A DDI Study to Evaluate the Effects of Itraconazole and Fluoxetine on AK0529 in Healthy Volunteers
- Conditions
- Respiratory Syncytial Virus InfectionInfection - Other infectious diseases
- Registration Number
- ACTRN12619001413112
- Lead Sponsor
- Ark Biosciences Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 28
1.Completion of the written informed consent process.
2.Male or female subjects aged 18 to 55 years of age, with a body mass index (BMI) within the range of 18 to 30 kg/m2 (inclusive).
3.Subjects not pregant, or will not be pregant, and agreed to use effective contraception method(s) during the study per protocol requirement.
4.Good health based on no clinically significant findings in the medical history, physical examination, or clinical laboratory test results.
5.Willing and able to comply with all study activities and procedures.
1.Has a QTcF interval > 450 msec.
2.Has a history or presence of prolonged QTc or family history of long QT syndrome.
3.Has any finding that, in the opinion of the investigator, would compromise the subject’s ability to fulfill the protocol visit schedule or study requirements.
4.Has current evidence, or history of any clinically significant medical or psychiatric condition or observed abnormality that could potentially compromise subject safety or evaluation of PK parameters.
5.If female, is currently pregnant or breastfeeding.
6.Has a history of, or current infection with, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus, or has a history of liver disease, including unexplained fluctuations in liver function tests.
7.Has used CYP3A4 or CYP2D6 inhibitors or inducers or P-gp inhibitors within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, or anticipates a need to use any CYP3A4 or CYP2D6 inhibitors or inducers, or P-gp inhibitors during the study period.
8.Use of prescription or non-prescription drugs, herbal products, nutritional supplements or ‘alternative’ medication or remedies within 14 days or 5 half-lives (whichever is the longer) prior to the first dose of study drug.
9.Intake of grapefruit, grapefruit juice or grapefruit-related citrus fruits within 7 days prior to the first dose of the study medication.
10.Has a known intolerance or allergy to AK0529, itraconazole, fluoxetine or related compounds.
11.Previous intolerance to SSRI or SNRI drugs.
12.Has a history or current presence of psychiatric symptoms including anxiety, mood disturbance, suicidal ideation or self-harming behaviour.
13.Has a history of seizure, except for simple, febrile convulsion as a child.
14.History of regular alcohol consumption exceeding a weekly intake of more than 21 units for males and more than 14 units for females within 6 months of screening.
15.Is a smoker, or has ceased using tobacco-containing or nicotine-containing products within 3 months of screening, not including light or social smoking not exceeding the equivalent of 5 cigarettes per week, and/or has a positive cotinine test at screening or Day -1.
16.Excessive consumption of beverages containing xanthine bases.
17.Has used alcohol-, caffeine- or xanthine-containing products within 72 hours prior to admission on Day -1.
18.Has a positive urine toxicological screen for cotinine (or saliva test), benzodiazepines, opioids amphetamine/methamphetamine, cannabinoids or cocaine at screening or Day -1.
19.Has a positive alcohol breath test at screening or Day -1.
20.Has donated blood of more than 500 ml within 4 weeks prior to screening.
21.Participation in any investigational product study within 12 weeks or five half-lives (whichever is longer) prior to the first dose of the study medication.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method