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

Primary Purpose

Human Immunodeficiency Virus Type 1

Status

Completed

Phase

Phase 1

Locations

Belgium

Study Type

Interventional

Intervention

Rilpivirine (RPV)

Rilpivirine Long-Acting Parenteral Formulation (RPV-LA)

Aged RPV-LA

About this trial

This is an interventional treatment trial for Human Immunodeficiency Virus Type 1 focused on measuring Rilpivirine, Healthy participants

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Rilpivirine Long-Acting Parenteral Formulation (RPV-LA)

Aged RPV-LA

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax)

The Cmax is the maximum observed plasma concentration of rilpivirine.

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.

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.

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.

Secondary Outcome Measures

Number of Participants With Adverse Events

An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Time to reach the maximum observed plasma concentration (Tmax)

The Tmax is the actual sampling time to reach maximum observed plasma concentration of rilpivirine.

Elimination Rate Constant (Lambda [z]) of rilpivirine

The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.

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

Apparent terminal elimination half-life, calculated as 0.693/Lambda (z).

Full Information

NCT ID

NCT02547870

First Posted

September 10, 2015

Last Updated

November 12, 2018

Sponsor

Janssen Infectious Diseases BVBA

1. Study Identification

Unique Protocol Identification Number

NCT02547870

Brief Title

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

Official Title

A Phase 1 Open-Label, Randomized, Parallel-Group Study in Healthy Subjects to Investigate the Effect of Different Storage Conditions of a Long-Acting Nanosuspension of Rilpivirine on the Single-Dose Plasma Pharmacokinetics of Rilpivirine After Intramuscular Injection

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

August 14, 2015 (Actual)

Primary Completion Date

April 26, 2016 (Actual)

Study Completion Date

April 26, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Infectious Diseases BVBA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Human Immunodeficiency Virus Type 1

Keywords

Rilpivirine, Healthy participants

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Rilpivirine Long-Acting Parenteral Formulation (RPV-LA)

Arm Type

Experimental

Arm Description

Arm Title

Aged RPV-LA

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Rilpivirine (RPV)

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Rilpivirine Long-Acting Parenteral Formulation (RPV-LA)

Intervention Description

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

Intervention Name(s)

Aged RPV-LA

Intervention Description

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

Primary Outcome Measure Information:

Title

Maximum Observed Plasma Concentration (Cmax)

Description

The Cmax is the maximum observed plasma concentration of rilpivirine.

Time Frame

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

Title

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

Description

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

Time Frame

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

Title

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

Description

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

Time Frame

Title

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

Description

Time Frame

Secondary Outcome Measure Information:

Title

Number of Participants With Adverse Events

Description

Time Frame

Up to 180 Days

Title

Time to reach the maximum observed plasma concentration (Tmax)

Description

The Tmax is the actual sampling time to reach maximum observed plasma concentration of rilpivirine.

Time Frame

Title

Elimination Rate Constant (Lambda [z]) of rilpivirine

Description

The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.

Time Frame

Title

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

Description

Apparent terminal elimination half-life, calculated as 0.693/Lambda (z).

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Infectious Diseases BVBA Clinical Trial

Organizational Affiliation

Janssen Infectious Diseases BVBA

Official's Role

Study Director

Facility Information:

City

Antwerp

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

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

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