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To Evaluate the Safety, Tolerability and Pharmacokinetics of Oral NNZ-2591 in Healthy Volunteers

N

Neuren Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Healthy Volunteers

Treatments

Drug: Placebo
Drug: NNZ-2591

Study type

Interventional

Funder types

Industry

Identifiers

NCT04379869
NEU-2591-HV-001

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of NNZ-2591 when administered to healthy volunteers.

Full 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.

Stage 2: A First-in-Human (FIH), randomised, double-blind, placebo-controlled, Multiple Ascending Dose study (MAD) in healthy volunteers to establish safety, tolerability and pharmacokinetic parameters.

Enrollment

28 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Male or female subjects aged 18 to 55 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.

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

28 participants in 4 patient groups

NNZ-2591 Single dose Cohort 1
Experimental group
Description:
Single dose of oral NNZ-2591 in healthy volunteers
Treatment:
Drug: NNZ-2591
NNZ-2591 Single dose Cohort 2
Experimental group
Description:
Single dose of oral NNZ-2591 in healthy volunteers
Treatment:
Drug: NNZ-2591
NNZ-2591 MAD Cohort 1
Experimental group
Description:
Multiple Ascending Dose (MAD) of oral NNZ-2591 in healthy volunteers
Treatment:
Drug: NNZ-2591
Drug: Placebo
NNZ-2591 MAD Cohort 2
Experimental group
Description:
Multiple Ascending Dose (MAD) of oral NNZ-2591 in healthy volunteers
Treatment:
Drug: NNZ-2591
Drug: Placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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