RefluxPhase 2NCT01154634

Study to Investigate the Pharmacodynamic Effect of a Single Dose of AZD2516 in Healthy Male Subjects

A Phase 2 study testing AZD2516, 5 mg, AZD2516, 16 mg and AZD2516, 40 mg in people with Reflux, run by AstraZeneca at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to investigate the pharmacodynamic effect of AZD2516 in healthy male subjects. Read more about this study

Who is it for?: Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Reflux
What is being tested?: AZD2516, 5 mg, AZD2516, 16 mg and AZD2516, 40 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 20 participants
Where: 2 sitesin 2 countries
Study dates: May 2010to Sep 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Provision of signed informed consent
Healthy male subjects
Age 18-45 years, inclusive

Who cannot join

Clinically significant illness within the 2 weeks prior to the first dose of study drug
History of clinically significant cardiovascular, respiratory, renal, hepatic, neurological, mental or gastrointestinal disease
Need for concomitant medications during the study

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Belgium1 site

Research Site
Leuven

Other trials in Belgium

Netherlands1 site

Research Site
Amsterdam

Other trials in Netherlands

About this study

Official title: A Double-blind, Randomized, Placebo-controlled, Two-centre, Phase IIa Pharmacodynamic Cross-over Study to Assess the Effect of AZD2516 on the Total Number of Reflux Episodes in Healthy Male Volunteers

The purpose of this study is to investigate the pharmacodynamic effect of AZD2516 in healthy male subjects.

Read the detailed description

A double-blind, randomized, placebo-controlled, two-centre, phase IIa pharmacodynamic cross-over study to assess the effect of AZD2516 on the total number of reflux episodes in healthy male volunteers.

Conditions: Reflux
Being tested: AZD2516, 5 mg, AZD2516, 16 mg, AZD2516, 40 mg, Placebo
Keywords: Pharmacodynamic effect, Reflux inhibition
Medical subject headings: Gastroesophageal Reflux

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZD2516, 5 mgDrug
Capsule, oral
AZD2516, 16 mgDrug
Capsule, oral
AZD2516, 40 mgDrug
Capsule, oral
PlaceboDrug
Capsule, oral

Study groups in NCT01154634
Study group	Role	What they receive
First 5 mg, then placebo, then 16 mg, then 40 mg	Experimental	period 1: AZD2516 5 mg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD2516 16 mg, period 6: washout, period 7: AZD2516 40 mg. Receives: Drug: AZD2516, 5 mg; Drug: AZD2516, 16 mg; Drug: AZD2516, 40 mg; Drug: Placebo
First 40 mg, then 16 mg, then placebo, then 5 mg	Experimental	period 1: AZD2516 40 mg, period 2: washout, period 3: AZD2516 16 mg, period 4: washout, period 5: placebo, period 6: washout, period 7: AZD2516 5 mg. Receives: Drug: AZD2516, 5 mg; Drug: AZD2516, 16 mg; Drug: AZD2516, 40 mg; Drug: Placebo
First 16 mg, then 5 mg, then 40 mg, then placebo	Experimental	period 1: AZD2516 16 mg, period 2: washout, period 3: AZD2516 5 mg, period 4: washout, period 5: AZD2516 40 mg, period 6: washout, period 7: placebo. Receives: Drug: AZD2516, 5 mg; Drug: AZD2516, 16 mg; Drug: AZD2516, 40 mg; Drug: Placebo
First placebo, then 40 mg, then 5 mg, then 16 mg	Experimental	period 1: placebo, period 2: washout, period 3: AZD2516 40 mg, period 4: washout, period 5: AZD2516 5 mg, period 6: washout, period 7: AZD2516 16 mg Receives: Drug: AZD2516, 5 mg; Drug: AZD2516, 16 mg; Drug: AZD2516, 40 mg; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Reflux Episodes 0 to 3 Hours Post Meal
Total number of reflux episodes 0 to 3 hours post meal
Measured: 0 to 3 hours post meal

Secondary outcomes (7)

Transient Lower Esophagus Sphincter Relaxations (TLESRs) 0 to 3 Hours Post Meal
Number of TLESRs 0 to 3 hours post meal were calculated based upon the manometric analysis fpr the 3-hour post-meal period.
Measured: 0 to 3 hours post meal
Area Under the Plasma Concentration Curve(AUC)
Area under the plasma concentration vs. time curve from time zero to 12-hours post dose calculated by loglinear trapezoidal method
Measured: 0 to 12 hours post dose
Average Plasma Concentration (C Average)
Average plasma concentration
Measured: 1 to 4 hours post dose
Maximum Plasma Concentration (Cmax)
Maximum plasma concentration
Measured: 0 to 12 hours post dose
Time to Maximum Plasma Concentration (Tmax)
Time to maximum plasma concentration (Tmax)
Measured: 0 to 12 hours post dose
Terminal Half-life (T Half)
Terminal half-life (T half)
Measured: 0 to 12 hours post dose
Clinically Relevant Change of Laboratory Variables
Number of participants with clinically relevant change of laboratory variables as judged by the responsible medical officer.
Measured: Pre-entry to follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Sep 2010

First posted1 Jul 2010 (estimated)
Study startMay 2010
Primary completionSep 2010
Study completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for RefluxStudies 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 2
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01154634
Sponsor's protocol ID: D3830C00001
Status last verified: Aug 2012
First submitted: 15 Jun 2010
Last updated: 30 Aug 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD

All Reflux trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Randomized, Placebo-controlled, Two-centre, Phase IIa Pharmacodynamic Cross-over Study to Assess the Effect of AZD2516 on the Total Number of Reflux Episodes in Healthy Male Volunteers
ClinicalTrials.gov ID: NCT01154634
Acronym / sponsor ID: D3830C00001
Conditions: Reflux
Keywords: Pharmacodynamic effect, Reflux inhibition
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 1 Jul 2010 (estimated)
Results: Posted 13 Aug 2012

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 this study is to investigate the pharmacodynamic effect of AZD2516 in healthy male subjects.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4

Arm	Type	Receives
First 5 mg, then placebo, then 16 mg, then 40 mg	Experimental	Drug: AZD2516, 5 mg, Drug: AZD2516, 16 mg, Drug: AZD2516, 40 mg, Drug: Placeboperiod 1: AZD2516 5 mg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD2516 16 mg, period 6: washout, period 7: AZD2516 40 mg.
First 40 mg, then 16 mg, then placebo, then 5 mg	Experimental	Drug: AZD2516, 5 mg, Drug: AZD2516, 16 mg, Drug: AZD2516, 40 mg, Drug: Placeboperiod 1: AZD2516 40 mg, period 2: washout, period 3: AZD2516 16 mg, period 4: washout, period 5: placebo, period 6: washout, period 7: AZD2516 5 mg.
First 16 mg, then 5 mg, then 40 mg, then placebo	Experimental	Drug: AZD2516, 5 mg, Drug: AZD2516, 16 mg, Drug: AZD2516, 40 mg, Drug: Placeboperiod 1: AZD2516 16 mg, period 2: washout, period 3: AZD2516 5 mg, period 4: washout, period 5: AZD2516 40 mg, period 6: washout, period 7: placebo.
First placebo, then 40 mg, then 5 mg, then 16 mg	Experimental	Drug: AZD2516, 5 mg, Drug: AZD2516, 16 mg, Drug: AZD2516, 40 mg, Drug: Placeboperiod 1: placebo, period 2: washout, period 3: AZD2516 40 mg, period 4: washout, period 5: AZD2516 5 mg, period 6: washout, period 7: AZD2516 16 mg

Who may qualify

Ages: 18 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Provision of signed informed consent
Healthy male subjects
Age 18-45 years, inclusive

Key exclusion criteria (3 listed)

Clinically significant illness within the 2 weeks prior to the first dose of study drug
History of clinically significant cardiovascular, respiratory, renal, hepatic, neurological, mental or gastrointestinal disease
Need for concomitant medications during the study

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
AZD2516, 5 mgCapsule, oral	Drug	First 16 mg, then 5 mg, then 40 mg, then placebo, First 40 mg, then 16 mg, then placebo, then 5 mg, First 5 mg, then placebo, then 16 mg, then 40 mg, First placebo, then 40 mg, then 5 mg, then 16 mg
AZD2516, 16 mgCapsule, oral	Drug	First 16 mg, then 5 mg, then 40 mg, then placebo, First 40 mg, then 16 mg, then placebo, then 5 mg, First 5 mg, then placebo, then 16 mg, then 40 mg, First placebo, then 40 mg, then 5 mg, then 16 mg
AZD2516, 40 mgCapsule, oral	Drug	First 16 mg, then 5 mg, then 40 mg, then placebo, First 40 mg, then 16 mg, then placebo, then 5 mg, First 5 mg, then placebo, then 16 mg, then 40 mg, First placebo, then 40 mg, then 5 mg, then 16 mg
PlaceboCapsule, oral	Drug	First 16 mg, then 5 mg, then 40 mg, then placebo, First 40 mg, then 16 mg, then placebo, then 5 mg, First 5 mg, then placebo, then 16 mg, then 40 mg, First placebo, then 40 mg, then 5 mg, then 16 mg

Primary outcome

Reflux Episodes 0 to 3 Hours Post Meal
Time frame: 0 to 3 hours post meal
Total number of reflux episodes 0 to 3 hours post meal

7 secondary outcomes

Transient Lower Esophagus Sphincter Relaxations (TLESRs) 0 to 3 Hours Post Meal
Time frame: 0 to 3 hours post meal
Area Under the Plasma Concentration Curve(AUC)
Time frame: 0 to 12 hours post dose
Average Plasma Concentration (C Average)
Time frame: 1 to 4 hours post dose
Maximum Plasma Concentration (Cmax)
Time frame: 0 to 12 hours post dose
Time to Maximum Plasma Concentration (Tmax)
Time frame: 0 to 12 hours post dose
Terminal Half-life (T Half)
Time frame: 0 to 12 hours post dose
Clinically Relevant Change of Laboratory Variables
Time frame: Pre-entry to follow-up

Results and safety

Results posted to the registry on 13 Aug 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
First 5 mg, Then Placebo, Then 16 mg, Then 40 mg	4	4
First 40 mg, Then 16 mg, Then Placebo, Then 5 mg	7	7
First 16 mg, Then 5 mg, Then 40 mg, Then Placebo	4	4
First Placebo, Then 40 mg, Then 5 mg, Then 16 mg	5	5

Primary outcome: Reflux Episodes 0 to 3 Hours Post Meal

Time frame: 0 to 3 hours post meal. Geometric mean (Full Range). Unit: Episodes

Measure	AZD2516 5 mg n = 19	AZD2516 16 mg n = 20	AZD2516 40 mg n = 20	Placebo n = 19
Value	15.1 (1 to 149)	12.5 (0 to 50)	11.0 (0 to 41)	12.7 (0 to 40)

Population analysed: Data from two subjects (one in arm AZD2516 5 mg, and one in arm Placebo) were excluded from efficacy analysis due to incorrect medication received.

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AZD2516 5 mg	0 of 20 (0%)	4 of 20 (20%)	Not reported
AZD2516 16 mg	0 of 20 (0%)	8 of 20 (40%)	Not reported
AZD2516 40 mg	0 of 20 (0%)	12 of 20 (60%)	Not reported
Placebo	0 of 20 (0%)	3 of 20 (15%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Reflux

RecruitingObservational study
A Study to Evaluate the Efficacy and Safety of Long-term Administration of K-CAB Tab./K-CAB ODT(Tegoprazan) 25 mg as Maintenance Therapy Following the Treatment of GERD
Maintenance Therapy Following Treatment for Gastroesophageal Reflux Disease(GERD)
Active, not recruitingObservational study
RETHINK REFLUX Registry
Gastroesophageal Reflux
Recruiting
Transcatheter Mitral Valve Replacement in Patients With Severe Symptomatic Mitral Regurgitation - APOLLO-EU Trial
Mitral Regurgitation
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD

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.

Mark Berner Hansen study director

AstraZeneca R&D Molndal

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AZD2516, 5 mg, AZD2516, 16 mg and AZD2516, 40 mg in people with Reflux, run by AstraZeneca at 2 sites in 2 countries.

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 30 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium, Netherlands. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Reflux Episodes 0 to 3 Hours Post Meal (time frame: 0 to 3 hours post meal). 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 NCT01154634.

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 30 Aug 2012.