NCT02717754

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
3 months until next milestone

Results Posted

Study results publicly available

June 27, 2016

Completed
Last Updated

June 27, 2016

Status Verified

May 1, 2016

Enrollment Period

5 months

First QC Date

March 20, 2016

Results QC Date

May 18, 2016

Last Update Submit

May 18, 2016

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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

    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

    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

    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

    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

    Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hours post dose on Day 1 and Day 5

  • +3 more secondary outcomes

Study Arms (3)

Oseltamivir 100 mg

EXPERIMENTAL

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

Drug: Oseltamivir

Oseltamivir 200 mg

EXPERIMENTAL

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

Drug: Oseltamivir

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

OseltamivirDRUG

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

Also known as: Tamiflu, RO0640796
Oseltamivir 100 mgOseltamivir 200 mg
PlaceboDRUG

Oseltamivir matched placebo will be administered intravenous for 5 days.

Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Unknown Facility

Little Rock, Arkansas, 72204, United States

Location

Unknown Facility

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

Oseltamivir

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsCyclohexenesCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbons

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-LaRoche
genentech@druginfo.com
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2016

First Posted

March 24, 2016

Study Start

December 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

June 27, 2016

Results First Posted

June 27, 2016

Record last verified: 2016-05

Locations

US(2)