HealthyPhase 1NCT02561936
Relative Bioavailability of Three Oral Formulations Candidates of Rilpivirine for Potential Pediatric Use Compared to Oral Tablet
A Phase 1 study testing Rilpivirine Oral Tablet, Rilpivirine formulation G007 and Rilpivirine formulation G009-01 in people with Healthy, run by Janssen Sciences Ireland UC at 1 site in Belgium.
Trial summary
The purpose of this study is to compare the rate and extent of absorption of rilpivirine in healthy adult participants following: 1) administration of a single dose of two different oral dispersible tablet formulation candidates and of an oral granules formulation with that following administration of a single dose of… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rilpivirine Oral Tablet, Rilpivirine formulation G007 and Rilpivirine formulation G009-01
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2015to Apr 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be willing and able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
- 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 and hematology tests and a urinalysis performed at screening. If there are abnormalities, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the Investigator
- Female participant must be either postmenopausal(amenorrhea for at least 2 years and a serum follicle-stimulating hormone [FSH] level greater than or equal to (>) 40 international units per liter (IU/L) [to be confirmed at screening for all postmenopausal women]), OR permanently sterilized (eg, bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], total hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or otherwise incapable of becoming pregnant, and have a negative serum pregnancy test at screening
- Male participants heterosexually active with a woman of childbearing potential must agree to use two effective contraceptive methods during the study and for at least 90 days after receiving the last dose of study drugs and male participants must agree not to donate sperm during the study and for at least 90 days after receiving the last dose of study drug
- Participants must be non-smoking for at least 3 months prior to Screening
Who cannot join
- Female participants who are 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 participants 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
- Participants with current hepatitis B infection (confirmed by hepatitis B surface antigen [HBsAg]) or hepatitis C infection (confirmed by hepatitis C virus [HCV] antibody), or human immunodeficiency syndrome-1 (HIV-1 ) or HIV-2 infection
- Participants with a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (including barbiturates, opiates, cocaine, amphetamines, methadone, benzodiazepines, methamphetamine, tetrahydrocannabinol, phencyclidine, and tricyclic antidepressants) at Screening
- Participants with a history of clinically relevant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Randomized, 2-panel, 4-way Crossover Study in Healthy Adult Subjects to Assess the Rilpivirine Relative Bioavailability Compared to the 25-mg Oral Tablet and the Food Effect Following Single Dose Administration of Oral Pediatric Formulation Candidates
The purpose of this study is to compare the rate and extent of absorption of rilpivirine in healthy adult participants following: 1) administration of a single dose of two different oral dispersible tablet formulation candidates and of an oral granules formulation with that following administration of a single dose of the 25-milligram (mg) oral tablet (EDURANT), after a standardized breakfast; 2) administration of a single dose of one selected oral formulation candidate (a dispersible tablet or granules) in different fed conditions (standardized breakfast or yoghurt) and in the fasted state and breakfast and 3) administration of a single dose of one selected oral formulation candidate (a dispersible tablet or granules) dispersed in water or in orange juice, in fed condition (standardized breakfast).
Read the detailed description
This is a Phase 1, open-label, randomized, 2-panel, 4-way crossover study in healthy adult participants to assess the relative bioavailability of rilpivirine following single dose administration of oral pediatric formulation candidates (two dispersible tablet formulations and one granules formulation), compared to the commercially available 25-mg tablet (EDURANT) and to assess the effect of food and different food constituents on the oral bioavailability of rilpivirine following single dose administration of one selected formulation candidate. The study will consist of 2 panels: Panel 1 and Panel 2. In each panel, participants will be randomized to receive treatment A, B, C, D and E, F, G, H, respectively. Pharmacokinetic parameters will be evaluated primarily. Safety will be monitored throughout the study.
- Conditions
- Healthy
- Being tested
- Rilpivirine Oral Tablet, Rilpivirine formulation G007, Rilpivirine formulation G009-01, Rilpivirine formulation G002, Standardized Breakfast
- Keywords
- Healthy, EUDRANT, Rilpivirine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rilpivirine Oral TabletDrug
Also called Edurant
Rilpivirine formulated as 25 mg oral tablet.
Rilpivirine formulation G007Drug
Rilpivirine G007 formulation as 10*2.5 mg tablets.
Rilpivirine formulation G009-01Drug
Rilpivirine G009-01 formulation as 10*2.5 mg tablets.
Rilpivirine formulation G002Drug
Rilpivirine G002 formulation as 10 g of 2.5 milligram per gram (mg/gm) granules.
Standardized BreakfastDietary supplement
It will consist of (or its equivalent) 4 slices of bread, 2 slices of ham and/or cheese, butter, fruit preserve and 1 or 2 cups (up to 480 milliliter [mL]) of decaffeinated coffee or decaffeinated tea with milk and/or sugar, if desired (containing approximately fat: 21 gram (gm), carbohydrates: 67 gm, proteins: 19 gm; calories 533 kilocalorie (kcal) [189 kcal from fat, 268 kcal from carbohydrates, and 76 kcal from proteins]).
| Study group | Role | What they receive |
|---|---|---|
| Panel 1: Group 1 | Experimental | Participants will receive Treatment A (25 milligram [mg] rilpivirine [RPV] formulated as the oral tablet under fed condition [standardized breakfast]) followed by Treatment D (25 mg RPV formulated as granules formulation G002 [10 g of 2.5 mg/g granules, dispersed in water] under fed [standardized breakfast]) followed by Treatment B (25 mg RPV formulated as dispersible tablet formulation G007 [10*2.5 mg tablets, dispersed in water] under fed condition) followed by Treatment C (25 mg RPV formulated as dispersible tablet formulation G009-01 [10*2.5 mg tablets, dispersed in water] under fed condition). Receives: Drug: Rilpivirine Oral Tablet; Drug: Rilpivirine formulation G007; Drug: Rilpivirine formulation G009-01; Drug: Rilpivirine formulation G002; Dietary Supplement: Standardized Breakfast |
| Panel 1: Group 2 | Experimental | Participants will receive treatment B followed by treatment A then treatment C followed by treatment D. Receives: Drug: Rilpivirine Oral Tablet; Drug: Rilpivirine formulation G007; Drug: Rilpivirine formulation G009-01; Drug: Rilpivirine formulation G002; Dietary Supplement: Standardized Breakfast |
| Panel 1: Group 3 | Experimental | Participants will receive treatment C followed by treatment B then treatment D followed by treatment A. Receives: Drug: Rilpivirine Oral Tablet; Drug: Rilpivirine formulation G007; Drug: Rilpivirine formulation G009-01; Drug: Rilpivirine formulation G002; Dietary Supplement: Standardized Breakfast |
| Panel 1: Group 4 | Experimental | Participants will receive treatment D followed by treatment C then treatment A followed by treatment B. Receives: Drug: Rilpivirine Oral Tablet; Drug: Rilpivirine formulation G007; Drug: Rilpivirine formulation G009-01; Drug: Rilpivirine formulation G002; Dietary Supplement: Standardized Breakfast |
| Panel 2: Group 1 | Experimental | Participants will receive Treatment E (25 mg RPV formulated as dispersible tablet formulation G007 or G009-01 or as granules formulation G002 [10*2.5 mg tablets or 10 g of 2.5 mg/g granules, dispersed in water] under fed [standardized breakfast] condition) followed by Treatment H (25 mg RPV formulated as dispersible tablet formulation G007 or G009-01 or as granules formulation G002 [10*2.5 mg tablets or 10 g of 2.5 mg/g granules, dispersed in water] under fed [yoghurt] condition) followed by Treatment F (25 mg RPV formulated as dispersible tablet formulation G007 or G009-01 or as granules formulation G002 [10*2.5 mg tablets or 10 g of 2.5 mg/g granules, dispersed in water] under fasted condition) followed by Treatment G (25 mg RPV formulated as dispersible tablet formulation G007 or G009-01 or as granules formulation G002 [10*2.5 mg tablets or 10 g of 2.5 mg/g granules, dispersed in water] under fed [standardized breakfast] condition). Receives: Drug: Rilpivirine formulation G007; Drug: Rilpivirine formulation G009-01; Drug: Rilpivirine formulation G002; Dietary Supplement: Standardized Breakfast |
| Panel 2: Group 2 | Experimental | Participants will receive Treatment F followed by Treatment E then Treatment G followed by Treatment H. Receives: Drug: Rilpivirine formulation G007; Drug: Rilpivirine formulation G009-01; Drug: Rilpivirine formulation G002; Dietary Supplement: Standardized Breakfast |
| Panel 2: Group 3 | Experimental | Participants will receive Treatment G followed by Treatment F then Treatment H followed by Treatment E. Receives: Drug: Rilpivirine formulation G007; Drug: Rilpivirine formulation G009-01; Drug: Rilpivirine formulation G002; Dietary Supplement: Standardized Breakfast |
| Panel 2: Group 4 | Experimental | Participants will receive Treatment H followed by Treatment G then Treatment E followed by Treatment F. Receives: Drug: Rilpivirine formulation G007; Drug: Rilpivirine formulation G009-01; Drug: Rilpivirine formulation G002; Dietary Supplement: Standardized Breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
The Cmax is the maximum observed plasma concentration.
Measured: Up to Hour 168
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 from time zero to last quantifiable time.
Measured: Up to Hour 168
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 concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
Measured: Up to Hour 168
Secondary outcomes (5)
Time to Reach Maximum Observed Plasma Concentration (Tmax)
The Tmax is defined as time to reach maximum observed analyte concentration.
Measured: Up to Hour 168
Elimination Rate Constant (Lambda[z])
Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
Measured: Up to Hour 168
Elimination Half-Life (t1/2)
The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
Measured: Up to Hour 168
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.
Measured: From signing of the informed consent form up to 30 days after last dose of study drug (Day 1)
Number of Participants with Taste Questionnaire Score
The first part of the taste questionnaire rates sweetness, bitterness and flavour as well as overall acceptability in a 4-point scale (grading from worse to best). In the second part of the taste questionnaire the overall taste is assessed using a 5-point visual hedonic scale (categorical 5 point assessment).
Measured: 15 minutes after study drug intake in each treatment period in both panels
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Sciences Ireland UC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Sciences Ireland UC Clinical Trial, Study director, Janssen Sciences Ireland UC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02561936
- Sponsor's protocol ID
- CR107783
- Other IDs
- TMC278IFD1008, 2015-002511-14, 2015
- Status last verified
- Jan 2025
- First submitted
- 21 Aug 2015
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomized, 2-panel, 4-way Crossover Study in Healthy Adult Subjects to Assess the Rilpivirine Relative Bioavailability Compared to the 25-mg Oral Tablet and the Food Effect Following Single Dose Administration of Oral Pediatric Formulation Candidates
- ClinicalTrials.gov ID
- NCT02561936
- Acronym / sponsor ID
- CR107783
- Conditions
- Healthy
- Keywords
- Healthy, EUDRANT, Rilpivirine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Janssen Sciences Ireland UCIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 28 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the rate and extent of absorption of rilpivirine in healthy adult participants following: 1) administration of a single dose of two different oral dispersible tablet formulation candidates and of an oral granules formulation with that following administration of a single dose of the 25-milligram (mg) oral tablet (EDURANT), after a standardized breakfast; 2) administration of a single dose of one selected oral formulation candidate (a dispersible tablet or granules) in different fed conditions (standardized breakfast or yoghurt) and in the fasted state and breakfast and 3) administration of a single dose of one selected oral formulation candidate (a dispersible tablet or granules) dispersed in water or in orange juice, in fed condition (standardized breakfast).
Detailed description
This is a Phase 1, open-label, randomized, 2-panel, 4-way crossover study in healthy adult participants to assess the relative bioavailability of rilpivirine following single dose administration of oral pediatric formulation candidates (two dispersible tablet formulations and one granules formulation), compared to the commercially available 25-mg tablet (EDURANT) and to assess the effect of food and different food constituents on the oral bioavailability of rilpivirine following single dose administration of one selected formulation candidate. The study will consist of 2 panels: Panel 1 and Panel 2. In each panel, participants will be randomized to receive treatment A, B, C, D and E, F, G, H, respectively. Pharmacokinetic parameters will be evaluated primarily. Safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Panel 1: Group 1 | Experimental | Drug: Rilpivirine Oral Tablet, Drug: Rilpivirine formulation G007, Drug: Rilpivirine formulation G009-01, Drug: Rilpivirine formulation G002, Dietary Supplement: Standardized BreakfastParticipants will receive Treatment A (25 milligram [mg] rilpivirine [RPV] formulated as the oral tablet under fed condition [standardized breakfast]) followed by Treatment D (25 mg RPV formulated as granules formulation G002 [10 g of 2.5 mg/g granules, dispersed in water] under fed [standardized breakfast]) followed by Treatment B (25 mg RPV formulated as dispersible tablet formulation G007 [10*2.5 mg tablets, dispersed in water] under fed condition) followed by Treatment C (25 mg RPV formulated as dispersible tablet formulation G009-01 [10*2.5 mg tablets, dispersed in water] under fed condition). |
| Panel 1: Group 2 | Experimental | Drug: Rilpivirine Oral Tablet, Drug: Rilpivirine formulation G007, Drug: Rilpivirine formulation G009-01, Drug: Rilpivirine formulation G002, Dietary Supplement: Standardized BreakfastParticipants will receive treatment B followed by treatment A then treatment C followed by treatment D. |
| Panel 1: Group 3 | Experimental | Drug: Rilpivirine Oral Tablet, Drug: Rilpivirine formulation G007, Drug: Rilpivirine formulation G009-01, Drug: Rilpivirine formulation G002, Dietary Supplement: Standardized BreakfastParticipants will receive treatment C followed by treatment B then treatment D followed by treatment A. |
| Panel 1: Group 4 | Experimental | Drug: Rilpivirine Oral Tablet, Drug: Rilpivirine formulation G007, Drug: Rilpivirine formulation G009-01, Drug: Rilpivirine formulation G002, Dietary Supplement: Standardized BreakfastParticipants will receive treatment D followed by treatment C then treatment A followed by treatment B. |
| Panel 2: Group 1 | Experimental | Drug: Rilpivirine formulation G007, Drug: Rilpivirine formulation G009-01, Drug: Rilpivirine formulation G002, Dietary Supplement: Standardized BreakfastParticipants will receive Treatment E (25 mg RPV formulated as dispersible tablet formulation G007 or G009-01 or as granules formulation G002 [10*2.5 mg tablets or 10 g of 2.5 mg/g granules, dispersed in water] under fed [standardized breakfast] condition) followed by Treatment H (25 mg RPV formulated as dispersible tablet formulation G007 or G009-01 or as granules formulation G002 [10*2.5 mg tablets or 10 g of 2.5 mg/g granules, dispersed in water] under fed [yoghurt] condition) followed by Treatment F (25 mg RPV formulated as dispersible tablet formulation G007 or G009-01 or as granules formulation G002 [10*2.5 mg tablets or 10 g of 2.5 mg/g granules, dispersed in water] under fasted condition) followed by Treatment G (25 mg RPV formulated as dispersible tablet formulation G007 or G009-01 or as granules formulation G002 [10*2.5 mg tablets or 10 g of 2.5 mg/g granules, dispersed in water] under fed [standardized breakfast] condition). |
| Panel 2: Group 2 | Experimental | Drug: Rilpivirine formulation G007, Drug: Rilpivirine formulation G009-01, Drug: Rilpivirine formulation G002, Dietary Supplement: Standardized BreakfastParticipants will receive Treatment F followed by Treatment E then Treatment G followed by Treatment H. |
| Panel 2: Group 3 | Experimental | Drug: Rilpivirine formulation G007, Drug: Rilpivirine formulation G009-01, Drug: Rilpivirine formulation G002, Dietary Supplement: Standardized BreakfastParticipants will receive Treatment G followed by Treatment F then Treatment H followed by Treatment E. |
| Panel 2: Group 4 | Experimental | Drug: Rilpivirine formulation G007, Drug: Rilpivirine formulation G009-01, Drug: Rilpivirine formulation G002, Dietary Supplement: Standardized BreakfastParticipants will receive Treatment H followed by Treatment G then Treatment E followed by Treatment F. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Participants must be willing and able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
- 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 and hematology tests and a urinalysis performed at screening. If there are abnormalities, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the Investigator
- Female participant must be either postmenopausal(amenorrhea for at least 2 years and a serum follicle-stimulating hormone [FSH] level greater than or equal to (>) 40 international units per liter (IU/L) [to be confirmed at screening for all postmenopausal women]), OR permanently sterilized (eg, bilateral tubal occlusion [which includes tubal ligation procedures as consistent with local regulations], total hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or otherwise incapable of becoming pregnant, and have a negative serum pregnancy test at screening
- Male participants heterosexually active with a woman of childbearing potential must agree to use two effective contraceptive methods during the study and for at least 90 days after receiving the last dose of study drugs and male participants must agree not to donate sperm during the study and for at least 90 days after receiving the last dose of study drug
- Participants must be non-smoking for at least 3 months prior to Screening
Key exclusion criteria (5 listed)
- Female participants who are 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 participants 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
- Participants with current hepatitis B infection (confirmed by hepatitis B surface antigen [HBsAg]) or hepatitis C infection (confirmed by hepatitis C virus [HCV] antibody), or human immunodeficiency syndrome-1 (HIV-1 ) or HIV-2 infection
- Participants with a history of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 5 years before screening or positive test result(s) for alcohol and/or drugs of abuse (including barbiturates, opiates, cocaine, amphetamines, methadone, benzodiazepines, methamphetamine, tetrahydrocannabinol, phencyclidine, and tricyclic antidepressants) at Screening
- Participants with a history of clinically relevant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, or urticaria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rilpivirine Oral TabletAlso: EdurantRilpivirine formulated as 25 mg oral tablet. | Drug | Panel 1: Group 1, Panel 1: Group 2, Panel 1: Group 3, Panel 1: Group 4 |
| Rilpivirine formulation G007Rilpivirine G007 formulation as 10*2.5 mg tablets. | Drug | Panel 1: Group 1, Panel 1: Group 2, Panel 1: Group 3, Panel 1: Group 4, Panel 2: Group 1, Panel 2: Group 2, Panel 2: Group 3, Panel 2: Group 4 |
| Rilpivirine formulation G009-01Rilpivirine G009-01 formulation as 10*2.5 mg tablets. | Drug | Panel 1: Group 1, Panel 1: Group 2, Panel 1: Group 3, Panel 1: Group 4, Panel 2: Group 1, Panel 2: Group 2, Panel 2: Group 3, Panel 2: Group 4 |
| Rilpivirine formulation G002Rilpivirine G002 formulation as 10 g of 2.5 milligram per gram (mg/gm) granules. | Drug | Panel 1: Group 1, Panel 1: Group 2, Panel 1: Group 3, Panel 1: Group 4, Panel 2: Group 1, Panel 2: Group 2, Panel 2: Group 3, Panel 2: Group 4 |
| Standardized BreakfastIt will consist of (or its equivalent) 4 slices of bread, 2 slices of ham and/or cheese, butter, fruit preserve and 1 or 2 cups (up to 480 milliliter [mL]) of decaffeinated coffee or decaffeinated tea with milk and/or sugar, if desired (containing approximately fat: 21 gram (gm), carbohydrates: 67 gm, proteins: 19 gm; calories 533 kilocalorie (kcal) [189 kcal from fat, 268 kcal from carbohydrates, and 76 kcal from proteins]). | Dietary supplement | Panel 1: Group 1, Panel 1: Group 2, Panel 1: Group 3, Panel 1: Group 4, Panel 2: Group 1, Panel 2: Group 2, Panel 2: Group 3, Panel 2: Group 4 |
Primary outcome
Maximum Observed Plasma Concentration (Cmax)
Time frame: Up to Hour 168
The Cmax is the maximum observed plasma concentration.
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
Time frame: Up to Hour 168
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
Time frame: Up to Hour 168
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 concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
5 secondary outcomes
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time frame: Up to Hour 168
Elimination Rate Constant (Lambda[z])
Time frame: Up to Hour 168
Elimination Half-Life (t1/2)
Time frame: Up to Hour 168
Number of Participants with Adverse Events
Time frame: From signing of the informed consent form up to 30 days after last dose of study drug (Day 1)
Number of Participants with Taste Questionnaire Score
Time frame: 15 minutes after study drug intake in each treatment period in both panels
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Sciences Ireland UC Clinical Trial study director
Janssen Sciences Ireland UC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rilpivirine Oral Tablet, Rilpivirine formulation G007 and Rilpivirine formulation G009-01 in people with Healthy, run by Janssen Sciences Ireland UC at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Plasma Concentration (Cmax) (time frame: Up to Hour 168). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.