None listed
Conditions
Brief summary
To study the pharmacokinetics of DG17 absorption. DG17 is a novel protease inhibitor for the treatment of HIV.
Interventions
Oral 100mg or 200mg of DG17 with 100mg of oral Ritonavir, single dose. Wash-out period is 1 week.
Sponsors
Narhex Life Sciences Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed