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

NCT07349758 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: IRB00488588DP1DA060602
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the pharmacokinetics of a one-time dosing of two F/TAF tablets over a 14-day period.

Conditions

Healthy Volunteer; HIV Prevention

Keywords

HIV PrEP; healthy volunteer

Outcome Measures

Primary Outcomes (1)

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

  168 hours

Study Arms (1)

F/TAF dosing

EXPERIMENTAL

Received one-time dosing of two F/TAF tablets

Drug: tenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mg

Interventions

tenofovir alafenamide [TAF] 50 mg/emtricitabine [FTC] 400mg DRUG

One-time dose of two F/TAF tablets

F/TAF dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

RECRUITING

MeSH Terms

Interventions

tenofovir alafenamide; Emtricitabine; Racivir

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Sunil Solomon, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Hoffmann, CRNP

CONTACT

410-955-1318; jhoffm45@jh.edu

Pooja Akoijam, MD

CONTACT

410-955-1201; pakoija1@jh.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 20, 2026
• Study Start: January 6, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)