Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001019998
Ethics application status
Approved
Date submitted
14/08/2020
Date registered
7/10/2020
Date last updated
7/07/2021
Date data sharing statement initially provided
7/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1 Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Selgantolimod upon Co-administration with a Representative Proton Pump Inhibitor or H2-Receptor Antagonist
Scientific title
A Phase 1 Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Selgantolimod upon Co-administration with a Representative Proton Pump Inhibitor or H2-Receptor Antagonist in healthy adults
Secondary ID [1] 302033 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B 318611 0
Condition category
Condition code
Oral and Gastrointestinal 316630 316630 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 317289 317289 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two Cohorts:
- a Representative Proton Pump Inhibitor
- H2-Receptor Antagonist

Cohorts will be staggered with Cohort 1 enrolled, dosed and completed over a 10 day period prior to enrolling Cohort 2 and completion over a 23 day period.

Meals will be provided to participants with the following make up: 1900 kcal/day (+- 5%), with breakfast consisting of 27% fat (162 kcal).

Participants in Cohort 1 can not take part in Cohort 2.

Participants in each cohort will receive all treatments.

Cohort 1:
Treatment A Single dose of Selgantolimod 1.5 mg administered orally (tablet) in the AM under fasted conditions (10 hours fasted except for water) on Day 1

Treatment B: Omeprazole 40 mg administered orally (capsule) once daily in the AM on an empty stomach (4 hours fasted except for water) on Days 4 – 8.

Treatment C: Single dose of omeprazole 40 mg administered orally (capsule) in the AM 2 hours before a single dose of Selgantolimod 1.5 mg administered orally (tablet) under fasted conditions (10 hours fasted except for water) on Day 9.

Cohort 2:
Treatment D: Single dose of Selgantolimod 1.5 mg administered orally (tablet) in the AM under fasted conditions (10 hours fasted except for water) on Day 1

Treatment E: Single dose of Selgantolimod 1.5 mg co-administered orally (tablet) with famotidine 40 mg (tablet) in the AM under fasted conditions (10 hours fasted except for water) on Day 8

Treatment F: Single dose of famotidine 40 mg administered orally (tablet) in the PM (under fed conditions) of Day 14 approximately 12 hours before the AM dose of Selgantolimod 1.5 mg administered orally (tablet) under fasted conditions (10 hours fasted except for water) on Day 15.

Treatment G: Single dose of famotidine 40 mg administered orally (tablet) in the AM 2 hours before a single dose of Selgantolimod 1.5 mg administered orally (tablet) under fasted conditions (10 hours fasted except for water) on Day 22.
Intervention code [1] 318329 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324753 0
- PK parameters AUC last, Cmax, and AUC inf of Selgantolimod with or without PPI via blood samples.

Timepoint [1] 324753 0
Cohort 1:
Days 1, 9

Cohort 2:
Days 1, 8, 15, 22
Primary outcome [2] 325077 0
- PK parameters AUC last, Cmax, and AUC inf of Selgantolimod with or without H2RA via blood samples.
Timepoint [2] 325077 0
Cohort 1:
Days 1, 9

Cohort 2:
Days 1, 8, 15, 22
Secondary outcome [1] 385678 0
- Incidences of AEs including Nausea, Vomiting, Headache or fatigue assessed by the site investigators during discussions with participants.
Timepoint [1] 385678 0
Daily

Cohort 1
Day 1-8

Cohort 2
Day 1-23
Secondary outcome [2] 386763 0
- Incidences of laboratory abnormalities via blood samples.
Timepoint [2] 386763 0
Cohort 1:
Days 8, 10, EOT

Cohort 2:
Days 7, 14, 21, 23, EOT
Secondary outcome [3] 386764 0
- Relevant PD markers of staggered and/or co-administration of Selgantolimod with H2RA and PPI versus Selgantolimod alone via blood samples.
Timepoint [3] 386764 0
Cohort 1:
Days 1, 4, 9

Cohort 2:
Days 1, 8, 15, 22

Eligibility
Key inclusion criteria
- Screening laboratory evaluations and 12-lead ECG evaluations must be without clinically
significant abnormalities as assessed by the investigator
- Must, in the opinion of the investigator, be in good health based upon medical history and
physical examination, including vital signs
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Pregnant or Breastfeeding
- Have received any study drug within 30 days prior to study dosing
- Have poor venous access that limits phlebotomy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
The primary hypothesis test will be conducted using a Two One-sided Tests method with a 5% significant level for each test. Assuming a true GLSM ratio of 1.0 and the within-subject SD of differences is no more than 0.562, estimated from previous Gilead Studies GS-US-389-2021 and GS-US-389-3979, a sample size of 23 evaluable subjects per cohort will provide at least 80% power that the 90% CI of the GLSM ratio of test versus reference treatments with regards to AUCinf will be contained within [0.70, 1.43]. With approximately 10% overage, a total sample size of 25 subjects per cohort will be required.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/10/2020
Date of last participant enrolment
Anticipated
23/11/2020
Actual
7/12/2020
Date of last data collection
Anticipated
31/12/2020
Actual
20/04/2021
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17259 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 30971 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 306454 0
Commercial sector/Industry
Name [1] 306454 0
Gilead Sciences
Country [1] 306454 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Level 6, 417 St Kilda Road
Melbourne Vic 3004
Country
Australia
Secondary sponsor category [1] 306976 0
None
Name [1] 306976 0
Address [1] 306976 0
Country [1] 306976 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306661 0
Alfred Health Human Research Ethics Committee
Ethics committee address [1] 306661 0
Ethics committee country [1] 306661 0
Australia
Date submitted for ethics approval [1] 306661 0
02/09/2020
Approval date [1] 306661 0
30/09/2020
Ethics approval number [1] 306661 0

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

Contacts
Principal investigator
Name 104594 0
Dr Jason Lickliter
Address 104594 0
Nucleus Network Pty Ltd
Level 1, 484 St Kilda Road, Melbourne VIC 3004
Country 104594 0
Australia
Phone 104594 0
+61 3 9076 8960
Fax 104594 0
Email 104594 0
[email protected]
Contact person for public queries
Name 104595 0
Jemma Evans
Address 104595 0
Nucleus Network Pty Ltd
Level 1, 484 St Kilda Road, Melbourne VIC 3004
Country 104595 0
Australia
Phone 104595 0
+61 404 182 903
Fax 104595 0
Email 104595 0
[email protected]
Contact person for scientific queries
Name 104596 0
Jason Lickliter
Address 104596 0
Nucleus Network Pty Ltd
Level 1, 484 St Kilda Road, Melbourne VIC 3004
Country 104596 0
Australia
Phone 104596 0
+61 3 9076 8960
Fax 104596 0
Email 104596 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
Study is for supporting compound development only.


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.