Healthy VolunteerPhase 1NCT02717754

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

A Phase 1 study testing Oseltamivir in people with Healthy Volunteer, run by Hoffmann-La Roche at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer
What is being tested?: Oseltamivir
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 99 participants
Where: 2 sitesUnited States
Study dates: Dec 2009to May 2010
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Study site
Austin, Texas, 78744
Study site
Little Rock, Arkansas, 72204

Other trials in United States

About this study

Official title: 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.

Conditions: Healthy Volunteer
Being tested: Oseltamivir, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OseltamivirDrug
Also called Tamiflu, RO0640796
Oseltamivir will be administered at 100 or 200 mg intravenous BID for 5 days.
PlaceboDrug
Oseltamivir matched placebo will be administered intravenous for 5 days.

Study groups in NCT02717754
Study group	Role	What they receive
Oseltamivir 100 mg	Experimental	Participants will receive 100 mg oseltamivir intravenous BID for 5 days. Receives: Drug: Oseltamivir
Oseltamivir 200 mg	Experimental	Participants will receive 200 mg oseltamivir intravenous BID for 5 days. Receives: Drug: Oseltamivir
Placebo	Placebo comparator	Participants will receive oseltamivir matched placebo intravenous BID for 5 days. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hour (AUC0-12h) of Oseltamivir and RO0640802 at Steady State
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.
Measured: 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
Cmax is the maximum observed plasma concentration, presented in nanogram per milliliter (ng/mL). RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
Measured: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 5

Secondary outcomes (8)

Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Oseltamivir and RO0640802
AUC is a measure of the plasma concentration of the drug over time. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
Measured: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1
Area Under the Plasma Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUC0-last) of Oseltamivir and RO0640802
AUC is a measure of the plasma concentration of the drug over time. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
Measured: 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
Cmax is the maximum observed plasma concentration. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
Measured: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1
Time to Reach Maximum Plasma Concentration (Tmax) of Oseltamivir and RO0640802
Tmax is time of observed maximum plasma concentration. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
Measured: 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
t1/2 is the time measured for the plasma concentration to decrease by one half. RO0640802 is the pharmacologically active carboxylate metabolite of oseltamivir.
Measured: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5
Volume of Distribution (Vd) of Oseltamivir and RO0640802
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.
Measured: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5
Clearance (CL) of Oseltamivir and RO0640802
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.
Measured: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5
Minimum Plasma Concentration (Cmin) of RO0640802
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.
Measured: 12-hour post dose on Day 1, 5 and predose on Day 2, 3, 4, 5

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009May 2010

First posted24 Mar 2016 (estimated)
Study startDec 2009
Primary completionMay 2010
Study completionMay 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteerStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02717754
Sponsor's protocol ID: NP25140
Status last verified: May 2016
First submitted: 20 Mar 2016
Last updated: 27 Jun 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02717754
Acronym / sponsor ID: NP25140
Conditions: Healthy Volunteer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 24 Mar 2016 (estimated)
Results: Posted 27 Jun 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Oseltamivir 100 mg	Experimental	Drug: OseltamivirParticipants will receive 100 mg oseltamivir intravenous BID for 5 days.
Oseltamivir 200 mg	Experimental	Drug: OseltamivirParticipants will receive 200 mg oseltamivir intravenous BID for 5 days.
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive oseltamivir matched placebo intravenous BID for 5 days.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OseltamivirAlso: Tamiflu, RO0640796Oseltamivir will be administered at 100 or 200 mg intravenous BID for 5 days.	Drug	Oseltamivir 100 mg, Oseltamivir 200 mg
PlaceboOseltamivir matched placebo will be administered intravenous for 5 days.	Drug	Placebo

Primary outcome

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.
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.

8 secondary outcomes

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
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
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
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
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
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
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
Minimum Plasma Concentration (Cmin) of RO0640802
Time frame: 12-hour post dose on Day 1, 5 and predose on Day 2, 3, 4, 5

Results and safety

Results posted to the registry on 27 Jun 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	10	10
Oseltamivir 100 mg	19	19
Oseltamivir 200 mg	20	20
Placebo (Incorrect Infusion Duration)	10	0
Oseltamivir 100 mg (Incorrect Infusion Duration)	20	0
Oseltamivir 200 mg (Incorrect Infusion Duration)	20	0

Primary outcome: 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. Mean (Standard Deviation). Unit: ng*hour/mL

Measure	Oseltamivir 100 mg n = 19	Oseltamivir 200 mg n = 20
Oseltamivir	581 (178)	1143 (178)
RO0640802	4147 (742)	7966 (1427)

Population analysed: Pharmacokinetic (PK) analysis population included all participants who were dosed correctly. Only participants who received oseltamivir were analyzed.

Primary outcome: 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. Mean (Standard Deviation). Unit: ng/mL

Measure	Oseltamivir 100 mg n = 19	Oseltamivir 200 mg n = 20
Oseltamivir	266 (73.1)	496 (69.7)
RO0640802	488 (84.1)	960 (178)

Population analysed: PK analysis population. Only participants who received oseltamivir were analyzed.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 10 days after last dose of study drug (32 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 10 (0%)	7 of 10 (70%)	Not reported
Oseltamivir 100 mg	0 of 19 (0%)	17 of 19 (89.5%)	Not reported
Oseltamivir 200 mg	0 of 20 (0%)	20 of 20 (100%)	Not reported
Placebo (Incorrect Infusion Duration)	0 of 10 (0%)	2 of 10 (20%)	Not reported
Oseltamivir 100 mg (Incorrect Infusion Duration)	0 of 20 (0%)	8 of 20 (40%)	Not reported
Oseltamivir 200 mg (Incorrect Infusion Duration)	0 of 20 (0%)	13 of 20 (65%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study director

Hoffmann-La Roche

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Oseltamivir in people with Healthy Volunteer, run by Hoffmann-La Roche at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02717754.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2016.