MedTrace Logo

Characterization of Doxycycline Pharmacokinetics and Adherence

NCT07755618 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-08-10

No results posted yet for this study

Summary

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.

Conditions

  • Sexually Transmitted Infection

Interventions

DRUG

Single-Dose PK Phase - DR Group

One 200 mg doxycycline hyclate delayed release (DR) tablet

DRUG

Single-Dose PK Phase - IR Group

Two 100 mg doxycycline hyclate immediate-release (IR) tablets

DRUG

Multi-Dose PK Phase - Daily Group

One 200 mg doxycycline hyclate delayed release (DR) tablet every 24 hours

DRUG

Multi-Dose PK Phase - Intermittent Group

One 200 mg doxycycline hyclate delayed release (DR) tablet every 72 hours

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • HIV Prevention Trials Network

    lead NETWORK

Principal Investigators

  • Mackenzie Cottrell, PharmD, MS · University of North Carolina, Chapel Hill

  • Mark Marzinke, PhD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-07-01
Completion
2027-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07755618 on ClinicalTrials.gov