Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: Oseltamivir Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
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
Study Start Date : December 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Oseltamivir

Arm Intervention/treatment
Experimental: Oseltamivir 100 mg
Participants will receive 100 mg oseltamivir intravenous BID for 5 days.
Drug: Oseltamivir
Oseltamivir will be administered at 100 or 200 mg intravenous BID for 5 days.
Other Name: Tamiflu, RO0640796

Experimental: Oseltamivir 200 mg
Participants will receive 200 mg oseltamivir intravenous BID for 5 days.
Drug: Oseltamivir
Oseltamivir will be administered at 100 or 200 mg intravenous BID for 5 days.
Other Name: Tamiflu, RO0640796

Placebo Comparator: Placebo
Participants will receive oseltamivir matched placebo intravenous BID for 5 days.
Drug: Placebo
Oseltamivir matched placebo will be administered intravenous for 5 days.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  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.

  6. 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.

  7. 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.

  8. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717754


Locations
Layout table for location information
United States, Arkansas
Little Rock, Arkansas, United States, 72204
United States, Texas
Austin, Texas, United States, 78744
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Layout table for investigator information
Study Director: Clinical Trials Hoffmann-La Roche

Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02717754     History of Changes
Other Study ID Numbers: NP25140
First Posted: March 24, 2016    Key Record Dates
Results First Posted: June 27, 2016
Last Update Posted: June 27, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
Layout table for MeSH terms
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action