A phase I, open-label, randomized, three-way cross-over study to determine the relative bioavailability of an oral capsule formulation, given both in the fasted state and after a high fat meal, compared to an oral suspension of PSN821 in healthy male volunteers.
Completed
- Conditions
- Diabetes Type II10018424
- Registration Number
- NL-OMON34811
- Lead Sponsor
- OSI Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
Inclusion Criteria
* healthy male
* between 18 * 55 years of age
* BMI is between 18 * 25 kg/m2
* at screening the state of health must satisfy the entry requirements
Exclusion Criteria
* suffering from severe illness such as hepatitis B, hepatitis C or HIV
* taken part in more than 3 other drug studies in the 10 months prior to the start of this study
* donated blood within the 60 days prior to the start of this study (50 mL or more)
* donated more than 1.5 liters during the 10 months prior to the start of this study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetics:<br /><br>Concentrations of PSN821 and its metabolite PSN715297 in plasma will be<br /><br>determined; PK parameters of PSN821 and metabolite PSN715297 will be calculated.<br /><br><br /><br>Safety:<br /><br>Safety will be monitored by AEs, clinical laboratory (haematology, chemistry<br /><br>and urinalysis), vital signs (supine and standing systolic and diastolic blood<br /><br>pressure, pulse rate) and ECG.</p><br>
- Secondary Outcome Measures
Name Time Method <p>n/a</p><br>