Trial · Interventional
CompletedPhase 1Registry dataTo Evaluate the Safety, Tolerability and Pharmacokinetics of Oral NNZ-2591 in Healthy Volunteers
Overview
- Status
- Completed
- Phase
- Phase 1
- Enrollment
- 28 participants (actual)
- Sponsor
- Neuren Pharmaceuticals Limited · Industry
- Design
- Randomized · Quadruple masking
- Countries
1 country
Australia
- Start
- 29 May 2020
- Primary completion
- 11 Feb 2021
- Completion
- 11 Feb 2021
- First posted
- 8 May 2020
- Last update posted
- 9 Jul 2021
- Conditions
- Healthy Volunteers
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
To Evaluate the Safety, Tolerability and Pharmacokinetics of Oral NNZ-2591 in Healthy Volunteers
NCT0437986929 May 2020 to 11 Feb 2021
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of NNZ-2591 when administered to healthy volunteers.
Interventions
- NNZ-2591Drug
- PlaceboDrug
Arms4
Experimental
NNZ-2591 Single dose Cohort 1
Single dose of oral NNZ-2591 in healthy volunteers
Experimental
NNZ-2591 Single dose Cohort 2
Single dose of oral NNZ-2591 in healthy volunteers
Experimental
NNZ-2591 MAD Cohort 1
Multiple Ascending Dose (MAD) of oral NNZ-2591 in healthy volunteers
Experimental
NNZ-2591 MAD Cohort 2
Multiple Ascending Dose (MAD) of oral NNZ-2591 in healthy volunteers
Primary outcomes1
Outcomes the sponsor listed as primary.
Safety and Tolerability measured through Adverse Events /Serious Adverse Events
Time frame · 25 days
Registry description
The frequency and severity of Adverse Events in healthy volunteers administered single and repeated oral doses of NNZ-2591
Secondary outcomes(4)
Pharmacokinetic - Cmax
Time frame · 17 days
Registry description
Maximum observed plasma concentration (Cmax) of NNZ-2591
Pharmacokinetic - AUC∞
Time frame · 17 days
Registry description
Area under the concentration-time curve from time 0 to infinity of NNZ-2591
Pharmacokinetic - Tmax
Time frame · 17 days
Registry description
Time to Cmax of NNZ-2591
Pharmacokinetic - t1/2
Time frame · 17 days
Registry description
Terminal elimination half-life
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 55 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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