Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000785808
Ethics application status
Approved
Date submitted
20/04/2021
Date registered
22/06/2021
Date last updated
20/12/2021
Date data sharing statement initially provided
22/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1 Study to Evaluate the Effect of Itraconazole on the
Pharmacokinetics of GS-5718 and to Evaluate the Effect of
GS-5718 on the Pharmacokinetics of Rosuvastatin in Healthy
Subjects
Scientific title
A Phase 1 Study to Evaluate the Effect of Itraconazole on the
Pharmacokinetics of GS-5718 and to Evaluate the Effect of
GS-5718 on the Pharmacokinetics of Rosuvastatin in Healthy
Subjects
Secondary ID [1] 303650 0
Nill
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory Diseases 321042 0
Condition category
Condition code
Inflammatory and Immune System 318844 318844 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cohort 1:
GS-5718: Period 1 Day 1 (Dose 50 mg), Period 2 Day 5 (Dose 50mg), Oral Tablet
Itraconazole: Period 2: 200 mg, oral solution, twice daily, Day 1 then 200 mg, oral solution, once daily, Days 2-9

Cohort 2:
GS-5718: Period 2 (GS-5718) Days 1-10, Oral tablet 130 mg
Rosuvastatin: 10 mg Period 1 (ROS only) Day 1, Period 2 (ROS and GS-5718) Day 8, Oral tablet

Strategies used to monitor adherence: drug tablet return,
Intervention code [1] 319944 0
Treatment: Drugs
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326789 0
Cohort 1: GS-5718 Cmax and AUCinf via plasma
Timepoint [1] 326789 0
Collected Cohort 1:
Period 1: Day 1: 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 36, 48, 72, 96, 120,
144, and 168 hours postdose,


Primary outcome [2] 327958 0
Cohort 2: Rosuvastatin Cmax and AUCinf via plasma
Timepoint [2] 327958 0
Cohort 2:
Period 1 Day 1: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, and
72 hours postdose

Period 2 Day 5: 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 36, 48, 72, 96, 120,
144, and 168 hours postdose

Period 2 Day 8: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48, and
72 hours postdose
Secondary outcome [1] 392688 0
To evaluate the safety and tolerability of single and multiple GS-5718 doses administered alone or in combination with other agents

Safety of single and multiple doses of GS-5718 administered alone or in combination assessed as adverse events recorded in accordance with the Common Terminology Criteria for Adverse Events (CTCAE5.0),
Timepoint [1] 392688 0
Daily for duration of the study for all subjects

Eligibility
Key inclusion criteria
- Have the ability to understand and sign a written informed consent form (ICF), which must
be obtained prior to initiation of study procedures
- Be a nonsmoker. The use of nicotine or nicotine-containing products must be discontinued
90 days prior to the first dose of study drug.
- Have a calculated body mass index (BMI) of > 19.0 and < 30.0 kg/m2 at screening
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Positive serum pregnancy test
- Breastfeeding female
- Male subjects who plan to donate sperm from clinic admission (eg, Day -1), throughout the
study period, and/or within 14 days following the last dose of study drug
- Have received any investigational study drug within 30 days prior to study dosing
- Have current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance or subject safety, or a positive drug or alcohol test at screening or baseline

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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/07/2021
Actual
24/09/2021
Date of last participant enrolment
Anticipated
2/02/2022
Actual
Date of last data collection
Anticipated
16/03/2022
Actual
Sample size
Target
32
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 308070 0
Commercial sector/Industry
Name [1] 308070 0
Gilead Sciences
Country [1] 308070 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] 308805 0
None
Name [1] 308805 0
None
Address [1] 308805 0
None
Country [1] 308805 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308060 0
Central Adelaide Local Health Network
Ethics committee address [1] 308060 0
Port Road
Adelaide SA 5000
Ethics committee country [1] 308060 0
Australia
Date submitted for ethics approval [1] 308060 0
24/03/2021
Approval date [1] 308060 0
22/06/2021
Ethics approval number [1] 308060 0

Summary
Brief summary
The primary objective of this study is to evaluate the effect of CYP3A/P-gp inhibition on the pharmacokinetics of GS-5718 and the effect of GS-5718 on the pharmacokinetics of OATP/BCRP substrates.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109382 0
Dr Thomas Polasek
Address 109382 0
CMax
Level 5, 18a North Terrace, Adelaide, SA 5000
Country 109382 0
Australia
Phone 109382 0
+61 458162715
Fax 109382 0
Email 109382 0
tom.polasek@certara.com
Contact person for public queries
Name 109383 0
Mr Sean Connell
Address 109383 0
Gilead Sciences
Level 6, 417 St Kilda Road
MELBOURNE Vic 3004
Country 109383 0
Australia
Phone 109383 0
+61 3 92724454
Fax 109383 0
Email 109383 0
sean.connell1@gilead.com
Contact person for scientific queries
Name 109384 0
Mr Sean Connell
Address 109384 0
Gilead Sciences
Level 6, 417 St Kilda Road
MELBOURNE Vic 3004
Country 109384 0
Australia
Phone 109384 0
+61 3 92724454
Fax 109384 0
Email 109384 0
sean.connell1@gilead.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
For internal review 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.