- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02547870
A Study to Evaluate the Pharmacokinetic Effects of Different Storage Conditions for a Long-Acting Nanosuspension of Rilpivirine on Pharmacokinetics
November 12, 2018 updated by: Janssen Infectious Diseases BVBA
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Antwerp, Belgium
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Participants will receive one oral tablet of rilpivirine 25 milligram (mg) once on Day 1 of session 1.
Participants will receive one intramuscular (IM) injection of rilpivirine long-acting parenteral formulation 600 mg once on day 1 of session 2.
|
Experimental: 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.
|
Participants will receive one oral tablet of rilpivirine 25 milligram (mg) once on Day 1 of session 1.
Participants will receive one intramuscular (IM) injection of aged rilpivirine long-acting parenteral formulation 600 mg once on day 1 of session 2.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Observed Plasma Concentration (Cmax)
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
|
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])
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
|
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])
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
|
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])
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events
Time Frame: Up to 180 Days
|
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.
|
Up to 180 Days
|
Time to reach the maximum observed plasma concentration (Tmax)
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
|
The Tmax is the actual sampling time to reach 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
|
Elimination Rate Constant (Lambda [z]) 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
|
The Lambda (z) determined by linear regression of the terminal points of the ln-linear plasma concentration-time curve.
|
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
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
|
Apparent terminal elimination half-life, calculated as 0.693/Lambda (z).
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 14, 2015
Primary Completion (Actual)
April 26, 2016
Study Completion (Actual)
April 26, 2016
Study Registration Dates
First Submitted
September 10, 2015
First Submitted That Met QC Criteria
September 10, 2015
First Posted (Estimate)
September 11, 2015
Study Record Updates
Last Update Posted (Actual)
November 14, 2018
Last Update Submitted That Met QC Criteria
November 12, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Rilpivirine
Other Study ID Numbers
- CR107976
- TMC278LAHTX1001 (Other Identifier: Janssen Infectious Diseases BVBA)
- 2015-002259-92 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Human Immunodeficiency Virus Type 1
-
Merck Sharp & Dohme LLCWithdrawnHIV-1 | Immunodeficiency Virus Type 1, Human | Human Immunodeficiency Virus Type 1 | Human Immunodeficiency Virus 1
-
MacroGenicsNational Institute of Allergy and Infectious Diseases (NIAID); National Institutes... and other collaboratorsActive, not recruitingHuman Immunodeficiency Virus I Infection | Immunodeficiency Virus Type 1, Human | Human Immunodeficiency Virus Type 1United States
-
Janssen Sciences Ireland UCCompletedImmunodeficiency Virus Type 1, HumanUnited States, France, Poland, United Kingdom, Belgium, Germany, Spain, Canada, Russian Federation, Puerto Rico
-
Bristol-Myers SquibbCompletedHuman Immunodeficiency Virus Type 1 (HIV-1)United States
-
Bristol-Myers SquibbCompletedHIV Infections | Human Immunodeficiency Virus Type 1 (HIV-1)United States, Netherlands
-
Tibotec Pharmaceuticals, IrelandCompletedHIV Infections | HIV-1 | Human Immunodeficiency Virus Type 1United States, Australia, France, United Kingdom, Taiwan, Spain, Argentina, Portugal, Romania, South Africa, Canada, Denmark, Sweden, Netherlands, Brazil, Puerto Rico, Austria, Russian Federation, Thailand, Mexico
-
ViiV HealthcareJanssen Research and DevelopmentCompletedHuman Immunodeficiency Virus Type 1 (HIV-1)Germany, Spain, United States, Italy, Canada, Argentina, Sweden
-
Janssen PharmaceuticaWithdrawnHuman Immunodeficiency Virus Type 1 (HIV-1) Infection
-
ViiV HealthcareGlaxoSmithKline; Janssen PharmaceuticalsCompletedHuman Immunodeficiency Virus Type 1 (HIV-1)United States, Spain, Canada, United Kingdom, South Africa, Japan
-
Janssen R&D IrelandCompletedHuman Immunodeficiency Virus Type 1United States, France, United Kingdom, Belgium, Spain, Switzerland, Sweden, Canada, Puerto Rico, Poland
Clinical Trials on Rilpivirine (RPV)
-
National Institute of Allergy and Infectious Diseases...ViiV HealthcareRecruitingHIV InfectionsThailand, United States, Puerto Rico, Botswana, South Africa, Uganda
-
Gilead SciencesCompletedHIV-1 InfectionUnited States, Spain, United Kingdom, Netherlands, Germany, Canada, Sweden, Switzerland, Italy, Belgium, Puerto Rico, France
-
Janssen Sciences Ireland UCViiV HealthcareApproved for marketing
-
Chiang Mai UniversityUnknownHIV-1-infection | Neurocognitive DysfunctionThailand
-
National Institute of Allergy and Infectious Diseases...ViiV HealthcareRecruitingHIV InfectionsUnited States, Puerto Rico
-
ViiV HealthcareGlaxoSmithKline; Janssen PharmaceuticalsActive, not recruitingHIV Infections | Infection, Human Immunodeficiency VirusGermany, Spain, France, United States, Canada, Australia, Korea, Republic of, Italy, South Africa, Russian Federation, Argentina, Mexico, Sweden
-
ViiV HealthcareJanssen, LPCompletedHIV InfectionsUnited States, Netherlands, Germany, Canada, Australia, Belgium, France, Spain, Ireland, Italy, United Kingdom, Austria, Japan, Switzerland
-
ViiV HealthcareGlaxoSmithKline; Janssen PharmaceuticalsActive, not recruitingHIV InfectionsUnited States, Germany, Netherlands, Spain, France, Canada, United Kingdom, Italy, South Africa, Russian Federation, Japan
-
AIDS Clinical Trials GroupNational Institute of Allergy and Infectious Diseases (NIAID)CompletedHIV-1 InfectionUnited States
-
University College, LondonLondon School of Hygiene and Tropical Medicine; MRC/UVRI and LSHTM Uganda Research... and other collaboratorsRecruitingHIV Infections | Hiv | HIV-1-infection | Paediatric Human Immunodeficiency Virus InfectionUganda, Zimbabwe, South Africa, Kenya