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Doxycycline Pharmacokinetics Study

BA
MR
Overseen ByMichelle Robinson
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: HIV Prevention Trials Network
Must not be taking: Anticonvulsants, Iron, Antacids
Disqualifiers: STIs, Pregnancy, Hepatitis B, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

MC

Mackenzie Cottrell, PharmD, MS

Principal Investigator

University of North Carolina, Chapel Hill

MM

Mark Marzinke, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18-65 who do not have any sexually transmitted infections or major health issues. Participants must be able to swallow pills, use video calls, and women of childbearing age must use two forms of birth control and test negative for pregnancy.

Inclusion Criteria

For females of reproductive potential: Using at least two effective methods of contraception for at least 30 days prior to enrollment and intending to use two effective methods of contraception for the duration of study participation, with at least one barrier method recommended
Has access to a smartphone and/or laptop and is able and willing to participate in video-based communications with study staff for directly observed dosing requirements
Has and is able to maintain a caput (head) of hair, that has not been chemically treated and is greater than one centimeter in length for the duration of the study
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Exclusion Criteria

Participation in research studies involving drugs, products, or vaccines within 30 days of enrollment and for the duration of the study
Has donated approximately 1 pint (550 mL) of blood within 8 weeks of enrollment
Has evidence or history of any condition that would make study participation unsafe, complicate interpretation of study outcome data, or interfere with achieving study objectives as judged by the investigator
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Single-Dose PK Phase

Participants receive a single dose of doxycycline to evaluate pharmacokinetics

1 day
Multiple visits for sample collection

Multi-Dose PK Phase

Participants receive multiple doses of doxycycline to evaluate pharmacokinetics and adherence

10 days
Regular visits for sample collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 days
Final visit on Day 37

What Are the Treatments Tested in This Trial?

Trial Overview

The study is testing how the body processes doxycycline when taken as a single dose or in different multiple-dose schedules. Participants are randomly assigned to dosing groups and monitored over about 37 days with clinic visits for sample collection.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Single-Dose PK Phase- 200mg delayed release (DR) doxycycline tabletExperimental Treatment1 Intervention
Group II: Single Dose PK Phase- Two 100mg immediate release (IR) doxycycline tabletsExperimental Treatment1 Intervention
Group III: Multi-dose PK Phase- Intermittent (every 72 hours) dosingExperimental Treatment1 Intervention
Group IV: Multi-Dose PK Phase- daily dosing (every 24 hours)Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

HIV Prevention Trials Network

Lead Sponsor

Trials
31
Recruited
569,000+

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborator

Trials
3,361
Recruited
5,516,000+

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