GS-3107

Associated long-acting platforms

Oral solid form

Administration route

Oral

Therapeutic area(s)

Use case(s)

Use of drug

Dosage

Drug information

Delivery device(s)

Not provided

Scale-up prospects

Not provided

Tentative equipment list for manufacturing

Not provided

Manufacturing

Not provided

Specific analytical instrument required for characterization of formulation

Not provided

ACTRN12626000118303

Identifier

GS-US-756-7894

Link

https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=ACTRN12626000118303

Phase

Phase I

Status

Not yet recruiting

Sponsor

Gilead Sciences

More details

This Phase 1 study will evaluate the safety, tolerability, and PK of oral GS 3107 in combination with oral encequidar (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)

Purpose

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

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
2026-02-10

Actual Start Date
Not provided

Anticipated Date of Last Follow-up
Not provided

Estimated Primary Completion Date
2026-09-12

Estimated Completion Date
Not provided

Actual Primary Completion Date
Not provided

Actual Completion Date
Not provided

Studied populations

Age Cohort

• Adults

Genders

• All

Accepts pregnant individuals
No

Accepts lactating individuals
No

Accepts healthy individuals
Yes

Comments about the studied populations

18 year(s) to 55 year(s) ; BMI between 19 and 32 kg/m 2; non-smokers

Health status

Study type

Interventional (clinical trial)

Enrollment

16

Allocation

Non-randomized

Intervention model

Sequential assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Studied LA-formulation(s)

Studied route(s) of administration

Use case

Unspecified

Key resources

Proprietary excipients used

Not provided

Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration

Not provided

Residual solvents used

Not provided

There are either no relevant patents or these were not yet submitted to LAPaL

Publications

There are no publication

Additional documents

• UNIADS- Beyond 2025 – Long acting antiretrovirals: potential to close HIV prevention and treatment gaps

• TAG-Pipeline report 20255 - Antiretroviral Therapy

Useful links

There are no additional links

	Collaborate for development Consider on a case by case basis, collaborating on developing long acting products with potential significant public health impact, especially for low- and middle-income countries (LMICs), utilising the referred to long-acting technology Not provided
	Share technical information for match-making assessment Provide necessary technical information to a potential partner, under confidentiality agreement, to enable preliminary assessment of whether specific medicines of public health importance in LMICs might be compatible with the referred to long-acting technology to achieve a public health benefit Not provided
	Work with MPP to expand access in LMICs In the event that a product using the referred to long-acting technology is successfully developed, the technology IP holder(s) will work with the Medicines Patent Pool towards putting in place the most appropriate strategy for timely and affordable access in low and middle-income countries, including through licensing Not provided

Not provided