Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000951752
Ethics application status
Approved
Date submitted
4/08/2013
Date registered
27/08/2013
Date last updated
5/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase I, Randomised, Double-Blind, Placebo-Controlled,Ascending
Single- and Repeat-Dose Study of the Safety,Tolerability and
Pharmacokinetics of Orally Administered PRN473.
Scientific title
A Phase I, Randomised, Double-Blind, Placebo-Controlled,Ascending
Single- and Repeat-Dose Study of the Safety,Tolerability and
Pharmacokinetics of Orally Administered PRN473
Secondary ID [1] 282955 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 289832 0
Condition category
Condition code
Other 290188 290188 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Placebo-controlled, First-In-Human study assessing the safety and tolerability of PRN473.
Approximately 64 participants in up to 6 cohorts will take part in Part A of the study. Participants in Part A of the study will receive a single dose of PRN473 (starting dose 50mg and increasing each cohort thereafter). Part A participants will receive a liquid formulation whilst fasting with the exception of 2 cross over cohorts; participants in Cohort 4a will receive the liquid formulation administered with and without food (with up to a 7 day washout between doses) and participants in Cohort 4b will be administered a tablet equivalent with and without food (with up to a 7 day washout between doses).
Approximately 50 participants in up to 5 cohorts will take part in Part B of the study. Participants in Part B of the study will receive one dose of PRN473 (tablet or liquid formulation) per day for up to 14 days (doses to be assigned based on data from part A i.e. a dose that gives roughly 30% occupancy of the target). Tablet or liquid formulation will be chosen on the basis of emerging PK and PD data from Part A of the study.
Study subjects are domiciled during the study and adherence will be monitored by study staff observations and notes, and tablet accountability or weighing the dosing syringes before and after dosing as applicable.
Intervention code [1] 287663 0
Treatment: Drugs
Comparator / control treatment
The liquid formulation placebo will be prepared for each cohort at the study site by dissolving the formula amount of hydroxypropyl-beta-cyclodextrin, vitamin E TPGS (d-alpha tocopheryl polyethylene glycol 1000 succinate), citric acid and sucralose in Water for Irrigation.

The placebo tablet is presented as an oval, scored, white tablet of approximately 1 g total weight. The tablet contains the following compendial excipients; hydroxypropyl-beta-cyclodextrin, microcrystalline cellulose, vitamin E TPGS (d-alpha tocopheryl polyethylene glycol 1000 succinate), croscarmellose sodium, and magnesium stearate. The tablets are packaged in high-density polyethylene (HDPE) containers, induction sealed, capped and labelled. Each bottle contains 30 tablets. The tablets are stored at 2–8 degrees celsius. The tablets will be administered orally to the study subject as per the clinical protocol. The tablets should be swallowed without chewing, and followed by the consumption of approximately 240 mL of water.
Control group
Placebo

Outcomes
Primary outcome [1] 290157 0
Safety and tolerability will be assessed through frequent collection of laboratory safety tests, vital signs and ECGs, and clinical monitoring of participants.
Timepoint [1] 290157 0
PartA: Up to 6 (+/-1) days after dosing
Part B: Up to 21 (+/-2) days after dosing
Secondary outcome [1] 304126 0
Nil
Timepoint [1] 304126 0
Nil

Eligibility
Key inclusion criteria
1.adult males and/or females, 18 to 55 years of age (inclusive) at the time of screening
2. Body mass index (BMI) >18.0 and < 30.5 (kg/m2) (inclusive)
3. Able to participate and comply with all study procedures and restrictions, and willing to provide written informed consent
4. If male, agrees to be sexually abstinent or to use a condom or other adequate method of contraception
5. Female participants must be surgically sterile or post-menopausal
6. Negative urine drug/alcohol breath testing at screening and check-in (Day -1).
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Pregnant or lactating females, and male partners of women who are pregnant or lactating
2. Females of child-bearing potential
3. Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV)
4. Any active acute or chronic disease judged to be clinically significant by the Investigator
5. Use of more than 1-2 tobacco/nicotine-containing products per month within 6 months prior to begining the study
6. History or presence of alcoholism or drug abuse within the 2 years prior to begining the study
7. History of any significant (as determined by the Invest
igator) drug-related allergic reactions
8. Use of any over-the-counter (OTC) medication
9. Participation in another clinical trial of a drug or device within 60 days.
10. Surgery within the past three months
11. Hypertension
12. Hypersensitivity to lactose
13. Regular alcohol consumption >14 units per week (1 unit = 1/2 pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
14. History or presence of any clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease
15. Any acute illness within 30 days prior to Day 1 of the study

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)
Participants will be recruited from the study site's internal database. Eligible subjects will be allocated to a treatment by contacting the holder of the study allocation schedule. The treatmetn allocation will be concealed from the particpant and the investigator.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation 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
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2013
Actual
1/09/2013
Date of last participant enrolment
Anticipated
7/04/2014
Actual
3/12/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
114
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 287735 0
Commercial sector/Industry
Name [1] 287735 0
Principia Biopharma Australia Pty Ltd.
Country [1] 287735 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Clinical Network Services
Address
Level 4, 88 Jephson Street, Toowong, Queensland, Australia 4066
Country
Australia
Secondary sponsor category [1] 286462 0
None
Name [1] 286462 0
Address [1] 286462 0
Country [1] 286462 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289690 0
Belberry HREC
Ethics committee address [1] 289690 0
229 Greenhill Road
Dulwich,
South Australia 5065
Ethics committee country [1] 289690 0
Australia
Date submitted for ethics approval [1] 289690 0
07/08/2013
Approval date [1] 289690 0
14/08/2013
Ethics approval number [1] 289690 0
2013-07-385

Summary
Brief summary
Placebo-controlled, First-In-Human study assessing the safety and tolerability of PRN473 in healthy volunteers. Partipants in Part A of the study will recive a single dose of PRN473. Partipants in Part B of the study will recieve one dose of PRN473 per day for up to 14 days.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41954 0
Dr Janakan Krishnarajah
Address 41954 0
Linear Clinical Research
Level 1, B Block, QEII Medical
Centre, Hospital Ave,
Nedlands WA 6009
Country 41954 0
Australia
Phone 41954 0
+61863825100
Fax 41954 0
Email 41954 0
[email protected]
Contact person for public queries
Name 41955 0
Dougal Thring
Address 41955 0
Linear Clinical Research
Level 1, B Block, QEII Medical
Centre, Hospital Ave,
Nedlands WA 6009
Country 41955 0
Australia
Phone 41955 0
+61863825100
Fax 41955 0
Email 41955 0
[email protected]
Contact person for scientific queries
Name 41956 0
Janakan Krishnarajah
Address 41956 0
Linear Clinical Research
Level 1, B Block, QEII Medical
Centre, Hospital Ave,
Nedlands WA 6009
Country 41956 0
Australia
Phone 41956 0
+61863825100
Fax 41956 0
Email 41956 0
[email protected]

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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