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

NCT04379869 | Completed Phase 1 DMC

• 1 other identifier: NEU-2591-HV-001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

  25 days

Secondary Outcomes (4)

• Pharmacokinetic - Cmax

  17 days

• Pharmacokinetic - AUC∞

  17 days

• Pharmacokinetic - Tmax

  17 days

• Pharmacokinetic - t1/2

  17 days

Study Arms (4)

NNZ-2591 Single dose Cohort 1

EXPERIMENTAL

Single dose of oral NNZ-2591 in healthy volunteers

Drug: NNZ-2591

NNZ-2591 Single dose Cohort 2

EXPERIMENTAL

Single dose of oral NNZ-2591 in healthy volunteers

Drug: NNZ-2591

NNZ-2591 MAD Cohort 1

EXPERIMENTAL

Multiple Ascending Dose (MAD) of oral NNZ-2591 in healthy volunteers

Drug: NNZ-2591; Drug: Placebo

NNZ-2591 MAD Cohort 2

EXPERIMENTAL

Multiple Ascending Dose (MAD) of oral NNZ-2591 in healthy volunteers

Drug: NNZ-2591; Drug: Placebo

Interventions

NNZ-2591 DRUG

Single dose of NNZ-2591

NNZ-2591 MAD Cohort 1; NNZ-2591 MAD Cohort 2; NNZ-2591 Single dose Cohort 1; NNZ-2591 Single dose Cohort 2

Placebo DRUG

Comparator for double-blind MAD

NNZ-2591 MAD Cohort 1; NNZ-2591 MAD Cohort 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuren Pharmaceuticals Limited: lead

Study Sites (2)

Scientia Clinical Research

Sydney, New South Wales, 2031, Australia

Location

Linear Clinical Research, The Queen Elizabeth II Medical Centre

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Interventions

cyclo-L-glycyl-L-2-allylproline

Study Officials

• James Shaw

  Neuren Pharmaceuticals

  STUDY DIRECTOR

• Jasmine Williams

  Linear Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Stage 1: None Stage 2: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Stage 1: Open-label, single dose with 2 dose cohorts. Stage 2: Randomised, Double-blind, Placebo-controlled, Multiple Ascending Dose (MAD) with 2 dose cohorts

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 8, 2020
• Study Start: May 29, 2020
• Primary Completion: February 11, 2021
• Study Completion: February 11, 2021
• Last Updated: July 9, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)