Gastroesophageal Reflux DiseasePhase 1NCT00684190
Drug Interaction Study Between AZD3355 and Nexium
A Phase 1 study testing AZD3355 and Esomeprazole in people with Gastroesophageal Reflux Disease, run by AstraZeneca at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- AZD3355 and Esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2008to Jun 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provision of written informed consent
- Females no childbearing potential
- Clinically normal physical findings
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- AZD3355, Esomeprazole
- Keywords
- Reflux Inhibitor, GERD, PPI Interaction
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD3355Drug
Also called Lesogaberan
150 mg bid, oral, 7 days
EsomeprazoleDrug
Also called Nexium
40 mg od, oral, 7 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AZD3355 150 mg Receives: Drug: AZD3355 |
| 2 | Experimental | Esomeprazole 40mg Receives: Drug: Esomeprazole |
| 3 | Experimental | AZD3355 150mg/Esomeprazole 40mg Receives: Drug: AZD3355; Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK variables
Measured: Frequent sampling occasions during day 7 each treatment period
Secondary outcomes (2)
4-BOH cholesterol
Measured: Sampling occasions during day 7 one treatment period (AZD3355 alone)
Safety variables (adverse events, blood pressure, pulse, safety lab)
Measured: During the whole treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Eva Ersdal, PhD, Study director, AstraZeneca R&D, Mölndal, SwedenJan Vouis, MD, Principal investigator, Quintiles AB, Uppsala, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684190
- Sponsor's protocol ID
- D9120C00016
- Other IDs
- EudraCt nr 2007-007128-16
- Status last verified
- Dec 2010
- First submitted
- 22 May 2008
- Last updated
- 3 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Niazi M, Silberg DG, Miller F, Ruth M, Holmberg AA. Evaluation of the pharmacokinetic interaction between lesogaberan (AZD3355) and esomeprazole in healthy subjects. Drugs R D. 2010;10(4):243-51. doi: 10.2165/11588180-000000000-00000.
PubMed 21171670
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00684190
- Acronym / sponsor ID
- D9120C00016
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Reflux Inhibitor, GERD, PPI Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 26 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AZD3355AZD3355 150 mg |
| 2 | Experimental | Drug: EsomeprazoleEsomeprazole 40mg |
| 3 | Experimental | Drug: AZD3355, Drug: EsomeprazoleAZD3355 150mg/Esomeprazole 40mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Provision of written informed consent
- Females no childbearing potential
- Clinically normal physical findings
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD3355Also: Lesogaberan150 mg bid, oral, 7 days | Drug | 1, 3 |
| EsomeprazoleAlso: Nexium40 mg od, oral, 7 days | Drug | 2, 3 |
Primary outcome
PK variables
Time frame: Frequent sampling occasions during day 7 each treatment period
2 secondary outcomes
4-BOH cholesterol
Time frame: Sampling occasions during day 7 one treatment period (AZD3355 alone)
Safety variables (adverse events, blood pressure, pulse, safety lab)
Time frame: During the whole treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2010.
- Derived from this study: PubMed 21171670Niazi M, Silberg DG, Miller F, Ruth M, Holmberg AA. Evaluation of the pharmacokinetic interaction between lesogaberan (AZD3355) and esomeprazole in healthy subjects. Drugs R D. 2010;10(4):243-51. doi: 10.2165/11588180-000000000-00000.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Ersdal, PhD study director
AstraZeneca R&D, Mölndal, Sweden
Jan Vouis, MD principal investigator
Quintiles AB, Uppsala, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD3355 and Esomeprazole in people with Gastroesophageal Reflux Disease, run by AstraZeneca at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK variables (time frame: Frequent sampling occasions during day 7 each treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00684190, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2010.