Phase 2
Completed N=20
Study to Investigate the Pharmacodynamic Effect of a Single Dose of AZD2516 in Healthy Male Subjects
Reflux
Source: ClinicalTrials.gov NCT01154634 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcomePrimary: Reflux Episodes 0 to 3 Hours Post Meal — 15.1; 12.5; 11.0; 12.7 Episodes
Summary
The purpose of this study is to investigate the pharmacodynamic effect of AZD2516 in healthy male subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reflux Episodes 0 to 3 Hours Post Meal |
15.1; 12.5; 11.0; 12.7 | — |
| SECONDARY Transient Lower Esophagus Sphincter Relaxations (TLESRs) 0 to 3 Hours Post Meal |
16.9; 16.2; 10.4; 16.8 | — |
| SECONDARY Area Under the Plasma Concentration Curve(AUC) |
251.5; 906.6; 2825 | — |
| SECONDARY Average Plasma Concentration (C Average) |
45.46; 175.8; 506.8 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) |
103.8; 378.0; 911.7 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) |
0.750; 0.750; 1.000 | — |
| SECONDARY Terminal Half-life (T Half) |
1.221; 1.416; 1.584 | — |
| SECONDARY Clinically Relevant Change of Laboratory Variables |
0; 0; 0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01154634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.