Poster Presentations
at the 2014 ASCPT Annual Meeting:

Implementation of Pharmacogenetics in Early Stage Clinical Trials:
An Emerging Trend for Accelerated Characterization of New Entities

Author/Presenter: Mira Francis1
Author: M. Francis1, C. Dussault1, J. Massicotte1, E. Sicard1, M. Lefebvre1


1Algorithme Pharma, Laval, QC, Canada

ABSTRACT:

Recently, genotyping and phenotyping of a study population have been implemented to investigate the impact of genetic differences in the drug metabolic pathways on the individual pharmacokinetic (PK) profile for new chemical entities and their metabolites in early stage clinical trials.

Session:
POSTER SESSION I

Poster Number:
29

Presentation Date/Time:
March 20, 2014
7:30 AM – 9:00 AM
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The Safety and Pharmacokinetics of Meloxicam in Combination with Omeprazole Compared to Respective Monotherapies in Healthy Volunteers

Author: J. Massicotte1, A. Fortier1, S. Boily1, J. M. Paquette1, L. Sayegh1, E. Sicard1, M. Lefebvre1, J. Hofmann2

1Algorithme Pharma, Laval, QC, Canada
2Zentiva, k.s., Prague, Czech Republic

ABSTRACT:

The development of fixed-dose combination (FDC) products in which the drugs have been previously approved individually is becoming important as such products are useful in the management of chronic diseases. These programs are usually submitted in EU using the Article 10b of 2001/83/EC and in US by the 505(b)(2) NDA route. This study was conducted to assess the PK profile of meloxicam and omeprazole following a single oral dose under fed conditions of a FDC capsule of meloxicam/omeprazole in comparison to the co-administration of its marketed monocomponents.

Session:
POSTER SESSION II

Poster Number:
1

Presentation Date/Time:
March 21, 2014
11:45 AM – 1:15 PM
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Safety, Tolerability and Pharmacokinetic of GIC-1001 Following Multiple Ascending Doses Administrations Through an Adaptive First In Human Study in Healthy Volunteers

Author: J. M. Paquette1, M. Rufiange1, A. Ait Sadoune1, E. Sicard1, J. Massicotte1, M. Lefebvre1, P. Colin2, M. Ranger2

1Algorithme Pharma, Laval, QC, Canada
22gIcare Pharma Inc., Montreal, QC, Canada

ABSTRACT:

GIC-1001 is a new drug indicated for the management of visceral pain in patients undergoing sedation-free, full colonoscopy. One of the objectives of this study was to evaluate the safety and pharmacokinetics of GIC-1001 following multiple ascending doses (MAD) in healthy volunteers.

Session:
POSTER SESSION II

Poster Number:
2

Presentation Date/Time:
March 21, 2014
11:45 AM – 11:15 PM
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A Phase I Adaptive Design Study to Assess Safety, Tolerability and Pharmacokinetics of Single Ascending Oral Doses of GIC-1001 in Healthy Volunteers

Author: L. Sayegh1, M. Rufiange1, A. Ait Sadoune1, E. Sicard1, J. Massicotte1, M. Lefebvre1, P. Colin2, M. Ranger2

1Algorithme Pharma, Laval, QC, Canada
22gIcare Pharma Inc., Montreal, QC, Canada

ABSTRACT:

GIC-1001 is a new drug indicated for the management of visceral pain in patients undergoing sedation-free, full colonoscopy. Two study objectives were to evaluate the safety and pharmacokinetics of GIC-1001 following single ascending doses (SAD) in the fasting state and to evaluate the influence of food on its bioavailability.

Session:
POSTER SESSION II

Poster Number:
8

Presentation Date/Time:
March 21, 2014
11:45 AM – 1:15 PM
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