Pharmacokinetics of Oseltamivir Carboxylate In Morbidly Obese Subjects

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

One in three Americans are obese. Obese subjects may or may not need higher doses of the anti-flu drug known as Tamiflu (oseltamivir). The current study is being done to see if the FDA approved dose of oseltamivir will achieve similar concentrations in obese healthy volunteers compared to that previously shown in non-obese volunteers.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Manjunath Prakash Pai
• Collaborator: Hoffmann-La Roche
• Treatments: Oseltamivir

Criteria

Inclusion Criteria:

• males and females, 18 to 50 years of age

• non-smoking or light-smoking (≤5 cigarettes per day) volunteers

• BMI ≥ 40 kg/m2

• female subjects of childbearing potential either surgically sterilized, using an effective method of contraception (diaphragm, cervical cap,condom) or agree to abstain from sex from time of pre-study screening, during entire study period and 1 week following the study period.

Exclusion Criteria:

• history of significant hypersensitivity reaction to oseltamivir

• history of gastric bypass surgical procedure

• history of significant clinical illness requiring pharmacological management

• abnormal serum electrolyte or complete blood count requiring further clinical work-up

• transaminases (AST or ALT) >2.5 x upper limit of normal

• estimated creatinine clearance <50 mL/min (Cockcroft-Gault equation)

• positive urine pregnancy test (if female)

• abnormal electrocardiogram (ECG) as judged by study physician

• unable to tolerate venipuncture and multiple blood draws

• clinically significant abnormal physical examination defined as a physical finding requiring further clinical work-up