A Phase I Single Dose Pharmacokinetic Study of DG17 versus DG17 in combination with ritonavir in Healthy Subjects
- Conditions
- Healthy subjectsOther - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)
- Registration Number
- ACTRN12606000154505
- Lead Sponsor
- arhex Life Sciences Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 18
Able to provide written informed consent· Able to comply with the requirements of the study· Able to provide a permanent residential address· Judged as healthy by medical history, physical examination and laboratory screening within 21 days of study entry· Test negative for HIV, hepatitis B and C· No evidence of drug or alcohol abuse· Willing to abstain from taking any prescription or over-the-counter medication while in the clinical trial – all health supplements were discontinued at least 7 days before the first treatment.
Recent (within the last 12 months) of a serious medical illness or medical disorder· Subject currently taking prescription medications of any type, or non-prescription antacids (alkalis, H2 or proton pump inhibitors)· Current infection· Abnormal findings on physical examination· Abnormal screening laboratory values considered significant by the investigator· Donation of blood within the last 30 days· Participation in another clinical trial within the last 30 days· History of alcohol or drug abuse· Cigarette smokers.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Blood level of DG35 (active drug)[At 0, 15, 30, 45, 60, 90, 120, 150, 180, 240, 360, 480, 600 and 720 min]
- Secondary Outcome Measures
Name Time Method o secondary outcome[]