Status:
COMPLETED
To Evaluate the Safety, Tolerability and Pharmacokinetics of Oral NNZ-2591 in Healthy Volunteers
Lead Sponsor:
Neuren Pharmaceuticals Limited
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of NNZ-2591 when administered to healthy volunteers.
Detailed Description
This study is in two stages: Stage 1: A First-in-Human (FIH), single dose escalation study of oral NNZ-2591 in healthy volunteers to establish safety, tolerability and pharmacokinetic parameters. St...
Eligibility Criteria
Inclusion
- Male or female subjects aged 18 to 55 years, inclusive;
- Weight at screening and admission between 45 kg and 100 kg;
- Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive;
- Healthy as determined by the Investigator based on pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead electrocardiogram (ECG);
- 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;
- 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;
- Negative screen for alcohol and drugs of abuse at screening and admission;
- Non-smokers or ex-smokers (must have ceased smoking \>3 months prior to screening visit);
- If female:
- 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;
- 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;
- Negative serum pregnancy test at screening and negative urine pregnancy test on admission (women of childbearing potential only);
- If male:
- 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.
Exclusion
- 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;
- Fridericia's correction factor for QT (QTcF) \> 450 ms for male participants and \>470ms for female participants or history of QT interval prolongation.
- Have a clinically relevant surgical history, as determined by the Investigator;
- Have a history of relevant atopy or drug hypersensitivity;
- Have a history of alcoholism or drug abuse;
- Consume more than 21 standard drinks a week for males and more than 14 standard drink if female \[1 standard drink is any drink containing 10g of alcohol, regardless of container size or alcohol type\].
- Have a significant infection or known inflammatory process on screening or admission;
- Have acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea, heartburn) at the time of screening or admission;
- 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);
- Have received any investigational drug within 30 days prior to screening;
- Have used tobacco or nicotine products within 3 months of screening
- Have donated or received any blood or blood products within the 3 months prior to screening;
- Cannot communicate reliably with the investigator;
- Are unlikely to co-operate with the requirements of the study;
- Are unwilling or unable to give written informed consent.
- If female:
- Pregnancy or breast-feeding;
- Woman of childbearing potential not willing to use an accepted effective contraceptive method or using hormonal contraceptives;
- If male:
- Not willing to use an accepted effective method of contraception.
Key Trial Info
Start Date :
May 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 11 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04379869
Start Date
May 29 2020
End Date
February 11 2021
Last Update
July 9 2021
Active Locations (2)
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1
Scientia Clinical Research
Sydney, New South Wales, Australia, 2031
2
Linear Clinical Research, The Queen Elizabeth II Medical Centre
Nedlands, Western Australia, Australia, 6009