Pharmacokinetics of Oseltamivir Carboxylate In Morbidly Obese Subjects

NCT01179919 | Completed Phase 1 Results

• 1 other identifier: 10-002
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

Oseltamivir; Obesity; Influenza; Pharmacokinetics in Obesity

Outcome Measures

Primary Outcomes (1)

• Steady-State AUC of Oseltamivir Carboxylate

  AUC is the area under the concentration-time curve. This is measured as concentration in nanograms of oseltamivir carboxylate per milliliter of plasma multiplied by time in hours (hour\*ng/mL)

  6 days

Secondary Outcomes (1)

• Steady-State Cmax and Cmin of Oseltamivir Carboxylate

  6 days

Study Arms (1)

Oseltamivir Dosed Group

EXPERIMENTAL

Oseltamivir 75 mg by mouth every 12 hours for 9 doses

Drug: Oseltamivir

Interventions

Oseltamivir DRUG

Capsule, 75 mg by mouth for 9 doses

Also known as: Tamiflu

Oseltamivir Dosed Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Manjunath Prakash Pai: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

TKL Research

Paramaus, New Jersey, 07652, United States

Location

Related Publications (1)

• Pai MP, Lodise TP Jr. Oseltamivir and oseltamivir carboxylate pharmacokinetics in obese adults: dose modification for weight is not necessary. Antimicrob Agents Chemother. 2011 Dec;55(12):5640-5. doi: 10.1128/AAC.00422-11. Epub 2011 Sep 19.

  PMID: 21930881 DERIVED

MeSH Terms

Conditions

Obesity; Influenza, Human

Interventions

Oseltamivir

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Limitations and Caveats

This study only evaluated obese subjects. The concentrations measured in plasma may not reflect concentrations in tissues such as the lungs.

Results Point of Contact

• Title: Manjunath Pai
• Organization: University of Michigan

amitpai@med.umich.edu

7346473466

Study Officials

• Manjunath Pai, PharmD

  ACPHS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 10, 2010
• First Posted: August 11, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 9, 2017
• Results First Posted: December 6, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)