NCT07349758 Evaluation of Single Dosing With Two F/TAF Tablets Among Healthy Volunteers
| NCT ID | NCT07349758 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Johns Hopkins University |
| Condition | Healthy Volunteer |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2026-01-06 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2026-01-06 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * ≥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 Criteria: * 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
Contact & Investigator
Sunil Solomon, MD
PRINCIPAL INVESTIGATOR
Johns Hopkins University
Frequently Asked Questions
Who can join the NCT07349758 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Healthy Volunteer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07349758 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07349758 currently recruiting?
Yes, NCT07349758 is actively recruiting participants. Contact the research team at jhoffm45@jh.edu for enrollment information.
Where is the NCT07349758 trial being conducted?
This trial is being conducted at Baltimore, United States.
Who is sponsoring the NCT07349758 clinical trial?
NCT07349758 is sponsored by Johns Hopkins University. The principal investigator is Sunil Solomon, MD at Johns Hopkins University. The trial plans to enroll 24 participants.