tests and as judged by the Investigator.
• Between 18 - 55 years old.
• Male of Caucasian ethnic origin.
• Body mass index (BMI) in the range of 19 - 33 kg/m² and had a minimum weight of 50 kg. Subjects with a BMI in the range 30.0 - 33.0 kg/m² had to have a waist measurement of ≤ 91 cm.

You may not qualify if:

• High density lipoprotein (HDL)-C level of greater or equal to 2.59 mmol/L (≥ 100 mg/dL) at Screening.
• Family history of long QT syndrome, hypokalaemia or Torsades de Pointes
• Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease or history of any psychotic illness
• Presence or history of gastro-intestinal, hepatic or renal disease or any other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

Momentum Pharma Services GmbH

Hamburg, 22769, Germany

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

TA-8995

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Werner Weber, MD

  Momentum Pharma Services GmbH

  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: August 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: June 17, 2013

Record last verified: 2013-06

Locations

DE (1)