Pharmacokinetics of IV Formulation
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|ClinicalTrials.gov Identifier: NCT03076905|
Recruitment Status : Withdrawn (study no longer required in current format)
First Posted : March 10, 2017
Last Update Posted : November 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Invasive Aspergillosis||Drug: F901318||Phase 1|
Open label single intravenous dose, single group study. Eight subjects (ideally 4 male and 4 female, minimum of two females) will be studied. The drug product will be a F901318 solution for infusion (6mg/mL). The dose will be 4 mg/kg delivered in the fasted state (8 hours minimum) by intravenous infusion over 2 hours. Each subject will be on study for approximately 6 weeks. Each subject will reside at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 4 (72 hours post-dose). Blood samples for pharmacokinetic evaluation will be obtained up to and including 120 hours post dose. Safety and tolerability will also be assessed.
Subjects will return to the clinical unit at 96 and 120 hours for pharmacokinetic blood sampling.
All subjects will return for a post-study visit 8 to 10 days after the dose of study medication.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Assessment of IV pharmacokinetics|
|Masking:||None (Open Label)|
|Official Title:||F901318 - A Phase I, Single Intravenous Dose, Safety, Tolerability and Pharmacokinetics Study in Healthy Male and Female Subjects|
|Estimated Study Start Date :||May 2017|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||August 2017|
Experimental: IV drug
AUC0-t of single intravenous dose of F901318
Evaluation of AUC0-t
- Pharmacokinetic profile (AUC0-t) [ Time Frame: 120 hours ]AUC0-t
- Tolerability (Adverse events) [ Time Frame: 120 hours ]Adverse events
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): NCT03076905
|Principal Investigator:||Litza McKenzie, MD||Quotient Clinical|