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

NCT ID: NCT02717754

Last Updated: 2016-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2010-05-31

Brief Summary

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.

Conditions

Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Oseltamivir 100 mg

Participants will receive 100 mg oseltamivir intravenous BID for 5 days.

Group Type: EXPERIMENTAL

Oseltamivir

Intervention Type: DRUG

Oseltamivir will be administered at 100 or 200 mg intravenous BID for 5 days.

Oseltamivir 200 mg

Participants will receive 200 mg oseltamivir intravenous BID for 5 days.

Group Type: EXPERIMENTAL

Oseltamivir

Intervention Type: DRUG

Oseltamivir will be administered at 100 or 200 mg intravenous BID for 5 days.

Placebo

Participants will receive oseltamivir matched placebo intravenous BID for 5 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oseltamivir matched placebo will be administered intravenous for 5 days.

Interventions

Oseltamivir

Oseltamivir will be administered at 100 or 200 mg intravenous BID for 5 days.

Intervention Type: DRUG

Placebo

Oseltamivir matched placebo will be administered intravenous for 5 days.

Intervention Type: DRUG

Other Intervention Names

Tamiflu, RO0640796

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Little Rock, Arkansas, United States

Austin, Texas, United States

Countries

United States

Other Identifiers

NP25140

Identifier Type: -

Identifier Source: org_study_id