Last updated: 05/17/2019 08:22:02
An Open-Label, Non-Randomized, Single-Dose Study To Evaluate Serum Zanamivir Pharmacokinetics Following Intravenous Administration to Human Subjects With Renal Impairment Compared to Subjects Without Renal Impairment.
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An Open-Label, Non-Randomized, Single-Dose Study To Evaluate Serum Zanamivir Pharmacokinetics Following Intravenous Administration to Human Subjects With Renal Impairment Compared to Subjects Without Renal Impairment.
Trial description: An Open-Label, Non-Randomized, Single-Dose Study To Evaluate Serum Zanamivir Pharmacokinetics Following Intravenous Administration to Human Subjects With Renal Impairment Compared to Subjects Without Renal Impairment.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2007-16-04
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Stephen Weller, Lori S Jones, Yu Lou, Amanda Peppercorn, Judith Ng-Cashin. Pharmacokinetics of zanamivir following intravenous administration to subjects with and without renal impairment. Antimicrob Agents Chemother. 2013;
Medical condition
Influenza, Human
Product
zanamivir
Collaborators
Not applicable
Study date(s)
September 2006 to April 2007
Type
Interventional
Phase
1
Participation criteria
Sex
Not applicable
Age
Not applicable
Accepts healthy volunteers
Not applicable
Inclusion and exclusion criteria
Trial location(s)
Location
GSK Investigational Site
Knoxville, Tennessee, United States, 37920
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Minneapolis, Minnesota, United States, 55404
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Orlando, Florida, United States, 32809
Status
Terminated/Withdrawn
Study documents
Scientific result summary
Available language(s): English
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2007-16-04
Actual study completion date
2007-16-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website