Characterization of Doxycycline Pharmacokinetics and Adherence

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
HIV Prevention Trials Network
Study ID
NCT07755618
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Sexually Transmitted Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Single-Dose PK Phase - DR Group — DRUG
    One 200 mg doxycycline hyclate delayed release (DR) tablet
  • Single-Dose PK Phase - IR Group — DRUG
    Two 100 mg doxycycline hyclate immediate-release (IR) tablets
  • Multi-Dose PK Phase - Daily Group — DRUG
    One 200 mg doxycycline hyclate delayed release (DR) tablet every 24 hours
  • Multi-Dose PK Phase - Intermittent Group — DRUG
    One 200 mg doxycycline hyclate delayed release (DR) tablet every 72 hours

Study Details

The purpose of this study is to evaluate the effect of body changes on doxycycline concentrations for different dosing schedules. This study will involve a single dose phase and a multiple dose phase. Healthy individuals who do not have a sexually transmitted infection (STI), including acute (e.g., gonorrhea or chlamydia) or chronic (e.g., HIV or HSV-2) infections will be enrolled in this study. Study participants will be randomized to a dosing schedule in each phase and come to the research clinic throughout their time on study for sample collection. Study participants that choose to enroll in this study will be enrolled for about 37 days.

Key Dates

First listed
Aug 10, 2026
Start date
Aug 1, 2026
Status verified
Aug 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Single-Dose PK Phase- 200mg delayed release (DR) doxycycline tablet
    Participants in this arm will take one 200 mg delayed release (DR) doxycycline hyclate tablet
  • Experimental: Multi-Dose PK Phase- daily dosing (every 24 hours)
    Participants randomized to this arm will receive one 200mg doxycycline hyclate delayed release (DR) tablet daily (every 24 hours) for 10 days.
  • Experimental: Single Dose PK Phase- Two 100mg immediate release (IR) doxycycline tablets
    Participants in this arm will take two 100mg immediate release (IR) doxycycline hyclate tablets
  • Experimental: Multi-dose PK Phase- Intermittent (every 72 hours) dosing
    Participants randomized to this arm will receive one 200mg doxycycline hyclate delayed release (DR) tablet intermittently (every 72 hours) for 10 days.

Primary Outcome Measure

Maximum observed plasma concentration (Cmax) for 200mg doxycycline hyclate after a single dose. [ Time Frame: 1, 2, 3, 4, 6, 8, 24, 72, 96, 168, 240, and 336 hours post dose. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
John Franzone, MD
[email protected]
919-966-2537

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By research site
University of North Carolina at Chapel Hill· Chapel Hill, NC

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