NCT02174510

A Pharmacokinetic Study of Lurasidone After Single Oral Administration in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

To evaluate the pharmacokinetic (PK) characteristics of lurasidone after single oral administration of different doses in healthy Chinese subjects. To evaluate the safety and tolerability of lurasidone after single oral administration of different doses in healthy Chinese subjects.

Detailed description

Single administration, double-blinded, placebo-controlled (3 subjects in each group will take placebo) and 3 dose groups (20 mg, 40 mg and 80 mg). There are three groups which are 20mg lurasidone or placebo, 40mg lurasidone or placebo and 80mg lurasidone or placebo. This study comprises a screening period (between signing of the informed consent form and Day -2), baseline period (Day -1), treatment period (Days 1-3) and ending of study examination period (Days 8-11 after the last sample collection for PK evaluation).

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	20mg lurasidone	single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.
DRUG	40mg lurasidone	single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.
DRUG	80mg lurasidone	single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.
DRUG	placebo

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2014-06-25
• Last updated: 2019-01-11
• Results posted: 2019-01-11

Locations

1 site across 1 country: China