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Study of F/TAF Tablets in Healthy Volunteers

This study is testing a single, higher dose of two F/TAF (tenofovir alafenamide/emtricitabine) tablets in healthy volunteers. F/TAF is a medication used for HIV prevention. Researchers want to understand how your body processes this dose over 14 days. To join, you must be at least 18 years old, in good general health, have non-reactive HIV test results, and an estimated glomerular filtration rate (eGFR) of 70 mL/min or higher. The main goal is to measure the levels of tenofovir-diphosphate inside your cells after 168 hours (7 days). The current recruitment status is unclear, and the study plans to enroll 24 participants.

Study design
This is an interventional study involving 24 healthy volunteers. It is not specified if the study is blinded or randomized.
What's involved
You would receive a single dose of two F/TAF tablets and be followed for 14 days. Intensive blood draws will occur shortly after dosing, becoming less frequent over the 14 days.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 14 days after receiving the dose, with the primary measurement taken at 168 hours (7 days).

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NCT07349758

Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers

Recruiting
PHASE1Ages 18+Interventional
Johns Hopkins University
~24 participants
Updated 2026-02-13 on ClinicalTrials.gov
What's tested:tenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mg

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intracellular tenofovir-diphosphate concentrations (fmol/10^6)
Measured over 168 hours

Conditions

Healthy Volunteer
HIV Prevention

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Healthy Volunteer

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Sunil Solomon, MD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Jennifer Hoffmann, CRNP
[email protected]
410-955-1318
Email the study team

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Eligibility criteria

Inclusion

≥18 years of age, inclusive on the date of screening
Provides written informed consent for the study
Good general health, as determined by medical history, physical examination, vital signs, screening laboratory tests
Non-reactive HIV test results within four weeks of enrollment
An estimated glomerular filtration rate (eGFR) of ≥ 70 mL/min/1.73 m2 via the CKD-EPI 2021 eGFRCr equation
Agrees to use condoms for all sexual events during study participation
Willing to abstain from oral PrEP use outside of study products for the duration of the study

Exclusion

History of oral PrEP (F/TDF or F/TAF) use in the preceding two months
Persons who have a reactive or positive HIV result from screening visit.
Positive hepatitis B surface antigen (HBsAg) test
Participants with a history of having a gastrectomy, colostomy, ileostomy, or any other procedure altering the gastrointestinal tract or drug absorption
History of any behaviors that place the participant at high-risk for HIV acquisition (e.g., needle sharing, unprotected sex with ≥1 partner in the prior 2 weeks)
Taking concomitant medications that that are known inducers/inhibitors of P-gp that would effect TAF absorption
Pregnancy or lactation
Any other condition or prior therapy that, in the opinion of the investigator, would preclude informed consent, make study participation unsafe, make the individual unsuitable for the study or unable to comply with the study requirements. Such conditions may include, but are not limited to, current or recent history of severe, progressive, or uncontrolled substance abuse, or renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, or cerebral disease

What this trial measures

  • Intracellular tenofovir-diphosphate concentrations (fmol/10^6)168 hours