- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02717754
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oseltamivir and Its Carboxylate Metabolite, RO0640802 in Healthy Participants
May 18, 2016 updated by: Hoffmann-La Roche
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 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkansas
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Little Rock, Arkansas, United States, 72204
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Texas
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Austin, Texas, United States, 78744
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oseltamivir 100 mg
Participants will receive 100 mg oseltamivir intravenous BID for 5 days.
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Oseltamivir will be administered at 100 or 200 mg intravenous BID for 5 days.
Other Names:
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Experimental: Oseltamivir 200 mg
Participants will receive 200 mg oseltamivir intravenous BID for 5 days.
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Oseltamivir will be administered at 100 or 200 mg intravenous BID for 5 days.
Other Names:
|
Placebo Comparator: Placebo
Participants will receive oseltamivir matched placebo intravenous BID for 5 days.
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Oseltamivir matched placebo will be administered intravenous for 5 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hour (AUC0-12h) of Oseltamivir and RO0640802 at Steady State
Time Frame: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5
|
AUC is a measure of the plasma concentration of the drug over time.
AUC is presented in nanogram times (*) hour per milliliter (ng*hour/mL).
RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
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Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5
|
Maximum Plasma Concentration (Cmax) of Oseltamivir and RO0640802 at Steady State
Time Frame: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5
|
Cmax is the maximum observed plasma concentration, presented in nanogram per milliliter (ng/mL).
RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
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Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Oseltamivir and RO0640802
Time Frame: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1
|
AUC is a measure of the plasma concentration of the drug over time.
RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
|
Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1
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Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Oseltamivir and RO0640802
Time Frame: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5
|
AUC is a measure of the plasma concentration of the drug over time.
RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
|
Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5
|
Cmax of Oseltamivir and RO0640802
Time Frame: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1
|
Cmax is the maximum observed plasma concentration.
RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
|
Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1
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Time to Reach Maximum Plasma Concentration (Tmax) of Oseltamivir and RO0640802
Time Frame: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5
|
Tmax is time of observed maximum plasma concentration.
RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
|
Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5
|
Half-Life (t1/2) of Oseltamivir and RO0640802
Time Frame: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5
|
t1/2 is the time measured for the plasma concentration to decrease by one half.
RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
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Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5
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Volume of Distribution (Vd) of Oseltamivir and RO0640802
Time Frame: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5
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Vd is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
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Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5
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Clearance (CL) of Oseltamivir and RO0640802
Time Frame: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5
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CL is a quantitative measure of the rate at which a drug substance is removed from the body.
RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
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Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5
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Minimum Plasma Concentration (Cmin) of RO0640802
Time Frame: 12-hour post dose on Day 1, 5 and predose on Day 2, 3, 4, 5
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Collection of the 12-hour post-dose sample took place prior to administration of the second daily dose of drug.
RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
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12-hour post dose on Day 1, 5 and predose on Day 2, 3, 4, 5
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
March 20, 2016
First Submitted That Met QC Criteria
March 20, 2016
First Posted (Estimate)
March 24, 2016
Study Record Updates
Last Update Posted (Estimate)
June 27, 2016
Last Update Submitted That Met QC Criteria
May 18, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NP25140
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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