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HealthyPhase 1NCT05112939

A Study of a Rilpivirine Extended-Release Suspension in Healthy Participants

A Phase 1 study testing RPV LA and CAB LA in people with Healthy, run by Janssen Research & Development, LLC at 3 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to characterize the single dose pharmacokinetics (PK) and evaluate the safety and tolerability of subcutaneous administration of rilpivirine (RPV) long-acting (LA) or RPV LA in combination with cabotegravir (CAB) LA extended release suspensions in different conditions in healthy adult… 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?
RPV LA and CAB LA
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
3 sitesin 2 countries
Study dates
16 Nov 2021to 23 May 2024
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 healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) (based on the average value of triplicate ECGs) performed at screening (results must be available on Day -1)
  • Participant must be healthy on the basis of clinical laboratory tests performed at screening (results must be available prior to dosing on Day 1). 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
  • All women participants must have a negative highly sensitive serum (Beta-human chorionic gonadotropin [Beta-hCG]) pregnancy test at screening and on Day -1
  • A woman must agree not to donate eggs (ova, oocytes) or freeze for future use for the purposes of assisted reproduction during the study and for at least 72 weeks after receiving the dose of study intervention
  • A male participant (not vasectomized) who is heterosexually active with a woman of childbearing potential must agree to use two effective contraceptive methods for the duration of the study (72 weeks follow-up), or for at least 72 weeks after receiving the dose of study intervention for those who do not complete the study

Who cannot join

  • Participant with a history of or current illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study intervention to the participant or that could prevent, limit or confound the protocol specified assessments. This may include, but is not limited to, hepatic or renal dysfunction, cardiac disease, vascular, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, neurologic, hematologic, coagulation disorders (including any abnormal bleeding or blood dyscrasias), or psychiatric disturbances
  • Participant has a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
  • Participant has known allergies, hypersensitivity, or intolerance to Cabotegravir (CAB) or its excipients
  • Participants with the following ECG findings, if clinically significant: abnormal PR, QRS, and QTc intervals; rhythm abnormalities; evidence of acute ischemic changes
  • Participants with a history of clinically relevant skin disease such as, but not limited to, dermatitis, eczema, drug rash, drug allergy, psoriasis, food allergy, urticaria

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

United States2 sites

  • PRA Health Sciences 2

    Lenexa, Kansas, 66219

  • PRA Health Sciences 1

    Salt Lake City, Utah, 84124

Other trials in United States

Netherlands1 site

  • PRA Health Sciences

    Groningen, NZ 9728

Other trials in Netherlands

About this study

Official title: A Phase 1, Single-blind, Randomized, Parallel-group Study in Healthy Participants to Investigate the Single-dose Pharmacokinetics, Safety and Tolerability of Rilpivirine After Subcutaneous Administration of a Rilpivirine Extended-Release Suspension Alone, and of Rilpivirine and Cabotegravir After Co-administration With Cabotegravir Extended-Release Suspension

The purpose of this study is to characterize the single dose pharmacokinetics (PK) and evaluate the safety and tolerability of subcutaneous administration of rilpivirine (RPV) long-acting (LA) or RPV LA in combination with cabotegravir (CAB) LA extended release suspensions in different conditions in healthy adult participants.

Conditions
Healthy
Being tested
RPV LA, CAB LA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RPV LADrug

    Also called TMC278

    RPV LA will be administered at different formulations.

  • CAB LADrug

    Also called GSK1265744

    CAB LA will be administered at formulation 3.

Study groups in NCT05112939
Study groupRoleWhat they receive
Panel A: Rilpivirine (RPV) Long-acting (LA)ExperimentalParticipants will receive one dose of RPV LA (formulation 1) under different conditions (Treatment A and B) on Day 1.
Receives: Drug: RPV LA
Panel B: RPV LAExperimentalParticipants will receive one dose of RPV LA (formulation 2) under different conditions (Treatment C and D) on Day 1.
Receives: Drug: RPV LA
Panel C: RPV LAExperimentalParticipants will receive one dose of RPV LA (formulation 1) under different conditions (Treatment E and F) on Day 1, based on interim data of Panel A.
Receives: Drug: RPV LA
Panel D: RPV LAExperimentalParticipants will receive one dose of RPV LA (formulation 2) under different conditions (Treatment G and H) on Day 1, based on interim data of Panel B.
Receives: Drug: RPV LA
Panel E: RPV LA + Cabotegravir (CAB) LAExperimentalParticipants will receive one dose of RPV LA (formulation 1) with CAB LA (formulation 3) (Treatment I) on Day 1.
Receives: Drug: RPV LA; Drug: CAB LA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Plasma Concentration of Rilpivirine (RPV)

    Plasma samples will be analyzed to determine concentrations of RPV using a validated, specific, and sensitive method.

    Measured: Up to 72 weeks

  2. Plasma Concentration of Cabotegravir (CAB)

    Plasma samples will be analyzed to determine concentrations of CAB using a validated, specific, and sensitive method.

    Measured: Up to 72 weeks

Secondary outcomes (4)

  1. Number of Participants With Adverse Events (AEs)

    An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.

    Measured: Up to 72 weeks

  2. Number of Participants with Injection-Site Reactions

    Number of participants with injection-site reactions will be reported. A study intervention injection-site reaction is any adverse reaction at a subcutaneous study intervention injection-site.

    Measured: Up to 72 weeks

  3. Number of Participants with Abnormalities in 12-Lead Electrocardiograms (ECGs)

    Number of participants with abnormalities in 12- lead ECGs (heart rate, PR, QRS and QT corrected [QTc]) will be reported.

    Measured: Up to 72 weeks

  4. Pain Assessment using Visual Analogue Scale (VAS)

    Pain assessments will be performed by collecting pain intensity scores using 100-millimetre (mm) VAS.

    Measured: Up to 72 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2021
  2. Study start16 Nov 2021
  3. Primary completion23 May 2024
  4. Study completion23 May 2024

Resources

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
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05112939
Sponsor's protocol ID
CR109089
Other IDs
TMC278LAHTX1003, 2021-002697-31
Status last verified
May 2026
First submitted
2 Nov 2021
Last updated
12 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RPV LA and CAB LA in people with Healthy, run by Janssen Research & Development, LLC at 3 sites in 2 countries.

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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States, Netherlands. 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?

Plasma Concentration of Rilpivirine (RPV) (time frame: Up to 72 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05112939.

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 12 May 2026.

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Clinical Trial NCT05112939 | AzTrials