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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02894515
Other study ID # 16976A
Secondary ID 2016-000405-37
Status Withdrawn
Phase Phase 1
First received September 5, 2016
Last updated November 10, 2016
Start date September 2016
Est. completion date September 2016

Study information

Verified date November 2016
Source H. Lundbeck A/S
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Idalopirdine commercial tablet (test)
single dose, 10 mg, oral
Idalopirdine clinical tablet (reference)
single dose, 10 mg, oral

Locations

Country Name City State
United Kingdom GB1050 Leeds

Sponsors (1)

Lead Sponsor Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary Maximum observed concentration of idalopirdine (Cmax) baseline to 72 hours post-dose No
Secondary Time to occurrence of Cmax (tmax) baseline to 72 hours post-dose No
Secondary Area under the idalopirdine plasma concentration-time curve (AUC0-inf) from time zero to infinity baseline to 72 hours post-dose No
Secondary Apparent elimination half-life (t1/2) baseline to 72 hours post-dose No
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