Drug-Drug Interaction Study of TRK-100STP

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: TRK-100STP (BERASUS LA); Drug: AST-120 (Kremezin®)

• Registration Number: NCT00719758
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

The purpose of this study is to evaluate the effect of AST-120 on the PK of TRK-100STP, and to evaluate the safety and tolerability of TRK-100STP alone or in combination with AST-120

Detailed Description

Non-blinded, randomized and crossover study to evaluate pharmacokinetic interaction between TRK-100STP and AST-120 in different administration condition. Nonelderly adult volunteers will receive TRK-100STP with or without AS-T120 after meal. Safety parameters will concurrently be measured.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-18
• Study First Submitted QC: 2008-07-21
• Study First Posted: 2008-07-22
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2008-10
• Last Update Submitted: 2008-10-09
• Last Update Posted: 2008-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• Provision of written informed consent
• Body Mass Index (BMI) of ≥17.6 to ≤26.4 kg/m2 and weight of ≥50 to ≤80 kg

Exclusion Criteria

• Clinical abnormal physical findings, including BP, pulse rate, ECG and laboratory assessments
• Receives any investigational medicine within 120 days before screening
• Recent blood donor

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	TRK-100STP (BERASUS LA)	Cross-over study
1	AST-120 (Kremezin®)	Cross-over study

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic profile	1 day

Secondary Outcome Measures

Name	Time	Method
Safety parameters (vital signs, ECG, laboratory tests)	1 day