Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001201561
Ethics application status
Approved
Date submitted
30/10/2015
Date registered
5/11/2015
Date last updated
20/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomized, placebo-controlled study of the safety and tolerability of PTG-100 in healthy volunteers
Scientific title
A randomized, double-blind, placebo-controlled study of single and multiple ascending doses of PTG-100 in normal healthy volunteers.
Secondary ID [1] 287752 0
None
Universal Trial Number (UTN)
U1111-1175-9986
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gastrointestinal 296624 0
Condition category
Condition code
Oral and Gastrointestinal 296863 296863 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral administration
Starting dose 100mg, then 300mg and 1000mg.
Single (=1 day) and multiple (=14 days) for each dose of PTG-100
Each dose tested in a new cohort
Intervention code [1] 293147 0
Treatment: Drugs
Comparator / control treatment
placebo consists of buffer/excipient without any active drug
Control group
Placebo

Outcomes
Primary outcome [1] 296465 0
Safety and tolerability will be assessed using vital signs, clinical safety labs, ECGs, physical exams and adverse events.
Timepoint [1] 296465 0
daily in-patient monitoring for 2 days following first dose in single dose part of the study and daily plus two days after last dose in multiple dose part.
Subjects return for end of study visit 7 days after last dose.
Secondary outcome [1] 318508 0
PK sample parameters include Cmax, Tmax and AUC calculated from blood plasma samples.
Timepoint [1] 318508 0
PK samples will be collected at the following time points:
0, 15 mins, 30 mins, and hours 1, 2, 4, 8, 12, 24, 36, and 48 after the dose in the single dose part and also at the same time points in the multiple dose part on days 1, 11 and 14.

Eligibility
Key inclusion criteria
Normal healthy volunteers 18-55 years
Good general health
BMI 18-30kg/m2
Lab values within normal range
Ability and willingness to attend visits to the site
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
History of significant abnormalities or diseases
Clinical significant lab or ECG abnormalities
Mentally or legally incapacitated
History of substance abuse
Inability to comply with the requirements of the study protocol

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/12/2015
Actual
17/12/2015
Date of last participant enrolment
Anticipated
Actual
23/05/2016
Date of last data collection
Anticipated
Actual
18/07/2016
Sample size
Target
70
Accrual to date
Final
78
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292294 0
Commercial sector/Industry
Name [1] 292294 0
Protagonist Therapeutics
Country [1] 292294 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Protagonist Therapeutics Pty Ltd
Address
306 Carmody Road
St Lucia
Brisbane
4067
QLD
Country
Australia
Secondary sponsor category [1] 290979 0
Commercial sector/Industry
Name [1] 290979 0
CNS Pty Ltd
Address [1] 290979 0
88 Jephson Street
Toowong
QLD 4066
Country [1] 290979 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293770 0
The Alfred Office of Ethics and Research Governance
Ethics committee address [1] 293770 0
The Alfred Hospital
55 Commercial Rd
Melbourne
VIC 3004
Ethics committee country [1] 293770 0
Australia
Date submitted for ethics approval [1] 293770 0
26/10/2015
Approval date [1] 293770 0
02/12/2015
Ethics approval number [1] 293770 0

Summary
Brief summary
The study is to assess the safety and tolerability of PTG-100 to normal healthy volunteers.
This includes vital signs, safety labs and physical examinations

The drug will be given in single ascending then multiple ascending doses.

The study will also evaluate the PK of the drug after dose administration.
Participants will be entered into standard study cohorts
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61230 0
Dr Jason Lickliter
Address 61230 0
Nucleus Network Ltd
5th Floor, Burnet Tower, AMREP Precinct
89 Commercial Road
Melbourne, Victoria, 3004
Country 61230 0
Australia
Phone 61230 0
+61 3 9076 8960
Fax 61230 0
Email 61230 0
J.Lickliter@nucleusnetwork.com.au
Contact person for public queries
Name 61231 0
Mr Lucio Tozzi
Address 61231 0
521 Cottonwood Drive, Ste 100
Milpitas, CA 95035
Country 61231 0
United States of America
Phone 61231 0
+1 408 649 7370
Fax 61231 0
Email 61231 0
l.tozzi@protagonist-inc.com
Contact person for scientific queries
Name 61232 0
Mr Lucio Tozzi
Address 61232 0
521 Cottonwood Drive, Ste 100
Milpitas, CA 95035
Country 61232 0
United States of America
Phone 61232 0
+1 408 649 7370
Fax 61232 0
Email 61232 0
l.tozzi@protagonist-inc.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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.