NCT01879020

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

A Randomised Double-blind, Placebo-controlled, Ascending-dose, Phase I Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of TA-8995 After Multiple Doses in Healthy Adult Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	TA-8995	Drug: TA-8995 1mg
DRUG	TA-8995	Drug: TA-8995 2.5mg
DRUG	TA-8995	Drug: TA-8995 5mg
DRUG	TA-8995	Drug: TA-8995 10mg
DRUG	TA-8995	Drug: TA-8995 25mg
DRUG	Placebo	Placebo (TA-8995 1mg)
DRUG	Placebo	Placebo (TA-8995 2.5mg)
DRUG	Placebo	Placebo (TA-8995 5mg)
DRUG	Placebo	Placebo (TA-8995 10mg)
DRUG	Placebo	Placebo (TA-8995 25mg)

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2013-06-17
• Last updated: 2013-06-17

Locations

1 site across 1 country: Germany