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Trial registered on ANZCTR


Registration number
ACTRN12621000612819
Ethics application status
Approved
Date submitted
14/04/2021
Date registered
21/05/2021
Date last updated
30/01/2023
Date data sharing statement initially provided
21/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1, Dose-Escalation Study in Healthy Volunteers to Evaluate the Pharmacokinetics, Safety, and Tolerability of GS-1427 Following Single and Multiple Dosing
Scientific title
A Phase 1, Dose-Escalation Study in Healthy Volunteers to Evaluate the Pharmacokinetics, Safety, and Tolerability of GS-1427 Following Single and Multiple Dosing
Secondary ID [1] 303830 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory bowel disease 321893 0
Condition category
Condition code
Oral and Gastrointestinal 319131 319131 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two parts:
- Part A: 5 cohorts Single Ascending Dose TBD during the study
- Part B: 5 cohorts Multiple ascending dose based on Part A

Mode of administration - oral capsule
The adherence is completed by the site staff watching the participant take the drug and swallow it and then doing a visual check of their mouth to ensure it has been swallowed.

Part A
Cohort 1: GS-1427 single dose on Day 1 - 20mg
Cohort 2: GS-1427 single dose on Day 1 - Upto 60mg
Cohort 3: GS-1427 single dose on Day 1 - Upto 200mg
Cohort 3: GS-1427 single dose on Day 8 - Upto 200mg
Cohort 4: GS-1427 single dose on Day 1 - Upto 500mg
Cohort 5: GS-1427 single dose on Day 1 - Upto 100mg

Part B
Cohort 6: GS-1427 twice daily for 14 days - Dose TBD
Cohort 7: GS-1427 twice daily for 14 days - Dose TBD
Cohort 8: GS-1427 twice daily for 14 days - Dose TBD
Cohort 9: GS-1427 twice daily for 14 days - Dose TBD
Cohort 10: GS-1427 once daily for 14 days - Dose TBD
Intervention code [1] 320145 0
Treatment: Drugs
Comparator / control treatment
Placebo - Gelatin Capsule
Control group
Placebo

Outcomes
Primary outcome [1] 327037 0
To characterize Cmax and AUC of GS-1427 in plasma
Timepoint [1] 327037 0
Part A
Cohorts 1, 2, 4 & 5 - Day 1 = 0.5, 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, and 96 hours post dose
Cohort 3 - Days 1 & 8 = 0.5, 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, and 96 hours post dose

Part B
Cohorts 6-10 -
Day 1 = 0.5, 1, 2, 3, 4, 6, 9, 12, 18, and 24 hours post dose and
Day 14 = 0.5, 1, 2, 3, 4, 6, 9, 12, 18, 24, 36, 48, 72, and 96 hours post dose
Secondary outcome [1] 393557 0
To evaluate the safety and tolerability of escalating single and multiple oral doses of GS-1427 Following Single and Multiple Dosing
Adverse events assessed in accordance with the Common Terminology Criteria for Adverse Events (CTCAE5.0)
Timepoint [1] 393557 0
Part A
Cohorts 1, 2, 4 & 5 - Day 1
Cohort 3 - Days 1 & 8

Part B
Cohorts 6-10 - Days 1, 3,4,5,9,13 and 14

Eligibility
Key inclusion criteria
- Be a non-smoker. 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 and < 30 kg/m2 at screening
- Must be willing and able to comply with all study requirements
- 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 female
- Have received any study drug within 30 days prior to study dosing
- Subjects must not have donated blood within 56 days of study entry or plasma within 7 days of study entry.
- Have any serious or active medical or psychiatric illness (including depression) that, in the
opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment

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
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2021
Actual
15/06/2021
Date of last participant enrolment
Anticipated
21/09/2022
Actual
3/03/2022
Date of last data collection
Anticipated
15/11/2022
Actual
17/03/2022
Sample size
Target
110
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19046 0
Nucleus Network - Melbourne
Recruitment hospital [2] 21644 0
Nucleus Network - Geelong
Recruitment postcode(s) [1] 33594 0
3004 - Melbourne
Recruitment postcode(s) [2] 36576 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 308226 0
Commercial sector/Industry
Name [1] 308226 0
Gilead Sciences
Country [1] 308226 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] 309016 0
None
Name [1] 309016 0
Address [1] 309016 0
Country [1] 309016 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308208 0
Alfred Health Human Research Ethics Committee
Ethics committee address [1] 308208 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 308208 0
Australia
Date submitted for ethics approval [1] 308208 0
05/05/2021
Approval date [1] 308208 0
31/05/2021
Ethics approval number [1] 308208 0

Summary
Brief summary
A Phase 1, randomized, placebo controlled, single and multiple ascending dose escalation study to evaluate the pharmacokinetics, safety and tolerability of GS-1427 in healthy subjects
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109934 0
Dr Philip Ryan
Address 109934 0
Nucleus Network
Level 5 Burnet Tower, 89 Commercial Road, Melbourne, Victoria, 3004
Country 109934 0
Australia
Phone 109934 0
+61 438009787
Fax 109934 0
Email 109934 0
[email protected]
Contact person for public queries
Name 109935 0
Philip Ryan
Address 109935 0
Nucleus Network
Level 5 Burnet Tower, 89 Commercial Road, Melbourne, Victoria, 3004
Country 109935 0
Australia
Phone 109935 0
+61 438009787
Fax 109935 0
Email 109935 0
[email protected]
Contact person for scientific queries
Name 109936 0
Philip Ryan
Address 109936 0
Nucleus Network
Level 5 Burnet Tower, 89 Commercial Road, Melbourne, Victoria, 3004
Country 109936 0
Australia
Phone 109936 0
+61 438009787
Fax 109936 0
Email 109936 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.