Phase 2
N=21
Pharmacokinetics of Oseltamivir Carboxylate In Morbidly Obese Subjects
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT01179919 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Steady-State AUC of Oseltamivir Carboxylate — 2579 hour*ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Oseltamivir (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Manjunath Prakash Pai
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Steady-State AUC of Oseltamivir Carboxylate |
2579 | — |
| SECONDARY Steady-State Cmax and Cmin of Oseltamivir Carboxylate |
316; 113 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01179919). 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.