Study to Investigate the Pharmacodynamic Effect of a Single Dose of AZD2516 in Healthy Male Subjects
Phase 2
Completed
- Conditions
- Reflux
- Interventions
- Drug: AZD2516, 5 mgDrug: AZD2516, 16 mgDrug: AZD2516, 40 mgDrug: Placebo
- Registration Number
- NCT01154634
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to investigate the pharmacodynamic effect of AZD2516 in healthy male subjects.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 20
Inclusion Criteria
- Provision of signed informed consent
- Healthy male subjects
- Age 18-45 years, inclusive
Exclusion Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description First 5 mg, then placebo, then 16 mg, then 40 mg AZD2516, 5 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. First 5 mg, then placebo, then 16 mg, then 40 mg AZD2516, 16 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. First 5 mg, then placebo, then 16 mg, then 40 mg AZD2516, 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. First 5 mg, then placebo, then 16 mg, then 40 mg Placebo 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 AZD2516, 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. First 40 mg, then 16 mg, then placebo, then 5 mg AZD2516, 16 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. First 40 mg, then 16 mg, then placebo, then 5 mg AZD2516, 40 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. First 16 mg, then 5 mg, then 40 mg, then placebo AZD2516, 40 mg 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 40 mg, then 16 mg, then placebo, then 5 mg Placebo 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 AZD2516, 5 mg 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 16 mg, then 5 mg, then 40 mg, then placebo 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. First placebo, then 40 mg, then 5 mg, then 16 mg AZD2516, 5 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 First placebo, then 40 mg, then 5 mg, then 16 mg AZD2516, 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 First 16 mg, then 5 mg, then 40 mg, then placebo AZD2516, 16 mg 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 Placebo 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 First placebo, then 40 mg, then 5 mg, then 16 mg AZD2516, 40 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
- Primary Outcome Measures
Name Time Method Reflux Episodes 0 to 3 Hours Post Meal 0 to 3 hours post meal Total number of reflux episodes 0 to 3 hours post meal
- Secondary Outcome Measures
Name Time Method Transient Lower Esophagus Sphincter Relaxations (TLESRs) 0 to 3 Hours Post Meal 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.
Area Under the Plasma Concentration Curve(AUC) 0 to 12 hours post dose Area under the plasma concentration vs. time curve from time zero to 12-hours post dose calculated by loglinear trapezoidal method
Average Plasma Concentration (C Average) 1 to 4 hours post dose Average plasma concentration
Maximum Plasma Concentration (Cmax) 0 to 12 hours post dose Maximum plasma concentration
Time to Maximum Plasma Concentration (Tmax) 0 to 12 hours post dose Time to maximum plasma concentration (Tmax)
Terminal Half-life (T Half) 0 to 12 hours post dose Terminal half-life (T half)
Clinically Relevant Change of Laboratory Variables Pre-entry to follow-up Number of participants with clinically relevant change of laboratory variables as judged by the responsible medical officer.
Trial Locations
- Locations (1)
Research Site
🇳🇱Amsterdam, Netherlands