Clinical Trial of Intranasal Delivery of NT-301 (NCT06954428) | Clinical Trial Compass
CompletedPhase 1
Clinical Trial of Intranasal Delivery of NT-301
Australia49 participantsStarted 2025-06-20
Plain-language summary
The purpose of this research project is to investigate the safety and tolerability of an approved drug (Apomorphine) when administered as a nasal powder spray formulation (NT-301) as well as collect information on how NT-301 moves into, through and out of your body, called Pharmacokinetics. The study also aims to compare the safety, tolerability and pharmacokinetics of NT-301 to an injectable Apomorphine product (Movapo Pen), already approved for use in Australia.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Male or female participants aged between 18 and 60 years of age, inclusive at the time of signing the informed consent document.
✓. Body weight ≥50 kg and body mass index (BMI) within the range of 18 to 32 kg/m2 inclusive at screening.
✓. Woman of childbearing potential (WOCBP) or fertile male participants must agree to use an acceptable method of contraception from the start of Screening until 90 days (male participants) or 60 days (female participants) after the final study visit.
✓. WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to administration of the first dose of study intervention (including domperidone) and be willing to have additional pregnancy tests, as required, throughout the study.
✓. Participants must be in good general health, as demonstrated at screening and prior to first administration of any study intervention (including domperidone) by the absence of clinically significant (in the opinion of the Investigator) abnormalities based on a medical evaluation including review of medical history, physical examination, safety laboratory tests, vital signs, 12-lead ECG monitoring.
✓. Normal vital signs after ≥5 min resting in supine position:
✓. ≥90 mmHg and ≤160 mmHg systolic blood pressure (SBP)
✓. ≥50 mmHg and ≤95 mmHg diastolic blood pressure (DBP)
Exclusion criteria
✕. Any significant medical condition, physical or psychiatric illness or history of depression that could, in the Investigator's (or qualified designee) opinion, compromise the participant's safety or interfere with the completion of this study.
✕. History of clinically significant CNS, cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions including gastric bypass or other weight loss surgical procedure.
✕. Any condition including the presence of laboratory abnormalities, which according to the Investigator (or qualified designee), places the participant at unacceptable risk if they were to participate in the study or may confound the ability to interpret data from the study. This includes the presence of uncontrolled current illness (e.g., an infection), a viral infection, seasonal allergy, or concurrent skin rash.
✕. Any nasal condition, including nasal congestion, physical blockage of either nostril, deviated septum, structural or anatomical nasal conditions or nasal surgery in the last 6 months. Use of topical nasal medications (e.g., acute or chronic use of prescription or over the counter nasal sprays) that may affect the administration or absorption of the study drug.
✕. Use of 5HT3 antagonists, drugs known to prolong QTc, and use of antihypertensives.
✕. The participant has a medical history of or a positive blood test for human immunodeficiency virus (HIV: HIV, anti-HIV1 and anti-HIV2 antibodies), hepatitis C virus (HCV, anti-HCV antibodies), or hepatitis B surface antigen (HBsAg) at screening.
✕. Aspartate transaminase (AST), alanine transaminase (ALT), gamma-glutamyl transferase (GGT), serum creatine, or total bilirubin \>1.5x the upper limit of normal (ULN). These laboratory tests may be repeated once if they are abnormal on first screening, and if there is a medical reason to believe the results may be inaccurate. If the repeat test is within the normal range, the participant may be included in the study only if the Investigator (or qualified designee) considers that the previous finding will not compromise the participant's safety and will not interfere with the interpretation of safety data.
✕. A positive drug or alcohol screen. A positive drug or alcohol screen test result may be verified by re-testing at the discretion of the Investigator (or qualified designee), with up to 1 false positive result permitted.