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

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

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-14

Study Completion Date

2016-04-26

Brief Summary

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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.

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Detailed Description

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This is a phase 1 randomized (study medication is assigned by chance), open-label (all people know the identity of the intervention), parallel-group, sequential study in healthy adult participants to investigate the effect of different storage conditions for RPV-LA on the single-dose pharmacokinetics of rilpivirine (RPV) after intramuscular injection. A total of 60 healthy adult participants will be enrolled in this study. The study will consist of 2 treatment sessions in a fixed sequential order : session 1 of up to day 8, all participants will receive a single oral dose of rilpivirine 25 milligram (mg) tablet on day 1, session 2 will consists of 2 treatment groups. The participants will be randomized in session 2 on Day 1 in a 1:1 ratio to Treatments A and B. Each treatment group will receive one 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 6.5 months. Safety will be monitored throughout the study.

Conditions

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Human Immunodeficiency Virus Type 1

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rilpivirine Long-Acting Parenteral Formulation (RPV-LA)

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.

Group Type EXPERIMENTAL

Rilpivirine (RPV)

Intervention Type DRUG

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

Rilpivirine Long-Acting Parenteral Formulation (RPV-LA)

Intervention Type DRUG

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

Aged RPV-LA

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.

Group Type EXPERIMENTAL

Rilpivirine (RPV)

Intervention Type DRUG

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

Aged RPV-LA

Intervention Type DRUG

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

Interventions

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Rilpivirine (RPV)

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

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes