A Phase 1 Study of the Pharmacokinetics and Safety of IRX211 in Healthy Volunteers
- Conditions
- Complex Regional Pain SyndromeNeurological - Other neurological disorders
- Registration Number
- ACTRN12623000465651
- Lead Sponsor
- InhaleRx Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 28
Each participant must meet all the following criteria to be enrolled in this study:
1. Aged between 18 and 55 years (inclusive at Day 1).
2. Free from clinically significant (in the opinion of the Investigator) illness or disease as determined by their medical and surgical history, physical examination, 12-lead ECG, vital signs and clinical laboratory determinations.
3. BMI between 18 and 32 kg/m2 (inclusive) at Screening.
4. Weight greater or equal to 50.0 kg at Screening.
5. Adequate venous access in both arms for collection of a number of blood samples.
6. Capable of understanding the purposes and risks of the study and able to provide written informed consent before any study-specific screening procedures are performed.
7. Willing and able to adhere to all protocol requirements, including willingness to comply with scheduled visits, and tolerance to dosing using an inhaler.
8. The subject is able to perform deep inhalations with FEV1 more than 80%.
9. Female subjects of childbearing potential must be abstinent from heterosexual intercourse or agree to use an acceptable form of contraception with a male sexual partner and agrees to refrain from egg donation.
10. Male subjects must be abstinent from heterosexual intercourse or agree to use an acceptable form of contraception with a female sexual partner of childbearing potential and agrees to refrain from sperm donation.
Participants who meet any of the following criteria will be excluded from this study:
1.History of coronary disease, peripheral vascular disease, cerebrovascular accident, transient ischemic attack, uncontrolled hypertension or signs/symptoms of ischemic heart disease.
2.History of acute or severe bronchial asthma (excluding childhood or exercise induced asthma), diagnosed obstructive sleep apnea, hypoxia, hypoxemia, hypercarbia, or other obstructive airway disease or any condition that may increase the risk for respiratory depression.
3.History of neurologic conditions such as seizures (excluding single febrile seizures during childhood) or convulsive disorders (including epilepsy), severe head injury or increased intracranial pressure.
4.Any concussion (within 5 weeks from Day 1), or prior concussion where there are ongoing symptoms.
5.Presence of current psychiatric condition or psychiatric condition requiring pharmacological management within the last 6 months, presence of current or history of psychosis/schizophrenia and bipolar disorders.
6.A calculated creatinine clearance of less than 80 mL/minute at Screening or Check-In (Day -1) according to the equation using Cockcroft and Gault.
7.Liver function tests showing values for alanine transaminase (ALT) or aspartate transaminase (AST) greater than 1.5 times the upper limit of normal (ULN) at Screening.
8.Evidence or history of clinically relevant (in the opinion of the Investigator) other cardiovascular, pulmonary, neurologic or renal disorders or hepatic, gastrointestinal, oral (difficulty swallowing / taking oral medication), hematological, endocrine, or psychiatric impairment/disorders, making implementation of the protocol or interpretation of the study results difficult, or that would put the subject at risk by participating in the study in the opinion of the Investigator.
9.Have undergone surgery requiring or have received (for any reason) anesthetic within 30 days of Day 1.
10.Use of central nervous system (CNS) depressants including opioids, sedatives, anxiolytics, hypnotics, neuroleptics, phenothiazines, tranquilizers, skeletal muscle relaxants, sedating antihistamines or cimetidine within 30 days of Day 1.
11.Use of macrolide antibiotics (e.g., Erythromycin), azole antifungal agents (e.g., Ketoconazole) or protease inhibitors (e.g., Ritonavir) within 30 days of Day 1.
12.Use of any prescription medication within 14 days of Day 1 and for duration of study, unless approved by both the Investigator and the Medical Monitor (in writing). COVID-19 vaccine within 1 week of Day 1 may be administered. Paracetamol ibuprofen, hormonal contraception may be administered.
13.Use of any over the counter product, herbal product, diet aid, or hormone supplement, with a particular regard to hemp or products containing cannabidiol, within 14 days of Day 1 and for duration of study, unless approved by both the Investigator and Medical Monitor (in writing). Vitamins and dietary supplements and topical preparations may be administered (other than those in the prohibited list).
14.History of severe allergic or anaphylactic reactions, known intolerance, allergy or hypersensitivity reactions to dronabinol.
15.Positive screening test for Human Immunodeficiency Virus (HIV) antibodies, Hepatitis B surface antigen or Hepatitis C antibody.
16.Evidence or history of substance or alcohol abuse (drink more than 4 standard units of alcohol per day or greater
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method