Ignite Creation Date:
2024-05-06 @ 3:00 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02178254
Status:
COMPLETED
Last Update Posted:
2016-04-04
First Post:
2014-06-26
Brief Title:
Safety Tolerability and PK 3-Period Crossover Study Comparing 2 Single Doses of ZTI-01 and Monurol in Healthy Subjects
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
A Randomized Safety Tolerability and Pharmacokinetics 3-Period Crossover Study Comparing 2 Single Doses of ZTI-01 and Monurol in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2015-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective is to determine the safety tolerability and pharmacokinetics PK of 2 single doses of ZTI-01 1g and 8g infused over 1-hr and a single dose of the Reference Label Drug Monurol oral sachet 3g Subjects will be randomized to a treatment sequence prior to dosing on Day 1 of Period 1 prior to study screening
Detailed Description:
This is a Phase 1 single-dose randomized 3-Period crossover study conducted at a single center A total of 30 healthy subjects aged 18-45years will be randomized to receive one of 3 treatment sequences The duration of study will be approximately 18-26 days and subject participation will be the duration of study Each treatment sequence will be enrolled in parallel and each subject will receive all 3 treatments in crossover fashion Each subject will complete Screening Baseline and Treatment Phases The Screening Phase will be conducted on an outpatient basis within 35 days of admission Day -1 of Period 1 All subjects admitted to the study center the day before dosing in each treatment period Day -1 check-in for pre-dosing assessments and will remain in the study center through 48 hours post-dose for each Period Final baseline qualification will only be evaluated prior to randomization for Treatment Period 1 Each one of the periods will be separated by a 3 minimum to 7 days maximum washout period The Treatment Phase will be comprised of 3 crossover periods duration Day-1 to 48 hours post dose Each crossover period will include a single dose of study drug under fasting conditions followed by post-dose safety assessments and blood and urine collection for PK measures through 48 hours post-dose each period will be separated by a 3 to 7 days washout Subjects will remain in the study center for all 3- study treatment periods Day -1 to 48 hours post dosing and will be discharged after the 48-hour sampling timepoint if safety parameters are acceptable to the Investigator on Day 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HHSN272201500005I | None | None | None |