Safety Study of NNZ-2566 in Healthy Subjects, Following Oral Administration
|ClinicalTrials.gov Identifier: NCT01420042|
Recruitment Status : Completed
First Posted : August 19, 2011
Last Update Posted : November 22, 2012
|Condition or disease||Intervention/treatment||Phase|
|Brain Injuries, Traumatic||Drug: NNZ-2566 Drug: Placebo||Phase 1|
Double-blind, placebo-controlled, randomized (with a 6:2 randomization for active versus placebo) safety, dose-escalation, and pharmacokinetic study of NNZ-2566.
Three cohorts will be sequentially dosed, starting with two cohorts receiving a single dose (6mg/kg followed by 30mg/kg). The third cohort will receive two 100mg/kg doses over the course of one day and following a formal safety review the same subjects will then receive two 100mg/kg doses each day for five days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 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 Pharmacokinetics of NNZ-2566 in Healthy Subjects, Following Oral Administration|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||September 2012|
Placebo Comparator: Placebo (lemon flavoured cordial)
NNZ-2566 reconstituted in Lemon flavoured cordial and Water for Injection. 6/8 subjects in each cohort (3 cohorts in total) to receive NNZ-2566 experimental treatment.
Lemon flavoured cordial and Water for Injection
Other Name: Bickford's Bitter Lemon Cordial, 1:1 in Water for Injection
Glycyl-L-2-Methylprolyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials) for reconstitution with lemon flavoured cordial and Water for Injection.
Other Name: NNZ-2566 Lot NNZP25
- Incidence of adverse events (AE) and serious adverse events (SAE) [ Time Frame: Through to Day 7 post end of study drug administration or until resolved ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420042
|Melbourne, Victoria, Australia|
|Principal Investigator:||Maggie Scott||Neuren Pharmaceuticals Ltd|