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Trial registered on ANZCTR


Registration number
ACTRN12614001022651
Ethics application status
Approved
Date submitted
12/09/2014
Date registered
24/09/2014
Date last updated
4/08/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
First-in-Human, Single Ascending Oral Dose Study of DV-928 in Healthy Volunteers
Scientific title
A First-in-Human, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of DV-928 in Healthy Volunteers
Secondary ID [1] 285329 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment of Fatty Liver Disease 293053 0
Condition category
Condition code
Metabolic and Endocrine 293326 293326 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
DV-928 powder for reconstitution and oral administration.
Each subject will receive a single dose of either active DV-928 or placebo (calcium carbonate) according to the Cohort they are participating in and the intervention they are randomised to.
1. The doses of the intervention are described below per cohort:
* Cohort 1: DV-928 or placebo (30 mg)
* Cohort 2: DV-928 or placebo (100 mg)
* Cohort 3: DV-928 or placebo (300 mg)
* Cohort 4: DV-928 or placebo (600 mg)
* Cohort 5: DV-928 or placebo (1000 mg)
Intervention code [1] 290240 0
Treatment: Drugs
Comparator / control treatment
Placebo (Calcium carbonate powder for reconstitution)
Each subject will receive a single dose of either active DV-928 or placebo (calcium carbonate) according to the Cohort they are participating in and the intervention they are randomised to.
Control group
Placebo

Outcomes
Primary outcome [1] 293152 0
Primary Outcome 1:
To evaluate the safety and tolerability of single, ascending oral doses of DV-928 in healthy volunteers.
Timepoint [1] 293152 0
Timepoint for Primary Outcome 1: Various safety measures including safety laboratory tests, 12-lead ECGs and Adverse Events collected at various timepoints in the 48 hours post study drug administration and during the 7-day follow up visit.

Primary outcome [2] 293153 0
Primary Outcome 2:
To characterize the pharmacokinetics of DV-928 in plasma following administration of single, ascending oral doses in healthy volunteers
Timepoint [2] 293153 0
Timepoint for Primary Outcome 2: PK samples at pre-dose (pre-dose, representing baseline concentration levels) and at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-dose.
Secondary outcome [1] 310462 0
To determine any dose limiting adverse drug effects following single ascending oral dosing of DV-928 in healthy volunteers.

Routine vital sign measurements (blood pressure [BP], pulse and respiratory rate [RR]) will be measured at various timepoints from screening until trial completion.
Physical examinations will be performed at screening, Day -1, and at trial completion.
Safety Laboratory tests (Chemistry, Hematology, Gamma-glutamyl transpeptidase (GGT), and Urinalysis) will be drawn at various timepoints from screening until trial completion.
Twelve-lead ECGs will be obtained from subjects at various timepoints from screening until 48 hours post dose and additional ECGs may be obtained if clinically indicated.
Timepoint [1] 310462 0
Timepoint: Adverse events will be reported following study drug administration throughout the 7 day duration of each cohort, for all cohorts.

Eligibility
Key inclusion criteria
- Be in good health as determined by medical history, physical examination, 12 lead ECG and clinical laboratory evaluations at screening;
- Male subjects must agree to use a medically acceptable method of contraception/birth control throughout the study duration and for 90 days after the study is completed.
- Female subjects must be of non-childbearing potential
Minimum age
19 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Significant blood loss or donated blood in the 30 days prior to study participation
- Participation in an investigational drug study within 30 days prior to dosing.
- History of drug or alcohol abuse.
- Use of any medications, including OTC and herbal or nutritional supplements during the week prior to drug dosing
- Positive tests for HIV, hepatitis B/C, drugs of abuse or alcohol breath-test.
- Clinically significant abnormalities

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)
Six subjects per cohort will be randomized with a 2:1 randomization whereby 4 subjects receive DV-928 and 2 subjects receive placebo. The dose will be provided to blinded study staff in a blinded fashion.

A Master Randomization schedule will be held off-site by an unblinded Pharmacist. Once the PI confirms eligibility a Subject Randomisation Number will be allocated and provided to the unblinded Pharmacist. The unblinded Pharmacist will reference the randomization schedule and prepare and dispense DV-928 or placebo to each patient according to their Subject Randomisation number. No other site staff have access to the Master Randomisation Schdeule and therefore remain blinded at all times.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table/schedule generated by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other
Other design features
Six subjects per cohort with a 2:1 randomization ratio will be treated with 4 subjects receiving DV-928 and 2 subjects receiving placebo for a total of 5 cohorts (30 subjects total will be enrolled). Each cohort of 6 subjects continues only after the safety assessment of the previous cohort.
For Cohort 1 only, sentinel dosing will be used. For all other cohorts, the 6 subjects will be dosed on the same day.
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis
Safety – Safety will be evaluated by assessment of clinical laboratory tests, physical examinations including vital signs, and ECGs, and by the documentation of all spontaneously reported adverse events.
Pharmacokinetics – Plasma concentration data of DV-928 and its metabolite at each dose level will be used to calculate relevant pharmacokinetic parameters.
Pharmacokinetic parameters will summarized by dose level using descriptive statistics.
Due to the exploratory nature of this first-in-human study, no power or sample size calculations have been performed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/10/2014
Actual
16/10/2014
Date of last participant enrolment
Anticipated
11/01/2015
Actual
4/02/2015
Date of last data collection
Anticipated
15/02/2016
Actual
15/02/2016
Sample size
Target
36
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 8693 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 289947 0
Commercial sector/Industry
Name [1] 289947 0
DURECT Corporation
Country [1] 289947 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
INC Research
Address
159 Port Rd, Hindmarsh South Australia, 5007
Country
Australia
Secondary sponsor category [1] 288637 0
None
Name [1] 288637 0
Address [1] 288637 0
Country [1] 288637 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291663 0
The Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 291663 0
Ethics committee country [1] 291663 0
Australia
Date submitted for ethics approval [1] 291663 0
25/08/2014
Approval date [1] 291663 0
01/10/2014
Ethics approval number [1] 291663 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51418 0
Dr Jason Lickliter
Address 51418 0
Nucleus Network
5th Floor, Burnet Tower, AMREP Precinct
89 Commercial Road
Melbourne, Victoria, Australia, 3004
Country 51418 0
Australia
Phone 51418 0
+ 61 3 9076 8906
Fax 51418 0
+ 61 3 9076 8911
Email 51418 0
j.lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 51419 0
Jemma Lawson
Address 51419 0
INC Research, Level 1, 159 Port Road, Hindmarsh, SA 5007, Australia
Country 51419 0
Australia
Phone 51419 0
+61 8 7202 1510
Fax 51419 0
+61 8 7202 1599
Email 51419 0
jemma.lawson@increserach.com
Contact person for scientific queries
Name 51420 0
Jemma Lawson
Address 51420 0
INC Research, Level 1, 159 Port Road, Hindmarsh, SA 5007, Australia
Country 51420 0
Australia
Phone 51420 0
+61 8 7202 1510
Fax 51420 0
+61 8 7202 1599
Email 51420 0
jemma.lawson@increserach.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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