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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Volunteer

In brief

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 participants. Participants 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.

Key facts

Study ID

NCT02717754

Run by

Hoffmann-La Roche

People needed

99

Starts

2009-12-01

Expected to finish

2010-05-01

Last updated by the study team

2016-06-27

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants with Body Mass Index (BMI) 18-34 kilograms per meter square (kg/m\^2), inclusive
• Male participants who are willing to use barrier contraception for the duration of the study and for 3 months following the end of treatment
• Female participants who are of non-child bearing potential
• Female participants 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

You may not qualify if…

• Evidence of clinically significant disease or disorder (for example, renal, cardiac, bronchopulmonary)
• Any other condition or disease which would place the participant at undue risk, or interfere with the assessment, or with the ability of the participant 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.
• Participants 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

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Austin, Texas, United States

Full record on ClinicalTrials.gov

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