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Trial registered on ANZCTR


Trial ID
ACTRN12606000154505
Ethics application status
Approved
Date submitted
3/05/2006
Date registered
3/05/2006
Date last updated
3/05/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Phase I Single Dose Pharmacokinetic Study of DG17 versus DG17 in combination with ritonavir in Healthy Subjects
Scientific title
A Phase I Single Dose Pharmacokinetic Study of DG17 versus DG17 in combination with Ritonavir in healthy subjects
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy subjects 1128 0
Condition category
Condition code
Other 1206 1206 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral 100mg or 200mg of DG17 with 100mg of oral Ritonavir, single dose. Wash-out period is 1 week.
Intervention code [1] 809 0
Treatment: Drugs
Comparator / control treatment
Oral 100mg or 200mg of DG17 without 100mg of oral Ritonavir, single dose.
Control group
Active

Outcomes
Primary outcome [1] 1635 0
Blood level of DG35 (active drug)
Timepoint [1] 1635 0
At 0, 15, 30, 45, 60, 90, 120, 150, 180, 240, 360, 480, 600 and 720 min
Secondary outcome [1] 2932 0
No secondary outcome
Timepoint [1] 2932 0

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
45 Years
Gender
Males
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1318 0
Commercial sector/Industry
Name [1] 1318 0
Narhex Life Sciences Ltd
Address [1] 1318 0
Country [1] 1318 0
Australia
Funding source category [2] 1319 0
Hospital
Name [2] 1319 0
Alfred Hospital Melbourne
Address [2] 1319 0
Country [2] 1319 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Narhex Life Sciences Ltd.
Address
Country
Australia
Secondary sponsor category [1] 1164 0
None
Name [1] 1164 0
Nil
Address [1] 1164 0
Country [1] 1164 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2645 0
Alfred Hospital (Melbourne)
Ethics committee address [1] 2645 0
Ethics committee country [1] 2645 0
Australia
Date submitted for ethics approval [1] 2645 0
Approval date [1] 2645 0
22/12/2005
Ethics approval number [1] 2645 0
228/05

Summary
Brief summary
To study the pharmacokinetics of DG17 absorption. DG17 is a novel protease inhibitor for the treatment of HIV.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35635 0
Address 35635 0
Country 35635 0
Phone 35635 0
Fax 35635 0
Email 35635 0
Contact person for public queries
Name 9998 0
Prof. John Mills
Address 9998 0
Alfred Hospital
Faculty of Medicine, Nursing and Health Sciences
Commercial Rd., Melbourne, VIC 3004
Country 9998 0
Australia
Phone 9998 0
+61 3 99030677
Fax 9998 0
+61 3 95212124
Email 9998 0
mills@portsea.net
Contact person for scientific queries
Name 926 0
Prof. Henry Krum
Address 926 0
NHMRC Centre of Clinical Research Excellence in Therapeutics
Faculty of Medicine, Nursing and Health Sciences
3rd floor, Burnet tower, AMREP Precinct
89 Commercial Rd., Melbourne VIC 3004
Country 926 0
Australia
Phone 926 0
+61 3 99030042
Fax 926 0
+61 3 99030556
Email 926 0
henry.krum@med.monash.edu.au