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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04379869




Registration number
NCT04379869
Ethics application status
Date submitted
30/04/2020
Date registered
8/05/2020
Date last updated
29/06/2020

Titles & IDs
Public title
To Evaluate the Safety, Tolerability and Pharmacokinetics of Oral NNZ-2591 in Healthy Volunteers
Scientific title
An Open-label Combined Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of NNZ-2591 in Healthy Volunteers
Secondary ID [1] 0 0
NEU-2591-HV-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NNZ-2591

Experimental: NNZ-2591 SAD Cohort 1 - Single Ascending Dose (SAD) of oral NNZ-2591 in healthy volunteers

Experimental: NNZ-2591 SAD Cohort 2 - Single Ascending Dose (SAD) of oral NNZ-2591 in healthy volunteers

Experimental: NNZ-2591 SAD Cohort 3 - Single Ascending Dose (SAD) 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


Treatment: Drugs: NNZ-2591
Single ascending dose and multiple ascending doses of NNZ-2591

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability measured through Adverse Events /Serious Adverse Events - The frequency and severity of Adverse Events in healthy volunteers administered single and repeated oral doses of NNZ-2591
Timepoint [1] 0 0
25 days
Secondary outcome [1] 0 0
Pharmacokinetic - Cmax - Maximum observed plasma concentration (Cmax) of NNZ-2591
Timepoint [1] 0 0
17 days
Secondary outcome [2] 0 0
Pharmacokinetic - AUC8 - Area under the concentration-time curve from time 0 to infinity of NNZ-2591
Timepoint [2] 0 0
17 days
Secondary outcome [3] 0 0
Pharmacokinetic - Tmax - Time to Cmax of NNZ-2591
Timepoint [3] 0 0
17 days
Secondary outcome [4] 0 0
Pharmacokinetic - t1/2 - Terminal elimination half-life
Timepoint [4] 0 0
17 days

Eligibility
Key inclusion criteria
1. Male or female subjects aged 18 to 65 years, inclusive;

2. Weight at screening and admission between 45 kg and 100 kg;

3. Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive;

4. Healthy as determined by the Investigator based on pre-study medical history, physical
examination, vital signs, complete neurological examination and 12-lead
electrocardiogram (ECG);

5. Negative tests for Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody
(anti-HCV) and human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening;

6. Clinical laboratory test results up to >1.5 x Lower Limit of Normal (LLN) or <1.5 x
Upper Limit of Normal (ULN) at screening and admission and deemed not clinically
significant by the Investigator;

7. Negative screen for alcohol and drugs of abuse at screening and admission;

8. Non-smokers or ex-smokers (must have ceased smoking >3 months prior to screening
visit);

If female:

9. Woman with no childbearing potential by reason of surgery or at least 1year post-
menopause (i.e., 12 months post last menstrual period), and menopause confirmed by
follicle-stimulating hormone (FSH) testing;

10. If of childbearing potential, using an effective nonhormonal method of contraception
(intrauterine device; condom or occlusive cap [diaphragm or cervical or vault caps];
true abstinence; or vasectomized male partner (provided that he is the sole partner of
that subject and had a vasectomy =30 days prior to screening) for the duration of the
study and up to one month after the last investigational medicinal product (IMP)
administration;

11. Negative serum pregnancy test at screening and negative urine pregnancy test on
admission (women of childbearing potential only);

If male:

12. Using an effective method of contraception (condom) if sexually active with a female
partner of child-bearing potential; true abstinence; or vasectomy =30 days prior to
screening) throughout the study and for one month after the last IMP administration.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Subjects who have a clinically relevant history as determined by the Investigator, or
presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic,
neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary,
immunological, dermatological, endocrine, connective tissue diseases or disorders;

2. Fridericia's correction factor for QT (QTcF) > 450 ms for male participants and >470ms
for female participants or history of QT interval prolongation.

3. Have a clinically relevant surgical history, as determined by the Investigator;

4. Have a history of relevant atopy or drug hypersensitivity;

5. Have a history of alcoholism or drug abuse;

6. Consume more than 21 standard drinks a week for males and more than 14 standard drink
if female [1 standard drink is any drink containing 10g of alcohol, regardless of
container size or alcohol type].

7. Have a significant infection or known inflammatory process on screening or admission;

8. Have acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, heartburn) at
the time of screening or admission;

9. Have used any prescription or non-prescription medicines within 2 weeks of admission,
unless in the investigator's opinion will not affect determination of safety or other
study assessments. Occasional paracetamol use (up to 2g/day is permitted);

10. Have received any investigational drug within 30 days prior to screening;

11. Have used tobacco or nicotine products within 3 months of screening

12. Have donated or received any blood or blood products within the 3 months prior to
screening;

13. Cannot communicate reliably with the investigator;

14. Are unlikely to co-operate with the requirements of the study;

15. Are unwilling or unable to give written informed consent.

If female:

16. Pregnancy or breast-feeding;

17. Woman of childbearing potential not willing to use an accepted effective contraceptive
method or using hormonal contraceptives;

If male:

18. Not willing to use an accepted effective method of contraception.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Linear Clinical Research, The Queen Elizabeth II Medical Centre - Nedlands
Recruitment postcode(s) [1] 0 0
6009 - Nedlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Neuren Pharmaceuticals Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of
NNZ-2591 when administered to healthy volunteers.
Trial website
https://clinicaltrials.gov/show/NCT04379869
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
James Shaw
Address 0 0
Neuren Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Nicola Norton
Address 0 0
Country 0 0
Phone 0 0
+61 (0) 414 416 034
Fax 0 0
Email 0 0
nnorton@linear.org.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04379869