NCT02547870

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 14, 2015

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2016

Completed
Last Updated

November 14, 2018

Status Verified

November 1, 2018

Enrollment Period

9 months

First QC Date

September 10, 2015

Last Update Submit

November 12, 2018

Conditions

Human Immunodeficiency Virus Type 1

Keywords

RilpivirineHealthy participants

Outcome Measures

Primary Outcomes (4)

  • Maximum Observed Plasma Concentration (Cmax)

    The Cmax is the maximum observed plasma concentration of rilpivirine.

    In session1: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours post-dose; In session 2: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168,216, 264, 336, 408, 528, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose

  • Area Under the Plasma Concentration-Time Curve From Time Zero (Day 1) to Day 28 (AUC[0-d28])

    The AUC (0-d28) is the area under the plasma concentration-time curve for rilpivirine from time zero to day 28.

    In session1: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours post-dose; In session 2: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose

  • Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])

    The AUC (0-last) is the area under the plasma concentration-time curve for rilpivirine from time zero to last quantifiable time.

    In session1: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours post-dose; In session 2: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168,216, 264, 336, 408, 528, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose

  • Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])

    The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentrationtime curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.

    In session1: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours post-dose; In session 2: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168,216, 264, 336, 408, 528, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose

Secondary Outcomes (4)

  • Number of Participants With Adverse Events

    Up to 180 Days

  • Time to reach the maximum observed plasma concentration (Tmax)

    In session1: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours post-dose; In session 2: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168,216, 264, 336, 408, 528, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose

  • Elimination Rate Constant (Lambda [z]) of rilpivirine

    In session1: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours post-dose; In session 2: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168,216, 264, 336, 408, 528, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose

  • Apparent Terminal Half-life (t[1/2]) of rilpivirine

    In session1: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours post-dose; In session 2: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168,216, 264, 336, 408, 528, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose

Study Arms (2)

Rilpivirine Long-Acting Parenteral Formulation (RPV-LA)

EXPERIMENTAL

Participants will receive oral tablet of rilpivirine 25 milligram (mg) once on Day 1 of session 1 and intramuscular (IM) injection of rilpivirine long-acting parenteral formulation 600 mg once on day 1 of session 2.

Drug: Rilpivirine (RPV)Drug: Rilpivirine Long-Acting Parenteral Formulation (RPV-LA)

Aged RPV-LA

EXPERIMENTAL

Participants will receive oral tablet of rilpivirine 25 milligram (mg) once on Day 1 of session 1 and IM injection of aged rilpivirine long-acting parenteral formulation 600 mg once on day 1 of session 2.

Drug: Rilpivirine (RPV)Drug: Aged RPV-LA

Interventions

Rilpivirine (RPV)DRUG

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

Aged RPV-LARilpivirine Long-Acting Parenteral Formulation (RPV-LA)
Rilpivirine Long-Acting Parenteral Formulation (RPV-LA)DRUG

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

Rilpivirine Long-Acting Parenteral Formulation (RPV-LA)
Aged RPV-LADRUG

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

Aged RPV-LA

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Each participant must sign an Informed Consent Form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and are willing to participate in the study
  • Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
  • Participant must be healthy on the basis of a medical evaluation that reveals the absence of any clinically significant abnormality and includes a physical examination, medical history, vital signs, Electrocardiogram (ECG), and the results of blood biochemistry, hematology and coagulation tests and a urinalysis performed at Screening
  • A female participant of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[beta-hCG\]) at Screening and a negative urine pregnancy test on day 1
  • Participant must be non-smoking for at least 3 months prior to selection

You may not qualify if:

  • Female participant who is breastfeeding at Screening
  • Participants with a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the participant or that could prevent, limit or confound the protocol specified assessments. This may include, but is not limited to, renal dysfunction, significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
  • Has known allergies, hypersensitivity, or intolerance to rilpivirine (RPV) or its excipients
  • Has a history of drug allergy such as, but not limited to, sulfonamides and penicillins, or drug allergy witnessed in previous studies with experimental drugs
  • Having donated or lost more than 1 unit of blood (500 milliliter \[mL\]) within 60 days or more than 1 unit of plasma within 7 days before the first dose of study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Antwerp, Belgium

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Rilpivirine

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Janssen Infectious Diseases BVBA Clinical Trial

    Janssen Infectious Diseases BVBA

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2015

First Posted

September 11, 2015

Study Start

August 14, 2015

Primary Completion

April 26, 2016

Study Completion

April 26, 2016

Last Updated

November 14, 2018

Record last verified: 2018-11

Locations

BE(1)