A Study to Investigate the Effect of Different Particle Sizes on the Single-dose Pharmacokinetics of Rilpivirine After Intramuscular Injection of a Long-acting Nanosuspension in Healthy Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-20

Study Completion Date

2018-04-10

Brief Summary

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The main purpose of this study is to characterize the single-dose pharmacokinetics (PK) of rilpivirine (RPV) after intramuscular (IM) injection of rilpivirine long-acting parenteral formulation (RPV LA) nanosuspensions with different particle size distribution (PSD), in healthy adult participants.

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Detailed Description

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This is a phase 1, open-label (all people know the identity of the intervention), randomized (study medication is assigned by chance), parallel-group, sequential study in healthy adult participants to characterize the single-dose pharmacokinetics (PK) of rilpivirine (RPV) after intramuscular (IM) injection of RPV LA nanosuspensions with different particle size distributions (PSD), in healthy adult participants. A total of 110 healthy adult participants will be enrolled in this study. The study will consist of 2 treatment sessions in a fixed sequential order: Session 1- all participants will receive a single oral dose of rilpivirine 25 milligram (mg) as oral immediate release solution on Day 1; Session 2- the participants will be randomized in session 2 on Day 1 in a 1:1:1:1:1 ratio to Treatments A, B, C, D and E. Each treatment group will receive a single IM injection of RPV LA on Day 1 of session 2. Session 1 and 2 will be separated by a washout period of at least 14 days. The total study duration for each participant will be approximately 9.5 months. Safety will be monitored throughout the study.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cohort 1-RPV LA: Treatment B

Participants will receive single dose of 25 milligram (mg) rilpivirine (RPV) as an oral solution on Day 1 in Session 1 and Treatment B containing a single intramuscular (IM) injection of 600 mg rilpivirine long-acting parenteral formulation (RPV LA) \[with different particle size distribution (PSD) as compared to Treatment A, D, C and E\] on Day 1 of session 2. Both the sessions are separated by a wash-out Period of at least 14 days.

Group Type EXPERIMENTAL

Rilpivirine

Intervention Type DRUG

Rilpivirine 25 mg immediate release oral solution.

Rilpivirine Long-acting Parenteral Formulation

Intervention Type DRUG

RPV LA 600 mg extended-release suspension for IM injection.

Cohort 1-RPV LA: Treatment D

Participants will receive single dose of 25 mg rilpivirine (RPV) as an oral solution on Day 1 in Session 1 and Treatment D containing a single IM injection of 600 mg RPV LA \[with different PSD as compared to Treatment A, B, C and E) on Day 1 of session 2. Both the sessions are separated by a wash-out Period of at least 14 days.

Group Type EXPERIMENTAL

Rilpivirine

Intervention Type DRUG

Rilpivirine 25 mg immediate release oral solution.

Rilpivirine Long-acting Parenteral Formulation

Intervention Type DRUG

RPV LA 600 mg extended-release suspension for IM injection.

Cohort 2-RPV LA: Treatment A

Participants will receive single dose of 25 mg rilpivirine (RPV) as an oral solution on Day 1 in Session 1 and Treatment A containing a single IM injection of 600 mg RPV LA \[with different PSD as compared to Treatment B, C, D and E\] on Day 1 of session 2. Both the sessions are separated by a wash-out Period of at least 14 days.

Group Type EXPERIMENTAL

Rilpivirine

Intervention Type DRUG

Rilpivirine 25 mg immediate release oral solution.

Rilpivirine Long-acting Parenteral Formulation

Intervention Type DRUG

RPV LA 600 mg extended-release suspension for IM injection.

Cohort 2-RPV LA: Treatment C

Participants will receive single dose of 25 mg rilpivirine (RPV) as an oral solution on Day 1 in Session 1 and Treatment C containing a single IM injection of 600 mg RPV LA \[with different PSD as compared to Treatment A, B, D and E\] on Day 1 of session 2. Both the sessions are separated by a wash-out Period of at least 14 days.

Group Type EXPERIMENTAL

Rilpivirine

Intervention Type DRUG

Rilpivirine 25 mg immediate release oral solution.

Rilpivirine Long-acting Parenteral Formulation

Intervention Type DRUG

RPV LA 600 mg extended-release suspension for IM injection.

Cohort 2-RPV LA: Treatment E

Participants will receive single dose of 25 mg rilpivirine (RPV) as an oral solution on Day 1 in Session 1 and Treatment E containing a single IM injection of 600 mg RPV LA \[with different PSD as compared to Treatment A, B, C and D\] on Day 1 of session 2. Both the sessions are separated by a wash-out Period of at least 14 days.

Group Type EXPERIMENTAL

Rilpivirine

Intervention Type DRUG

Rilpivirine 25 mg immediate release oral solution.

Rilpivirine Long-acting Parenteral Formulation

Intervention Type DRUG

RPV LA 600 mg extended-release suspension for IM injection.

Interventions

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Rilpivirine

Rilpivirine 25 mg immediate release oral solution.

Intervention Type DRUG

Rilpivirine Long-acting Parenteral Formulation

RPV LA 600 mg extended-release suspension for IM injection.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
* Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for participants participating in clinical studies
* A female participant of childbearing potential must have a negative serum beta-human chorionic gonadotropin test at screening and on Day -1 of each session
* For the duration of the study and for at least 6 months after intramuscular (IM) injection of rilpivirine long-acting parenteral formulation (RPV LA) (or 1 month after administration of rilpivirine (RPV) oral solution for participants who discontinue after Session 1), male and female participants must agree to practice effective methods of contraception, and must agree not to donate sperm (males)/eggs (ova, oocytes; for females) for the purposes of assisted reproduction
* Participant must be non-smoking for at least 3 months prior to screening

Exclusion Criteria

* Female participant who is breastfeeding at screening
* Participant 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 (such as significant diarrhea, gastric stasis, or constipation that in the investigator's opinion could influence drug absorption or bioavailability), endocrine, neurologic, hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances
* Participant has a history of clinically relevant arrhythmias or history of risk factors for Torsade de Pointes (hypokalemia, family history of long QT)
* Participant has clinically relevant, currently active, or underlying gastrointestinal, cardiovascular, nervous system, psychiatric, metabolic, renal, hepatic, respiratory, inflammatory or infectious disease
* Participant has known allergies, hypersensitivity, or intolerance to RPV or its excipients

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes