ANZCTR - Registration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12625001353482

Ethics application status

Approved

Date submitted

2/10/2025

Date registered

3/12/2025

Date last updated

19/10/2026

Date data sharing statement initially provided

3/12/2025

Type of registration

Prospectively registered

Titles & IDs

Public title

A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GS-3107 Coadministered with Encequidar in Healthy Participants

Scientific title

A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GS-3107 Coadministered with Encequidar in Healthy Participants

Additional trial identifiers [1]

GS-US-756-7894

Universal Trial Number (UTN)

Trial acronym

Related trial records

Health condition

Health condition(s) studied:

HIV-1 Infection

Condition category

Condition code

Infection

Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure

Study type

Interventional

Description of the intervention or exposure

The study will proceed governed by a review of safety and available PK data and applicable stopping rules. Each cohort is open label with no arms within each cohort. Dose selection, dose frequency, dose and meal conditions will be determined by Safety Review Team evaluation of previous dosing cohorts.

Part A: Cohorts 1 and 2 (GS-3107 + encequidar methanesulfonate (ECD))

- Cohort 1: single dose of 1800 mg (oral tablets) GS-3107 coadministered with 15 mg (oral tablets) ECD in the fed state within 5 minutes of completing a low-fat meal, approximately 400-500 calories with 25% of calories from fat.

- Cohort 2: single dose of 1800 mg (oral tablets) GS-3107 coadministered with 15 mg (oral tablets) ECD in the fasted state following an overnight fast (no food or drinks except water for at least 10 hours)

Intervention code [1]

Treatment: Drugs

Description of the comparator or control

No control group.

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To evaluate the effect of coadministration of GS-3107 with encequidar methanesulfonate (ECD) on plasma exposures of LEN assessed by plasma PK parameters AUClast, AUCinf, and Cmax of LEN and additional metabolites, as applicable, when GS 3107 is coadministered with ECD.

Timepoint [1]

Intensive plasma PK sampling Part A (Cohorts 1 and 2): predose (less than or equal to 5 min before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, and 264 hours postdose. Single timed PK sampling Part A, Cohorts 1 and 2: Days 15, 22, 29, 36, 43, 50, and 60 A single anytime PK sample will be collected at the early termination (ET) visit, as applicable (all cohorts)

Primary outcome [2]

To evaluate the safety and tolerability of GS-3107 and ECD when coadminstered

Timepoint [2]

This will be assessed daily through confinement (Day -1 to Day 15 for Part A (Cohort 1-2)) to discharge. Participants will be assessed in Part A on Day 22, Day 29, Day 36, Day 43, Day 50, Day 60.

Secondary outcome [1]

To characterize the PK of ECD when coadminstered with GS-3107

Timepoint [1]

Intensive plasma PK sampling Part A (Cohorts 1 and 2): predose (less than or equal to 5 min before dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, and 264 hours postdose. Single timed plasma PK sampling Part A, Cohorts 1 and 2: Days 15, 22, 29, 36, 43, 50, and 60 A single anytime PK sample will be collected at the early termination (ET) visit, as applicable (all cohorts)

Secondary outcome [2]

To evaluate the urine PK of GS-3107 and/or metabolites

Timepoint [2]

Part A (Cohorts 1 and 2) Urine PK sampling will occur relative to the administration of study drug. Predose (less than or equal to 30 min before dose), 0 to 6 hours, 6 to 12 hours, 12 to 24 hours, 24 to 48 hours, 48 to 72 hours, 72 to 120 hours, 120 to 168 hours, 168 to 216, 216 to 264, and 264 to 336 hours postdose

Eligibility

Key inclusion criteria

Participants must meet the following key inclusion criteria:

- Healthy males and females aged between 18 and 55
- BMI between 19 and 32 kg/m 2
- Be a non-smoker with the discontinuation of nicotine or nicotine containing products greater than or equal to 90 days prior to first dose of the study drug
- Not currently take any regular prescription medication
- If a female of childbearing potential and engage in heterosexual intercourse, must be on a non-hormonal form of contraception or have a partner that has had a vasectomy and refrain from egg donation and in vitro fertilization during the study through the end of the contraception requirement
- If male of childbearing potential and engage in heterosexual intercourse, must agree to use condoms and refrain from sperm donation during the study through the end of the contraception requirement
- Be at low risk of HIV-1 as assessed by the investigator
- Have a negative pregnancy test at screening and admission

Minimum age

18 Years

Maximum age

55 Years

Sex

Both males and females

Healthy volunteers

Yes

Key exclusion criteria

Participants who meet any of the following key exclusion criteria are not eligible to be enrolled in this study:

- Have known hypersensitivity to the study drug or its components
- Have a serious or active medical or psychiatric illness that would interfere with participant treatment, assessment or compliance with the protocol in the opinion of the investigator
- Are currently breastfeeding
- Have current alcohol or substance abuse judged by the investigator to interfere with compliance or safety, or a positive drug or alcohol test at screening or admission
- Have a positive test result for HIV-1/2, hepatitis B, or hepatitis C at screening
- Require ongoing prohibited medications or have recently used study drugs or immunosuppressive therapies
- Have taken any prescription medications or over-the-counter medications within 28 days prior to the start of study drug dosing
- Plan to donate sperm or eggs during or within 60 days after the study

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

Completed

Date of first participant enrolment

Anticipated

4/12/2025

Actual

9/12/2025

Date of last participant enrolment

Anticipated

15/07/2026

Actual

10/12/2025

Date of last data collection

Anticipated

12/09/2026

Actual

13/02/2026

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Gilead Sciences Inc

Address [1]

Country [1]

United States of America

Primary sponsor type

Commercial sector/Industry

Name

Gilead Sciences Inc

Address

Country

United States of America

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Health and Disability Ethics Committee

Ethics committee address [1]

https://ethics.health.govt.nz/about/central-health-and-disability-ethics-committee/

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

02/10/2025

Approval date [1]

17/11/2025

Ethics approval number [1]

Summary

Brief summary

This Phase 1 study will evaluate the safety, tolerability, and PK of oral GS 3107 in combination with oral ECD in healthy participants. The results from this study will inform the feasibility of long interval dosing of GS 3107 with ECD for the prevention of HIV 1 infection, or to be used in combination with other antiretroviral agents for HIV 1 treatment. This study provides comparisons of PK and generates safety data for the expected therapeutic range of drug exposures planned for evaluation in subsequent studies. 

This is an open label study with adaptive dose selection in healthy adult participants to evaluate the effect of coadministration of GS 3107 and ECD on the PK of LEN (administered as LEN prodrug, GS-3107) in Part A. 

Cohorts 3 to 8 are not part of this registration form but are optional which will only initiate if deemed necessary at the discretion of the sponsor based on Safety Review Team review of safety, tolerability, and  available PK data from all participants enrolled in the previous dosing cohort(s). The additional cohorts will evaluate the effect of food on the PK of ECD in Part B, and the effect of P-gp inhibition by ECD on a probe substrate in Part C, and the PK of GS-3107 when given alone in Part D.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Rohit Katial

Address

New Zealand Clinical Research, 3 Ferncroft Street, Grafton, Auckland 1010 NZ

Country

New Zealand

Phone

+6493733474

Fax

[email protected]

Contact person for public queries

Name

Rohit Katial

Address

New Zealand Clinical Research, 3 Ferncroft Street, Grafton, Auckland 1010 NZ

Country

New Zealand

Phone

+6493733474

Fax

[email protected]

Contact person for scientific queries

Name

Rohit Katial

Address

New Zealand Clinical Research, 3 Ferncroft Street, Grafton, Auckland 1010 NZ

Country

New Zealand

Phone

+6493733474

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: Study is 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.

Trial Review

Documents added manually

Documents added automatically