Bioequivalence Study of Idalopirdine in Healthy Subjects

Phase 1

Withdrawn

• Conditions: Bioequivalence
• Interventions: Drug: Idalopirdine commercial tablet (test); Drug: Idalopirdine clinical tablet (reference)

• Registration Number: NCT02894515
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

The purpose of this study is to investigate whether 2 different tablet compositions are similar regarding absorption (uptake) in the body. One composition was used in the clinical development program and the other is intended for the market

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Study First Submitted: 2016-09-05
• Study First Submitted QC: 2016-09-05
• Study First Posted: 2016-09-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-10
• Last Update Posted: 2016-11-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Healthy men and women with a body mass index (BMI) of >18.5 and <30 kg/m2.

Exclusion Criteria

• pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test/Reference	Idalopirdine clinical tablet (reference)	Single dose of commercial tablet Treatment A (Test) in period I. Followed by single dose of clinical tablet Treatment B (Reference) in period II. First and second dose administration will be separated by a washout period of at least 7 days
Test/Reference	Idalopirdine commercial tablet (test)	Single dose of commercial tablet Treatment A (Test) in period I. Followed by single dose of clinical tablet Treatment B (Reference) in period II. First and second dose administration will be separated by a washout period of at least 7 days
Reference/Test	Idalopirdine clinical tablet (reference)	Single dose of clinical tablet Treatment B (Reference) in period I. Followed by single dose of commercial tablet Treatment A (Test) in period II. First and second dose administration will be separated by a washout period of at least 7 days
Reference/Test	Idalopirdine commercial tablet (test)	Single dose of clinical tablet Treatment B (Reference) in period I. Followed by single dose of commercial tablet Treatment A (Test) in period II. First and second dose administration will be separated by a washout period of at least 7 days

Primary Outcome Measures

Name	Time	Method
Area under the idalopirdine plasma concentration-time curve (AUC0-t) from time zero to the last quantifiable concentration post-dose	baseline to 72 hours post-dose
Maximum observed concentration of idalopirdine (Cmax)	baseline to 72 hours post-dose

Secondary Outcome Measures

Name	Time	Method
Time to occurrence of Cmax (tmax)	baseline to 72 hours post-dose
Area under the idalopirdine plasma concentration-time curve (AUC0-inf) from time zero to infinity	baseline to 72 hours post-dose
Apparent elimination half-life (t1/2)	baseline to 72 hours post-dose

Trial Locations

Locations (1)

GB1050; 🇬🇧 Leeds, United Kingdom