HealthyPhase 1NCT03127189
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
A Phase 1 study testing Rilpivirine and Rilpivirine Long-acting Parenteral Formulation in people with Healthy, run by Janssen Research & Development, LLC at 2 sites in United States.
Trial summary
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. 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 and Rilpivirine Long-acting Parenteral Formulation
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Apr 2017to 10 Apr 2018
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Celerion
Lincoln, Nebraska, 68502
Celerion
Tempe, Arizona, 85283
About this study
Official title: A Phase 1, Open-label, Randomized, Parallel-group Study in Healthy Subjects to Investigate the Effect of Different Particle Sizes on the Single-dose Pharmacokinetics of Rilpivirine After Intramuscular Injection of a Long-acting Nanosuspension
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.
Read the detailed description
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
- Healthy
- Being tested
- Rilpivirine, Rilpivirine Long-acting Parenteral Formulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RilpivirineDrug
Rilpivirine 25 mg immediate release oral solution.
Rilpivirine Long-acting Parenteral FormulationDrug
RPV LA 600 mg extended-release suspension for IM injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1-RPV LA: Treatment B | Experimental | 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. Receives: Drug: Rilpivirine; Drug: Rilpivirine Long-acting Parenteral Formulation |
| Cohort 1-RPV LA: Treatment D | Experimental | 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. Receives: Drug: Rilpivirine; Drug: Rilpivirine Long-acting Parenteral Formulation |
| Cohort 2-RPV LA: Treatment A | Experimental | 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. Receives: Drug: Rilpivirine; Drug: Rilpivirine Long-acting Parenteral Formulation |
| Cohort 2-RPV LA: Treatment C | Experimental | 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. Receives: Drug: Rilpivirine; Drug: Rilpivirine Long-acting Parenteral Formulation |
| Cohort 2-RPV LA: Treatment E | Experimental | 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. Receives: Drug: Rilpivirine; Drug: Rilpivirine Long-acting Parenteral Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Session 2: Maximum Observed Plasma Concentration (Cmax)
The Cmax is the maximum observed plasma concentration.
Measured: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 408, 528, 672, 1344, 2016, 2688, 3360, 4032, 4704, 5376, and 6048 hours post-dose
Session 2: 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 from time of administration up to Day 28 postdose.
Measured: 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 408, and 528 hours post-dose
Session 2: 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: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 408, 528, 672, 1344, 2016, 2688, 3360, 4032, 4704, 5376, and 6048 hours post-dose
Session 2: 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: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168,216, 264, 336, 408, 528, 672, 1344, 2016, 2688, 3360, 4032, 4704, 5376, and 6048 hours post-dose
Secondary outcomes (5)
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
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: Baseline, up to 9.5 months
Session 1: Maximum Observed Plasma Concentration (Cmax)
The Cmax is the maximum observed plasma concentration.
Measured: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours post-dose
Session 1: 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 from time of administration up to Day 28 postdose.
Measured: 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120, 168, hours post-dose
Session 1: 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: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours post-dose
Session 1: 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: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start20 Apr 2017
- Primary completion10 Apr 2018
- Study completion10 Apr 2018
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.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127189
- Sponsor's protocol ID
- CR108302
- Other IDs
- TMC278LAHTX1002
- Status last verified
- Jan 2025
- First submitted
- 15 Mar 2017
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- 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, Parallel-group Study in Healthy Subjects to Investigate the Effect of Different Particle Sizes on the Single-dose Pharmacokinetics of Rilpivirine After Intramuscular Injection of a Long-acting Nanosuspension
- ClinicalTrials.gov ID
- NCT03127189
- Acronym / sponsor ID
- CR108302
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 10 Apr 2018 (actual)
- Study completion
- 10 Apr 2018 (actual)
- First posted
- 25 Apr 2017 (actual)
- 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 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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort 1-RPV LA: Treatment B | Experimental | Drug: Rilpivirine, Drug: Rilpivirine Long-acting Parenteral FormulationParticipants 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. |
| Cohort 1-RPV LA: Treatment D | Experimental | Drug: Rilpivirine, Drug: Rilpivirine Long-acting Parenteral FormulationParticipants 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. |
| Cohort 2-RPV LA: Treatment A | Experimental | Drug: Rilpivirine, Drug: Rilpivirine Long-acting Parenteral FormulationParticipants 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. |
| Cohort 2-RPV LA: Treatment C | Experimental | Drug: Rilpivirine, Drug: Rilpivirine Long-acting Parenteral FormulationParticipants 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. |
| Cohort 2-RPV LA: Treatment E | Experimental | Drug: Rilpivirine, Drug: Rilpivirine Long-acting Parenteral FormulationParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| RilpivirineRilpivirine 25 mg immediate release oral solution. | Drug | Cohort 1-RPV LA: Treatment B, Cohort 1-RPV LA: Treatment D, Cohort 2-RPV LA: Treatment A, Cohort 2-RPV LA: Treatment C, Cohort 2-RPV LA: Treatment E |
| Rilpivirine Long-acting Parenteral FormulationRPV LA 600 mg extended-release suspension for IM injection. | Drug | Cohort 1-RPV LA: Treatment B, Cohort 1-RPV LA: Treatment D, Cohort 2-RPV LA: Treatment A, Cohort 2-RPV LA: Treatment C, Cohort 2-RPV LA: Treatment E |
Primary outcome
Session 2: Maximum Observed Plasma Concentration (Cmax)
Time frame: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 408, 528, 672, 1344, 2016, 2688, 3360, 4032, 4704, 5376, and 6048 hours post-dose
The Cmax is the maximum observed plasma concentration.
Session 2: Area Under the Plasma Concentration-Time Curve From Time Zero (Day 1) to Day 28 (AUC[0-d28])
Time frame: 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 408, and 528 hours post-dose
The AUC (0-d28) is the area under the plasma concentration-time curve from time of administration up to Day 28 postdose.
Session 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
Time frame: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 408, 528, 672, 1344, 2016, 2688, 3360, 4032, 4704, 5376, and 6048 hours post-dose
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
Session 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
Time frame: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168,216, 264, 336, 408, 528, 672, 1344, 2016, 2688, 3360, 4032, 4704, 5376, and 6048 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 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
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Time frame: Baseline, up to 9.5 months
Session 1: Maximum Observed Plasma Concentration (Cmax)
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours post-dose
Session 1: Area Under the Plasma Concentration-Time Curve From Time Zero (Day 1) to Day 28 AUC (0-d28)
Time frame: 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120, 168, hours post-dose
Session 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time AUC (0-last)
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours post-dose
Session 1: Area Under the Plasma Concentration-Time Curve From Time Zero To Infinite Time AUC (0-infinity)
Time frame: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours post-dose
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.
Related trials for Healthy
Recruiting
Trained vs. Untrained: Lower Extremity Pressure Changes
Trained Athletes, Untrained
Not yet recruitingPhase 1
Comparison of Pharmacokinetic/Pharmacodynamic Characteristics and Safety of GZR101-80 Injection With Separately Injected, Simultaneous Doses of GZR33 Injection and Insulin Aspart
Healthy Participants
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1
A Study of Single and Multiple Subcutaneous or Intravenous Doses of ADX-001 in Healthy Adults to Assess Safety, Effects, and Immune Response
Healthy
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 Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
2 sites 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 and Rilpivirine Long-acting Parenteral Formulation in people with Healthy, run by Janssen Research & Development, LLC at 2 sites in United States.
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 2 sites in United States. 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?
Session 2: Maximum Observed Plasma Concentration (Cmax) (time frame: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168, 216, 264, 336, 408, 528, 672, 1344, 2016, 2688, 3360, 4032, 4704, 5376, and 6048 hours post-dose). The study lists 4 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.