Safety Study of NNZ-2566 in Healthy Subjects, Following Oral Administration
The purpose of this study is to obtain evidence of safety and determine the pharmacokinetics (PK) of NNZ-2566 in healthy volunteers, when administered orally.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2012|
|Study Completion Date:||September 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
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
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.