Safety and Tolerability Study of N6022 in Healthy Subjects
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|ClinicalTrials.gov Identifier: NCT01147406|
Recruitment Status : Completed
First Posted : June 22, 2010
Results First Posted : March 7, 2014
Last Update Posted : March 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: N6022 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effect of N6022 in Healthy Subjects|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
This is an injectible formulation which will be given at 5, 15 & 45 mg over 1, 3 and 9 minutes respectively, in single ascending doses.
Placebo Comparator: Placebo
This will be 0.9% normal saline given over 1, 3, or 9 minutes IV bolus.
Other Name: N6022
- Safety and Tolerability of a Single Ascending Doses of Intravenous N6022 in Healthy Volunteers [ Time Frame: 7 Days ]Safety variables - number of adverse events reported during study, changes in vital signs, physical examination findings, telemetry alerts, 12-lead ECG changes, infusion site reactions, O2 saturation changes, and clinical laboratory assessment changes between subjects receiving N6022 versus placebo.
- Maximum N6022 and Metabolite Concentrations in Plasma Within 24 Hours of End of Administration [ Time Frame: 24 hours ]Concentrations of N6022 and metabolite [N61149)], collected on Days 1 and 7; predose, end of infusion, and at 10 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 16, and 24 hours post-dose (the 24 hour postdose collected prior to the start of infusion on Day 2).
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): NCT01147406
|United States, Maryland|
|Parexel Early Phase Unit|
|Baltimore, Maryland, United States, 21225|
|Principal Investigator:||Ronald Goldwater, MDCM, MSc(A)||Parexel|