NCT01878474

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

• Dyslipidemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2013-06-17
• Last updated: 2013-06-17

Locations

1 site across 1 country: United Kingdom