A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oseltamivir and Its Carboxylate Metabolite, RO0640802 in Healthy Volunteers



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 45
Updated:4/21/2016
Start Date:December 2009
End Date:June 2010

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A Multiple-Center, Randomized, Double-blind, Multiple-Dose, Placebo-Controlled, Parallel-Group Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO0640796 (Oseltamivir) and Its Carboxylate Metabolite, RO0640802, Following Intravenous Administrations in Healthy Subjects

This multi-center, randomized, double-blind, multiple-dose, placebo-controlled,
parallel-group study will assess the safety and PK of oseltamivir (Tamiflu) and its
carboxylate metabolite, RO0640802 in healthy volunteers. Volunteers will be randomized to
receive 100 milligrams (mg) oseltamivir, 200 mg oseltamivir, or placebo, all administered
intravenously twice daily (BID). The anticipated time on study treatment is 5 days.


Inclusion Criteria:

- Volunteers with Body Mass Index (BMI) 18-34 kilograms per meter square (kg/m^2),
inclusive

- Male volunteers who are willing to use barrier contraception for the duration of the
study and for 3 months following the end of treatment

- Female volunteers who are of non-child bearing potential

- Female volunteers who are of child bearing potential utilizing two effective methods
of contraception for the duration of the study and for 3 months following the end of
treatment

Exclusion Criteria:

- Evidence of clinically significant disease or disorder (e.g., renal, cardiac,
bronchopulmonary)

- Any other condition or disease which would place the volunteer at undue risk, or
interfere with the assessment, or with the ability of the volunteer to complete the
study

- Clinically significant orthostatic hypotension present at screening or history of
clinically significant hypotensive episodes or symptoms of fainting, dizziness, or
lightheadedness.

- Volunteers with abnormal electrocardiogram (ECG), bradycardia or mean QTc at
screening

- Positive result for Hepatitis B, Hepatitis C, human immunodeficiency virus (HIV) 1 or
2 at screening

- Renal impairment

- Transplant recipients

- A known clinically relevant history of allergy or hypersensitivity

- Any clinically relevant abnormal laboratory test results

- A clinically relevant history of abuse of alcohol or other drugs of abuse

- Any major illness within 30 days prior to the screening examination

- Smoking of more than 10 cigarettes a day or an equivalent amount of tobacco in the
form of cigars or pipe

- Participation in a clinical study with an investigational drug within 3 months prior
to Day 1

- Donation/loss of more than 500 milliliters (mL) of blood within 3 months prior to Day
1

- Positive pregnancy test at screening or Day -1 and lactating women
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