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Efficacy, Safety and Tolerability of NP-120 on Idiopathic Pulmonary Fibrosis and Its Associated Cough

Study Purpose

NP-120 (Ifenprodil) has been shown to mediate anti-inflammatory responses and reduce pulmonary fibrosis in a murine model of Idiopathic Pulmonary Fibrosis (IPF). In addition, NP-120 significantly reduced both cough frequency and onset in a guinea pig tussive model. The purpose of this proof-of-concept trial is to determine the efficacy of NP-120 in the treatment of IPF and its associated cough.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A - 85 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male and female subjects with a diagnosis of IPF established during the previous seven years according to ATS/ERS/Fleischner criteria. 2. Score ≥ 40 mm on the Cough Severity VAS at Screening. 3. Lung function parameters as follows: 1. Forced Vital Capacity (FVC) ≥ 45% of the predicted value at screening. 2. Diffusion lung capacity for carbon monoxide (DLCO) (corrected for Hb) of 30% to 79% of the predicted value at screening. 4. Any existing Standard of Care (SoC) treatment (e.g. pirfenidone or nintedanib) must be deemed as stable (minimum three months) before enrollment. 5. Subjects must sign and date a written, informed consent form and any required authorization prior to initiation of any study procedures.

Exclusion Criteria:

1. Currently has significant airways obstruction: Forced Expiratory Volume in 1 s (FEV1)/Forced Vital Capacity (FVC) ratio of < 0.7 at screening. 2. Has clinical evidence of active infection, including, but not limited to, bronchitis, pneumonia, sinusitis, urinary tract infection, and cellulitis. 3. Has a history of malignancy within the last 2 years with the exception of basal cell carcinoma, chronic lymphocytic leukaemia (under observation) and prostate cancer requiring anti-androgens, localised treatment (minor surgery, radiotherapy) and/or managed by observation, and squamous cell carcinoma if diagnosed and successfully treated more than 6 months prior to the study. SCC diagnosed with the past 6 months will be exclusionary. 4. Patients experiencing cerebral hemorrhage or cerebral infarction at screening/baseline. 5. Has any condition other than IPF that, in the opinion of the investigator, is likely to result in the death of the subject within the next 2 years. 6. Presence of other disease that may interfere with testing procedures or in the judgement of the Investigator may interfere with trial participation or may put the patient at risk when participating in this trial. 7. Is likely to receive lung transplantation within the next 12 months. 8. Currently receiving high dose corticosteroid, cytotoxic (e.g., chlorambucil, azathioprine, cyclophosphamide, methotrexate), vasodilator therapy for pulmonary hypertension (e.g., bosentan), and or investigational therapy for idiopathic pulmonary fibrosis (IPF) or administration of such therapeutics within 4 weeks of initial screening (or 5 half-lives, whichever is longer). A current dose of less than or equal to 15 mg/day of prednisone or its equivalent is acceptable if the dose is anticipated to remain stable during the study. 9. Has a history of unstable or deteriorating cardiac or pulmonary disease (other than IPF) within the previous six months, including, but not limited to, the following: 1. Unstable angina pectoris or myocardial infarction, or percutaneous coronary intervention within the last 6 months, 2. Congestive heart failure requiring hospitalization, 3. Uncontrolled clinically significant arrhythmias. 10. If female, the subject is pregnant or lactating or intending to become pregnant before participating in this study during the study and within (5 half- lives plus 30 days) after last dose of the study drug; or intending to donate ova during such time period. 11. Women considered to be of childbearing potential who do not use highly effective birth control methods during the study. 12. Known or suspected allergy to the trial drug or the relevant drugs given in the trial. 13. Involvement in a clinical research study within 4 weeks prior to screening and/or prior enrollment in the study. Participation in registry studies is permitted.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04318704
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Algernon Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, New Zealand
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Arms & Interventions

Arms

Other: Single Arm Active

Ifenprodil

Interventions

Drug: - Ifenprodil

Ifenprodil 20 mg TID

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Vale Medical Practice, Brookvale, New South Wales, Australia

Status

Recruiting

Address

Vale Medical Practice

Brookvale, New South Wales,

Site Contact

Naomi DeFazio

NDeFazio@sonicclinicaltrials.com

61298556000

Concord Repatriation General Hospital, Concord, New South Wales, Australia

Status

Recruiting

Address

Concord Repatriation General Hospital

Concord, New South Wales,

Site Contact

Elizabeth Vietch

elizabeth.veich@health.nsw.gov.au

61297675000

Westmead Hospital, Westmead, New South Wales, Australia

Status

Recruiting

Address

Westmead Hospital

Westmead, New South Wales,

Site Contact

Rita (Perri) Ginn, MSc

rita.ginn@sydney.edu.au

(+612) 8890 7366

Cairns Hospital, Cairns, Queensland, Australia

Status

Recruiting

Address

Cairns Hospital

Cairns, Queensland,

Site Contact

Clinical Research Unit

CairnsCRU@health.qld.gov.au

61742268085

The University of Otago, Christchurch, Canterbury, New Zealand

Status

Recruiting

Address

The University of Otago

Christchurch, Canterbury,

Site Contact

Lutz Beckert

Lutz.Beckert@cdhb.health.nz

0064033640640

Waikato Hospital, Hamilton, Waikato, New Zealand

Status

Recruiting

Address

Waikato Hospital

Hamilton, Waikato,

Site Contact

Catherina Chang

cat.chang@waikatodhb.health.nz

(64) 078398899