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Trial record 10 of 118 for:    oseltamivir

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

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ClinicalTrials.gov Identifier: NCT02717754
Recruitment Status : Completed
First Posted : March 24, 2016
Results First Posted : June 27, 2016
Last Update Posted : June 27, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE March 20, 2016
First Posted Date  ICMJE March 24, 2016
Results First Submitted Date  ICMJE May 18, 2016
Results First Posted Date  ICMJE June 27, 2016
Last Update Posted Date June 27, 2016
Study Start Date  ICMJE December 2009
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2016)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 20, 2016)
  • Area Under the Plasma Concentration-Time Curve From Time 0 to 12 Hours (AUC0-12h) of Oseltamivir RO0640802 at Steady State [ Time Frame: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hour post dose on Day 5 of treatment ]
  • 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 hour post dose on Day 5 of treatment ]
Change History Complete list of historical versions of study NCT02717754 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 18, 2016)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 ]
    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.
  • 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 ]
    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.
  • Minimum Plasma Concentration (Cmin) of RO0640802 [ Time Frame: 12-hour post dose on Day 1, 5 and predose on Day 2, 3, 4, 5 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2016)
  • Number of participants with adverse events [ Time Frame: Approximately 2 weeks ]
  • AUC0-12h of Oseltamivir and RO0640802 [ Time Frame: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hour 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 hour post dose on Day 1 and Day 5 and predose (0 hour) on Days 2, 3, 4 ]
  • 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 hour post dose on Day 1 and Day 5 and predose (0 hour) on Days 2, 3, 4 ]
  • 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 hour post dose on Day 1 and Day 5 and predose (0 hour) on Days 2, 3, 4 ]
  • Half-Life (t1/2) of Oseltamivir and ROo640802 [ Time Frame: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hour post dose on Day 1 and Day 5 and predose (0 hour) on Days 2, 3, 4 ]
  • Plasma concentration at 12 hour post dose (C12) of Oseltamivir and RO0640802 [ Time Frame: 12 hours post-dose on Days 1 and 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 hour post dose on Day 1 and Day 5 and predose (0 hour) on Days 2, 3, 4 ]
  • Clearance (CL) of Oseltamivir and RO0640802 [ Time Frame: Predose (0 hour), 1, 2, 3, 3.5, 4, 5, 6, 8, 10, 12 hour post dose on Day 1 and Day 5 and predose (0 hour) on Days 2, 3, 4 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Investigate the Safety, Tolerability, and Pharmacokinetics (PK) of Oseltamivir and Its Carboxylate Metabolite, RO0640802 in Healthy Participants
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Healthy Volunteer
Intervention  ICMJE
  • Drug: Oseltamivir
    Oseltamivir will be administered at 100 or 200 mg intravenous BID for 5 days.
    Other Name: Tamiflu, RO0640796
  • Drug: Placebo
    Oseltamivir matched placebo will be administered intravenous for 5 days.
Study Arms  ICMJE
  • Experimental: Oseltamivir 100 mg
    Participants will receive 100 mg oseltamivir intravenous BID for 5 days.
    Intervention: Drug: Oseltamivir
  • Experimental: Oseltamivir 200 mg
    Participants will receive 200 mg oseltamivir intravenous BID for 5 days.
    Intervention: Drug: Oseltamivir
  • Placebo Comparator: Placebo
    Participants will receive oseltamivir matched placebo intravenous BID for 5 days.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 20, 2016)
99
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02717754
Other Study ID Numbers  ICMJE NP25140
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP