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CompletedNCT01879020Updated Jun 17, 2013

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

A Phase 1 interventional study of TA-8995 and TA-8995 in Dyslipidemia, sponsored by Mitsubishi Tanabe Pharma Corporation. Completed at 1 site in Germany. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-06-17.

Sponsored by Mitsubishi Tanabe Pharma Corporation · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study 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

02

Conditions studied

  • Dyslipidemia

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Keywords

  • MT-8995
  • Dyslipidemia
  • Cholesteryl ester transfer proteins
03

In context

Dyslipidemias

1,073 studies on the registry are indexed under Dyslipidemias; 158 are open to participants now.

This study's enrollment of 61 is below the median of 99 across 842 interventional studies indexed under Dyslipidemias.

Browse Dyslipidemias studies →

Lead sponsor

Mitsubishi Tanabe Pharma Corporation is the lead sponsor of 40 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • High density lipoprotein (HDL)-C level of greater or equal to 2.59 mmol/L (≥ 100 mg/dL) at Screening.
  • Abnormal Electrocardiogram (ECG) at Screening or Day -1 including a QTc ≥ 430 ms (The QTc-interval was calculated automatically according to Bazett's formula. In the case of results of ≥ 430 ms, QTc was additionally calculated manually using Fridericia's formula which was used as an exclusion criterion).
  • 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Investigator)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    TA-8995 1 mg

    Drug: TA-8995

  • Experimental
    TA-8995 2.5 mg

    Drug: TA-8995

  • Experimental
    TA-8995 5 mg

    Drug: TA-8995

  • Experimental
    TA-8995 10 mg

    Drug: TA-8995

  • Experimental
    TA-8995 25 mg

    Drug: TA-8995

  • Placebo comparator
    Placebo (TA-8995 1mg)

    Drug: Placebo

  • Placebo comparator
    Placebo (TA-8995 2.5mg)

    Drug: Placebo

  • Placebo comparator
    Placebo (TA-8995 5mg)

    Drug: Placebo

  • Placebo comparator
    Placebo (TA-8995 10mg)

    Drug: Placebo

  • Placebo comparator
    Placebo (TA-8995 25mg)

    Drug: Placebo

Interventions

  • DrugTA-8995

    Drug: TA-8995 1mg

  • DrugTA-8995

    Drug: TA-8995 2.5mg

  • DrugTA-8995

    Drug: TA-8995 5mg

  • DrugTA-8995

    Drug: TA-8995 10mg

  • DrugTA-8995

    Drug: TA-8995 25mg

  • DrugPlacebo

    Placebo (TA-8995 1mg)

  • DrugPlacebo

    Placebo (TA-8995 2.5mg)

  • DrugPlacebo

    Placebo (TA-8995 5mg)

  • DrugPlacebo

    Placebo (TA-8995 10mg)

  • DrugPlacebo

    Placebo (TA-8995 25mg)

06

What researchers measure

Primary outcomes

  1. Number of participants with adverse events

    Time frame: 336 hours post dose

  2. Laboratory tests (haematology, biochemistry and urinalysis)

    Time frame: 336 hours post dose

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

    Time frame: 336 hours post dose

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

    Time frame: 7 days post the final dose

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

    Time frame: 7 days post the final dose

Secondary outcomes

  1. Cholesterol ester transfer protein (CETP) activity (%)

    Time frame: 7 days post the final dose

  2. CETP concentration (mg/mL)

    Time frame: 4 hours after the first and the fibal dose

07

Study locations

1 site
  • Momentum Pharma Services GmbH
    Hamburg, 22769, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01879020
Lead sponsor
Mitsubishi Tanabe Pharma Corporation
Responsible party
Sponsor
First posted
Jun 17, 2013
Start date
Aug 2009
Primary completion
Jun 2010
Completion
Jun 2010
Last update
Jun 17, 2013

Study contacts

Werner Weber, MD
principal investigator · Momentum Pharma Services GmbH

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2013. You cannot join it, but the record below documents what was studied.

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