The effect of time of day, fasting and meal type on biomarkers of liver injury in healthy subjects
- Conditions
- Effect of diet on markers of liver injury in healthy individualsDigestive System
- Registration Number
- ISRCTN15174994
- Lead Sponsor
- Pfizer (United States)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 12
1. Aged 18-55 years old
2. No clinically relevant abnormalities identified by the medical screening
3. Body mass index (BMI) of 17.5-30.5 kg/m²
4. Total body weight >50 kg
5. Smoked =5 cigarettes daily
6. Free from the use of prescription or non-prescription drugs/dietary supplements for at least seven days or five half-lives prior to the first study period
1. Women of childbearing potential
2. History of regular alcohol consumption (>7 drinks/week [female] or >14 drinks/week [male] within six months of screening
3. Treatment with an investigational drug within 30 days or fice half-lives of the first study period
4. Blood pressure =140 mm Hg (systolic) or =90 mm Hg (diastolic) following at least five minutes supine rest
5. Consumption of alcohol, caffeine, and the use of nicotine-containing products were not permitted 24-hours prior to, and during, the resident periods of the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method