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The purpose of this study is to investigate the pharmacodynamic effect of AZD2516 in healthy male subjects.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AZD2516, 5 mg | Drug | Capsule, oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reflux Episodes 0 to 3 Hours Post Meal | Total number of reflux episodes 0 to 3 hours post meal | 0 to 3 hours post meal |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 to 3 hours post meal |
| Area Under the Plasma Concentration Curve(AUC) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Berner Hansen | AstraZeneca R&D Molndal | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Leuven | Belgium | ||||
| Research Site |
After enrolment, participant's eligibility for assignment to treatment was based on inclusion and exclusion criteria.
In total 25 participants were enrolled into the study at 2 medical centres (14 and 11 participants), 20 of them were randomised to treatment (10 at each medical centre) and all these 20 participants completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | First 5 mg, Then Placebo, Then 16 mg, Then 40 mg | 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. |
| FG001 | First 40 mg, Then 16 mg, Then Placebo, Then 5 mg | 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. |
| FG002 | First 16 mg, Then 5 mg, Then 40 mg, Then Placebo | 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. |
| FG003 | First Placebo, Then 40 mg, Then 5 mg, Then 16 mg | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 - First Intervention |
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| Period 2 - Washout |
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| Period 3- Second Intervention |
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| Period 4 - Washout |
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| Period 5 - Third Intervention |
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| Period 6 - Washout |
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| Period 7 - Fourth Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | AZD2516 5 mg | Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules. |
| BG001 | AZD2516 16 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reflux Episodes 0 to 3 Hours Post Meal | Total number of reflux episodes 0 to 3 hours post meal | 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. | Posted | Geometric Mean | Full Range | Episodes | 0 to 3 hours post meal |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AZD2516 5 mg | Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disturbance In Attention | Nervous system disorders | MedDRA 10.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | +44 1625 518062 | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| AZD2516, 16 mg | Drug | Capsule, oral |
|
| AZD2516, 40 mg | Drug | Capsule, oral |
|
| Placebo | Drug | Capsule, oral |
|
Area under the plasma concentration vs. time curve from time zero to 12-hours post dose calculated by loglinear trapezoidal method |
| 0 to 12 hours post dose |
| Average Plasma Concentration (C Average) | Average plasma concentration | 1 to 4 hours post dose |
| Maximum Plasma Concentration (Cmax) | Maximum plasma concentration | 0 to 12 hours post dose |
| Time to Maximum Plasma Concentration (Tmax) | Time to maximum plasma concentration (Tmax) | 0 to 12 hours post dose |
| Terminal Half-life (T Half) | Terminal half-life (T half) | 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. | Pre-entry to follow-up |
| Amsterdam |
| Netherlands |
| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
|
Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
| BG002 | AZD2516 40 mg | Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule. |
| BG003 | Placebo | Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG002 | AZD2516 40 mg | Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule. |
| OG003 | Placebo | Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules. |
|
|
| Secondary | 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. | Data from two subjects were excluded from efficacy analysis due to incorrect medication received Data from five visits from two subject were excluded form analysis due to deviations caused by technical problems. | Posted | Geometric Mean | Full Range | relaxations | 0 to 3 hours post meal |
|
|
|
| Secondary | 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 | Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received. | Posted | Geometric Mean | 95% Confidence Interval | nmol*h/L | 0 to 12 hours post dose |
|
|
|
| Secondary | Average Plasma Concentration (C Average) | Average plasma concentration | Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received. | Posted | Geometric Mean | 95% Confidence Interval | nmol/L | 1 to 4 hours post dose |
|
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|
| Secondary | Maximum Plasma Concentration (Cmax) | Maximum plasma concentration | Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received. | Posted | Geometric Mean | 95% Confidence Interval | nmol/L | 0 to 12 hours post dose |
|
|
|
| Secondary | Time to Maximum Plasma Concentration (Tmax) | Time to maximum plasma concentration (Tmax) | Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received. | Posted | Median | Full Range | hours | 0 to 12 hours post dose |
|
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|
| Secondary | Terminal Half-life (T Half) | Terminal half-life (T half) | Data from one subject in arm AZD2516 5 mg were excluded from efficacy analysis due to incorrect medication received. Two samples were not analyzed for T half due to technical reasons. | Posted | Geometric Mean | 95% Confidence Interval | hours | 0 to 12 hours post dose |
|
|
|
| Secondary | Clinically Relevant Change of Laboratory Variables | Number of participants with clinically relevant change of laboratory variables as judged by the responsible medical officer. | Posted | Number | Participants | Pre-entry to follow-up |
|
|
|
| 0 |
| 20 |
| 4 |
| 20 |
| EG001 | AZD2516 16 mg | Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule. | 0 | 20 | 8 | 20 |
| EG002 | AZD2516 40 mg | Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule. | 0 | 20 | 12 | 20 |
| EG003 | Placebo | Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules. | 0 | 20 | 3 | 20 |
| Dizziness | Nervous system disorders | MedDRA 10.0 |
|
| Headache | Nervous system disorders | MedDRA 10.0 |
|
| Balance Disorder | Nervous system disorders | MedDRA 10.0 |
|
| Paraesthesia | Nervous system disorders | MedDRA 10.0 |
|
| Sinus Headache | Nervous system disorders | MedDRA 10.0 |
|
| Somnolence | Nervous system disorders | MedDRA 10.0 |
|
| Flatulence | Gastrointestinal disorders | MedDRA 10.0 |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA 10.0 |
|
| Gastrointestinal Pain | Gastrointestinal disorders | MedDRA 10.0 |
|
| Euphoric Mood | Psychiatric disorders | MedDRA 10.0 |
|
| Daydreaming | Psychiatric disorders | MedDRA 10.0 |
|
| Diplopia | Eye disorders | MedDRA 10.0 |
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| Vision Blurred | Eye disorders | MedDRA 10.0 |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 10.0 |
|
| Pyuria | Renal and urinary disorders | MedDRA 10.0 |
|
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| D004066 | Digestive System Diseases |