Drug Interaction Study Between AZD3355 and Nexium

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00684190
First received: May 22, 2008
Last updated: December 2, 2010
Last verified: December 2010
  Purpose

The purpose of the study is to evaluate if AZD3355 and Nexium interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.


Condition Intervention Phase
Gastroesophageal Reflux Disease
Drug: AZD3355
Drug: Esomeprazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: An Open, Randomised, Three Period Cross, Single Centre, Phase 1 Pharmacokinetic Interaction Study of the Reflux Inhibitor AZD3355 150 mg Bid and Esomeprazole 40 mg od After 7 Days of Treatment in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • PK variables [ Time Frame: Frequent sampling occasions during day 7 each treatment period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 4-BOH cholesterol [ Time Frame: Sampling occasions during day 7 one treatment period (AZD3355 alone) ] [ Designated as safety issue: No ]
  • Safety variables (adverse events, blood pressure, pulse, safety lab) [ Time Frame: During the whole treatment period ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: March 2008
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD3355 150 mg
Drug: AZD3355
150 mg bid, oral, 7 days
Other Name: Lesogaberan
Experimental: 2
Esomeprazole 40mg
Drug: Esomeprazole
40 mg od, oral, 7 days
Other Name: Nexium
Experimental: 3
AZD3355 150mg/Esomeprazole 40mg
Drug: AZD3355
150 mg bid, oral, 7 days
Other Name: Lesogaberan
Drug: Esomeprazole
40 mg od, oral, 7 days
Other Name: Nexium

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Provision of written informed consent
  • Females no childbearing potential
  • Clinically normal physical findings

Exclusion Criteria:

  • Clinically significant illness within 2 weeks prior to the first dose of investigational product
  • History of clinically significant disease
  • Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684190

Locations
Sweden
Research Site
Uppsala, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Eva Ersdal, PhD AstraZeneca R&D, Mölndal, Sweden
Principal Investigator: Jan Vouis, MD Quintiles AB, Uppsala, Sweden
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Debra G. Silberg, MD, PhD, Medical Science Director, AZD3355, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00684190     History of Changes
Other Study ID Numbers: D9120C00016, EudraCt nr 2007-007128-16
Study First Received: May 22, 2008
Last Updated: December 2, 2010
Health Authority: Sweden: Medical Products Agency

Keywords provided by AstraZeneca:
Reflux Inhibitor
GERD
PPI Interaction

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esomeprazole
Lesogaberan
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA-A Receptor Agonists
GABA Agonists
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014