Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000573954
Ethics application status
Approved
Date submitted
6/04/2020
Date registered
15/05/2020
Date last updated
15/05/2020
Date data sharing statement initially provided
15/05/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Relative Oral Bioavailability of a Tablet Formulation vs a Solution
of PLN-74809 in Healthy Participants
Scientific title
The Relative Oral Bioavailability of a Tablet Formulation vs a Solution
of PLN-74809 in Healthy Participants
Secondary ID [1] 299730 0
PLN-74809-106
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic pulmonary fibrosis 315076 0
Primary Sclerosing Cholangitis 315783 0
Condition category
Condition code
Respiratory 313416 313416 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 314069 314069 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 314070 314070 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a single center, 2-period, sequence-randomized, crossover, single-dose,
open-label study in 24 healthy participants. Participants will receive a single dose
of PLN 74809 on 2 occasions in randomized sequence, as an 40-mg oral solution and as a 40-mg tablet.
The 2 administrations will be separated by a washout period of approximately 2 weeks.

Intervention is administered directly by staff at a Phase 1 unit. Laboratory test will also be monitored to assess adherence.
Intervention code [1] 315993 0
Treatment: Drugs
Comparator / control treatment
Active Control treatment will be the previously studied PLN-74809 in an Oral Solution (control).
Control group
Active

Outcomes
Primary outcome [1] 321894 0
To assess the relative oral bioavailability of a tablet vs. a solution of PLN-74809 in healthy participants.

Single -dose pharmacokinetics (PK) of PLN-74809 will be assessed using plasma blood samples.

Parameters to be examined include: AUC, Cmax, tmax, t 1/2, CL/F, VzF, R cmax, R auc.
Timepoint [1] 321894 0
Blood samples for the assay of PLN-74809 will be collected at up to 19 pre-determined timepoints over the 8 day confinement periods of treatment period 1 and treatment period 2.
Secondary outcome [1] 376609 0
To assess the safety and tolerability of a single dose of PLN-74809 in healthy
participants.
Timepoint [1] 376609 0
Safety and tolerability of PLN-74809 assessments will be collected for 28 days (+/-3 days) following the first dose of PLN-74809.

Safety and tolerability will be assessed by physical exam, vital signs, ECG and laboratory testing.

Monitoring for adverse events and concomitant medications will be conducted at frequent intervals when housed in the clinic from the time of the signed consent to the End of Study visit.

Eligibility
Key inclusion criteria
1. 18 to 55 years
2. Good general health, with no significant medical history and no clinically significant
abnormalities at screening and/or before administration of the initial dose of study drug.
3. Body weight greater than or equal to 50 kg at the Screening Visit.
4. Body mass index (BMI) between 18 and 30 kg/m2, inclusive.
5. Participants must use adequate contraception for male and female participants of childbearing potential.
6. Understand the study procedures and agrees to participate in the study by giving written informed consent.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History of clinically significant abnormalities or diseases.
- Pregnant or lactating females.
- Positive test for hepatitis C antibody (HCVAb), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at Screening.
- Positive toxicology screening panel
- History of substance abuse or dependency or history of recreational drug use.
- Alcohol consumption greater than 14 drinks per week for males (7 for females).
- Smokers or ‘vapers’ (cigarette or other modalities).
- Unable to refrain from or anticipates the use of any medications, including prescription and non-prescription drugs and herbal supplements.
- Unlikely to comply with the study protocol or, in the opinion of the Investigator, would not be a suitable candidate for participation in the study.
- Have participated in any other investigational drug trial within 30 days or 5 half-lives (whichever is longer) of dosing in the present 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)
Computer generated randomisation schedule will be prepared by a statistician prior to the start of the study. Subjects will receive PLN-74809 on two occasions, in a randomised sequence, once as an oral solution and once as a tablet, in a 1: 1 ratio,

Copies of the randomization sequence and treatment codes will be available to all study personnel as this study is open label.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization scheme and codes will be generated by a Statistician and provided to the site prior to study commencement.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Bio-availability
Statistical methods / analysis
The Sample size has been set based on a typical size for a study of this type.

Safety population data from all participants who receive at least one dose of study drug will be included in the safety analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
24/01/2020
Date of last participant enrolment
Anticipated
Actual
31/01/2020
Date of last data collection
Anticipated
Actual
20/04/2020
Sample size
Target
24
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15110 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 28405 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 304202 0
Commercial sector/Industry
Name [1] 304202 0
Pliant Therapeutics, Inc.
Country [1] 304202 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Pliant Therapeutics, Inc.
Address
260 Littlefield Avenue,
South San Francisco,
CA 94080, USA
Country
United States of America
Secondary sponsor category [1] 304434 0
Commercial sector/Industry
Name [1] 304434 0
InClin Pty Ltd
Address [1] 304434 0
210 / 25 Berry Street
North Sydney, NSW
Australia, 2060
Country [1] 304434 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304669 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 304669 0
Ethics committee country [1] 304669 0
Australia
Date submitted for ethics approval [1] 304669 0
07/11/2019
Approval date [1] 304669 0
16/12/2019
Ethics approval number [1] 304669 0
708/19

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

Contacts
Principal investigator
Name 97794 0
Dr Ingrid Hopper
Address 97794 0
The Nucleus Network Burnet Tower AMREP Precinct 89 Commercial Rd Melbourne VIC 3001
Country 97794 0
Australia
Phone 97794 0
+61 3 9076 8960
Fax 97794 0
Email 97794 0
[email protected]
Contact person for public queries
Name 97795 0
Taylor Kilfoil
Address 97795 0
InClin Pty. Ltd.
210 / 25 Berry Street
North Sydney, NSW
Australia, 2060
Country 97795 0
Australia
Phone 97795 0
+61 408 880 403
Fax 97795 0
Email 97795 0
[email protected]
Contact person for scientific queries
Name 97796 0
Erica Park
Address 97796 0
Pliant Therapeutics, Inc.
260 Littlefield Avenue,
South San Francisco,
CA 94080, USA
Country 97796 0
United States of America
Phone 97796 0
+1 415 215 7768
Fax 97796 0
Email 97796 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data to remain confidential


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.