Safety Study of NNZ-2566 in Healthy Female Subjects
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|ClinicalTrials.gov Identifier: NCT00961779|
Recruitment Status : Completed
First Posted : August 19, 2009
Last Update Posted : October 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Brain Injuries, Traumatic||Drug: NNZ-2566 Drug: Placebo||Phase 1|
To obtain evidence of the safety of NNZ-2566 in healthy female volunteers, compared to placebo when administered as a 10 minute intravenous (i.v.) bolus infusion, and when administered as a 10-minute bolus infusion immediately followed by a continuous 72-hour maintenance infusion.
To determine the blood pharmacokinetics (PK) of an intravenous dose of NNZ-2566 in healthy female volunteers when administered as a 10-minute bolus infusion, and when administered as a 10-minute bolus followed by a continuous 72-hour maintenance infusion.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase I, Double-Blind, Randomized, Dose Escalation Study to Assess the Safety, Tolerability and PK of NNZ-2566 in Healthy Females, When Administered as a Loading Dose (10-Min), and as a Loading Dose Followed by a Maintenance Dose (72-Hr).|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||September 2010|
|Placebo Comparator: Placebo (Normal saline infusion)||
Normal saline infusion
Other Name: Sodium Chloride 0.9% Injection
NNZ-2566 reconstituted in bicarbonate buffer and normal saline. 6/8 subjects in each cohort (5 cohort in total) to receive NNZ-2566 experimental treatment.
Glycyl-L-2-Methylprolyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials) for reconstitution with bicarbonate buffer and normal saline.
Other Name: Experimental name: NNZ-2566
- Incidence of AEs and SAEs [ Time Frame: Through to Day 7 post end of study drug infusion or until resolved ]
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): NCT00961779
|Melbourne, Victoria, Australia, 3004|
|Study Director:||Douglas J Wilson, MB ChB, PhD||Neuren Pharmaceuticals Ltd|