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Status:

COMPLETED

Safety and Dose Study of Peramivir for Influenza Treatment

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

Influenza

Eligibility:

All Genders

18-50 years

Phase:

PHASE1

Brief Summary

This study will evaluate the safety and tolerability of peramivir, a new drug to treat influenza. The study will administer gradually increasing doses of the drug in successive small groups of subject...

Detailed Description

Human influenza is a serious disease causing over 30,000 deaths in the United States each year, and avian influenza presents a threat of a future pandemic. Despite this burden of current and potential...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • Age greater than or equal to 18 years and less than or equal to 50 years.
  • Weight greater than or equal to 50 kg (110 lbs).
  • Body mass index (BMI) of 19-32 kg/m(2).
  • Subjects must agree to:
  • Not take any prescription or OTC medications with the exception of Tylenol, and contraceptive medications for a period of 7 days prior and during study drug administration.
  • Not consume any alcohol for a period of 2 days prior and during study drug administration.
  • Not receive a live attenuated influenza vaccine (Flumist) for 7 days prior to study drug administration, through day 14 (which will be at least 8 days from the last dose of study drug).
  • Not participate in any other research protocol between screening, and the last day of follow-up.
  • 5\. Females of child-bearing potential must (one of the following):
  • Be surgically sterile.
  • Be abstinent (or willing to be) 4 weeks prior to date of screening evaluation through 4 weeks after study drug administration.
  • Use oral contraceptives, or other form of hormonal birth control including hormonal vaginal rings or transdermal patches, and have been using these for three months prior through 4 weeks after study drug administration.
  • Use an intra-uterine device (IUD) as birth control 4 weeks prior to date of screening evaluation through 4 weeks after study drug administration.
  • Use (by ensuring her male partner(s) uses) barrier contraception (condom) with a spermacide as birth control 4 weeks prior to date of screening evaluation through 4 weeks after study drug administration.
  • EXCLUSION CRITERIA:
  • Any chronic medical problem that requires daily oral medications (except Tylenol and oral contraceptives), or other medical history that in the opinion of the investigator significantly increases the risk associated with a Phase I drug.
  • History of cardiovascular disease or unexplained syncope
  • Family history of sudden death in a first degree relative.
  • Women who are breast-feeding.
  • Positive urine or serum pregnancy test.
  • Abnormal ECG (defined as any baseline Grade 1 or greater toxicity by the toxicity table for ECG. The toxicity table specifically evaluates PR interval, QTc interval and rhythm. Asymptomatic sinus bradycardia, especially in a subject that exercises, is acceptable).
  • Abnormal chemistry panel (defined as any baseline Grade 1 or greater toxicity from the Chem 20 panel evaluating only sodium, potassium, total CO2 (bicarbonate), creatinine, glucose, urea nitrogen, total calcium, total magnesium, phosphorus, alkaline phosphatase, ALT, AST, total bilirubin, direct bilirubin, LDH, total protein, total CK, uric acid).
  • Abnormal complete blood count (CBC) (defined as any baseline Grade 1 or greater toxicity from the CBC evaluating only the WBC, hemoglobin, hematocrit, and platelets).
  • Abnormal urinalysis (defined as any baseline Grade 1 or greater toxicity from the urinalysis evaluating only protein, and RBCs).
  • Positive serology for Hepatitis B surface antigen.
  • Positive serology for Hepatitis C.
  • Positive serology for HIV-1.
  • Positive urine drug screen.
  • Participation in a study of any investigational drug within the last 30 days.

Exclusion

    Key Trial Info

    Start Date :

    February 23 2006

    Trial Type :

    INTERVENTIONAL

    End Date :

    November 14 2006

    Estimated Enrollment :

    100 Patients enrolled

    Trial Details

    Trial ID

    NCT00297050

    Start Date

    February 23 2006

    End Date

    November 14 2006

    Last Update

    July 2 2017

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States, 20892