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A Study to Evaluate the Pharmacokinetic Effects of Different Storage Conditions for a Long-Acting Nanosuspension of Rilpivirine on Pharmacokinetics

NCT02547870 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2018-11-14

No results posted yet for this study

Summary

The purpose of this study is to compare the single-dose pharmacokinetics of rilpivirine (RPV) after intramuscular (IM) injection of rilpivirine long-acting parenteral formulation (RPV-LA) and 'aged' RPV-LA, in healthy adult participants.

Conditions

  • Human Immunodeficiency Virus Type 1

Interventions

DRUG

Rilpivirine (RPV)

Participants will receive one oral tablet of rilpivirine 25 milligram (mg) once on Day 1 of session 1.

DRUG

Rilpivirine Long-Acting Parenteral Formulation (RPV-LA)

Participants will receive one intramuscular (IM) injection of rilpivirine long-acting parenteral formulation 600 mg once on day 1 of session 2.

DRUG

Aged RPV-LA

Participants will receive one intramuscular (IM) injection of aged rilpivirine long-acting parenteral formulation 600 mg once on day 1 of session 2.

Sponsors & Collaborators

  • Janssen Infectious Diseases BVBA

    lead INDUSTRY

Principal Investigators

  • Janssen Infectious Diseases BVBA Clinical Trial · Janssen Infectious Diseases BVBA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-08-14
Primary Completion
2016-04-26
Completion
2016-04-26

Countries

  • Belgium

Study Locations

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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 NCT02547870 on ClinicalTrials.gov