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

NCT01878474 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2013-06-17

No results posted yet for this study

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

Interventions

DRUG

TA-8995

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

DRUG

TA-8995

Drug: TA-8995 25 mg

DRUG

TA-8995

Drug: TA-8995 25 mg

DRUG

TA-8995

Drug: TA-8995 25, 50, 100 and 150 mg

DRUG

Placebo

Single ascending dose in Caucasian men

DRUG

Placebo

Age-effect in Caucasian men

DRUG

Placebo

Gender-effect in Caucasian women

DRUG

Placebo

Single ascending dose in Japanese men

Sponsors & Collaborators

  • Mitsubishi Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • Steve Warrington, MA MD FRCP FFPM · Hammersmith Medicines Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01878474 on ClinicalTrials.gov