ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12617000031369

Ethics application status

Approved

Date submitted

14/12/2016

Date registered

9/01/2017

Date last updated

22/01/2020

Date data sharing statement initially provided

22/01/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Pharmacokinetic and safety study of HTD1801 and its components

Scientific title

A singe-blind, randomised, triple cross-over, single-dose pharmacokinetic and safety study of HTD1801 and its components.

Secondary ID [1]

HighTide Biopharma Pty Ltd
Protocol number: 1801.PCT001

Universal Trial Number (UTN)

U1111-1190-6978

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Primary Sclerosing Cholangitis (PSC)

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Inflammatory and Immune System

Autoimmune diseases

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The treatments are HTD1801, 1500mg, BBR 1000mg and UDCA 1000mg, one oral dose of each treatment. There will be a washout period of at least 7 days and up to 10 days..
Participants will be admitted to the treatment unit where the investigational products will be administered.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Berberine (BBR), 1000mg oral one dose
Ursodeoxycholic acid (UDCA), 1000mg, oral one dose

Control group

Active

Outcomes

Primary outcome [1]

Primary endpoint:
AUC0-t. This is assessed by obtaining the plasma concentration of each investigational product.

Timepoint [1]

This is a PK and safety study. PK measures are recorded on 12 occasions after each dosing. The post dose time points are - 30minutes, 1hr, 2hr, 3hr, 4gr, 6hr, 8hr, 12hr, 16hr, 24hr, 30hr, 36hr.

Secondary outcome [1]

Secondary endpoint:
Tmax

Timepoint [1]

Tmax is measure through serum sampling. Blood measures are recorded prior to dosing and on 12 occasions after each dosing. Safety parameters are measured through out the study. The time points are:
Pre dose, post dose measures are - 30minutes, 1hr, 2hr, 3hr, 4hr, 6hr, 8hr, 12hr, 16hr, 24hr, 30hr and 36hr.

Secondary outcome [2]

Cmax.

Timepoint [2]

Cmax is measure through serum sampling. Blood measures are recorded prior to dosing and on 12occasions after each dosing. The time points are:
Pre dose, post dose measures are - 30minutes, 1hr, 2hr, 3hr, 4hr, 6hr, 8hr, 12hr, 16hr, 24hr, 30hr and 36hr.

Secondary outcome [3]

T1/2

Timepoint [3]

T1/2 is measure through serum sampling. Blood measures are recorded prior to dosing and on 12occasions after each dosing. The time points are:
Pre dose, post dose measures are - 30minutes, 1hr, 2hr, 3hr, 4hr, 6hr, 8hr, 12hr, 16hr, 24hr, 30hr and 36hr.

Secondary outcome [4]

Adverse Events (AES). AEs will be measured through communication with the participants and through performing physical examinations.

Timepoint [4]

AEs will be monitored .at pre dose and the following post dose time points - 1hr, 4hr, 8hrs, 12hr, 16hrs, 24hrs, 30hrs and 36hrs. Physical examinations will be performed at pre dose and 1 day post dose.

Secondary outcome [5]

Blood haematology. Components are:
Haemoglobin
Haematocrit
RBC Count
Platelets Count
WBC Count
Neutrophils
Lymphocytes
Monocytes
Eosinophils
Basophils

Timepoint [5]

Blood haematology will be measure through serum sampling. Sampling will occur at the following timepoints - Pre dose, 1 day post dose.

Secondary outcome [6]

Vital signs will be measured by measuring heart rate, blood pressure, respiratory rate and temperature.

Timepoint [6]

Vital signs will be measured at pre dose and the following post dose time points - 1hr, 4hr, 8hrs, 12hr, 16hrs, 24hrs, 30hrs and 36hrs.

Secondary outcome [7]

ECGs. The electrical activity of the heart will be measured.

Timepoint [7]

ECGs will be performed at pre dose and the following post dose time points - 1hr, 4hr, 8hrs, 12hr, 16hrs, 24hrs, 30hrs and 36hrs.

Secondary outcome [8]

Blood chemistry will be measured. Components are:
Urea
Creatinine
AST
ALT
Alkaline Phosphatase
Total Bilirubin

Timepoint [8]

Blood chemistry will be measure through serum sampling. Sampling will occur at the following timepoints - Pre dose, 1 day post dose.

Eligibility

Key inclusion criteria

Males and females
18-45 years of age
BMI 20-35 kg/m2
No history of CV or any other major disease
No pathologies in blood haematology or chemistry

Minimum age

18 Years

Maximum age

45 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

BP greater than or equal to 160/95
HR greater than or equal to 100bpm or less than or equal to 45 bpm
Significant cardiac arrhythmia
Untreated hypo- or hyperthyroidism
Clinically significant liver (greater than 3 times ULN) and/or kidney impairment
Inability to tolerate UDCA or BBR
Contraindications to BBR and UDCA
G6PD deficiency
Gastritis or gastric ulcers
Pregnancy
Any background medication or dietary supplements which might alter with
pharmacokinetic profile of IMP or active controls
Any other clinically meaningful condition, in the opinion of the investigator, which
would make participation potentially unsafe

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)

Allocation is not concealed.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation using a randomisation table created by computer software

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

Intervention assignment

Crossover

Other design features

Latin square design will be used for this study

Phase

Phase 1

Type of endpoint/s

Pharmacokinetics

Statistical methods / analysis

Exploratory analyses will be made using ANCOVA.
No formal power calculation

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

13/02/2017

Actual

4/04/2017

Date of last participant enrolment

Anticipated

13/02/2017

Actual

9/06/2017

Date of last data collection

Anticipated

8/03/2017

Actual

11/07/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Nucleus Network - Melbourne

Recruitment postcode(s) [1]

3004 - Melbourne

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

HighTide Biopharma Pty Ltd

Address [1]

1 Melissa Street,
Mount Waverley
Victoria 3149

Country [1]

Australia

Primary sponsor type

Commercial sector/Industry

Name

Clinical Network Services (CNS) Pty Ltd

Address

Level 4, 88 Joseph ST
TOOWONG QLD 4066

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

HighTide Biopharma Pty Ltd

Address [1]

1 Melissa Street,
Mount Waverley, Vic 3149

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Bellberry Limited

Ethics committee address [1]

129 Glen Osmond Road
Eastwood 
South Australia 5063

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/12/2016

Approval date [1]

23/03/2017

Ethics approval number [1]

2017-02-131

Summary

Brief summary

This will be a single-blind, randomized, single-dose, triple-cross over (a Latin square design), single-centre study.  24 Subjects will be enrolled.  Each subject will receive all three treatments in random order. At each administration day approximately 1/3 of subjects will receive treatment A, 1/3 treatment B, and 1/3 treatment C and this will switch around on the second administration day and then again on third administration day until all participants have been administered all three treatments.

Screening: Subjects will be screened for the study. Eligible subjects will return for the admission to the Unit within four (4) weeks following screening. All subjects will be instructed to maintain their lifestyle and background medications, if any.

Baseline: Subjects will be admitted to the Unit in the evening of Day -1. Blood draw to establish the baseline for all measured endpoints will be drawn in the morning of Day 0. 

Randomisation: Following the completion of all baseline assessments and draws on Day 0, eligible subjects will be randomized so that approximately 1/3 of subjects will receive treatment A, 1/3 treatment B, and 1/3 treatment C. The first dose of study medication will be then promptly administered. 

Drug administration and assessment periods: Each subject will receive a drug three times in random pre-determined order, single dose, separated by at least 14 days of washout. Following each administration, blood for PK and safety will be drawn and safety and tolerability assessments will be conducted over the ensuing 36 hours.

Final tolerability/safety assessment: Approximately seven (7) days following the administration of the last medication, the site will follow up over the phone with the subjects regarding any tolerability or safety issue; if clinically necessary, they could be invited back to the Unit for follow up tests or evaluation.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Janet Wong

Address

Nucleus Network
5th Floor, Burnet Tower, AMREP Precinct
89 Commercial Road
Melbourne
Victoria, 3004

Country

Australia

Phone

+ 613 9076 8900

Fax

+ 613 9076 8911

businessdevelopment@nucleusnetwork.com.au

Contact person for public queries

Name

Steve Linberg

Address

HighTide Biopharma Pty Ltd
1Melissa Street
Mount Waverley
Victoria 3149

Country

Australia

Phone

+61 7 3719 6000

Fax

+61 7 3719 6011

slinberg@hightidebio.com

Contact person for scientific queries

Name

Steve Linberg

Address

HighTide Biopharma Pty Ltd
Melissa Street
Mount Waverley
Victoria 3149

Country

Australia

Phone

+61 7 3719 6000

Fax

slinberg@hightidebio.com

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

All publications and data analyses etc from the study would be generated by and delivered to HighTide. However the PI reviewed and signed off on both.

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.

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