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

NCT05112939 | Completed Phase 1 FDA Drug

• 3 other identifiers: CR109089TMC278LAHTX10032021-002697-31
• Study Type: interventional
• Target: 126
• Locations: 2 countries
• Sites: 3

Brief 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 participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Plasma Concentration of Rilpivirine (RPV)

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

  Up to 72 weeks

• Plasma Concentration of Cabotegravir (CAB)

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

  Up to 72 weeks

Secondary Outcomes (4)

• Number of Participants With Adverse Events (AEs)

  Up to 72 weeks

• Number of Participants with Injection-Site Reactions

  Up to 72 weeks

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

  Up to 72 weeks

• Pain Assessment using Visual Analogue Scale (VAS)

  Up to 72 weeks

Study Arms (5)

Panel A: Rilpivirine (RPV) Long-acting (LA)

EXPERIMENTAL

Participants will receive one dose of RPV LA (formulation 1) under different conditions (Treatment A and B) on Day 1.

Drug: RPV LA

Panel B: RPV LA

EXPERIMENTAL

Participants will receive one dose of RPV LA (formulation 2) under different conditions (Treatment C and D) on Day 1.

Drug: RPV LA

Panel C: RPV LA

EXPERIMENTAL

Participants 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.

Drug: RPV LA

Panel D: RPV LA

EXPERIMENTAL

Participants 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.

Drug: RPV LA

Panel E: RPV LA + Cabotegravir (CAB) LA

EXPERIMENTAL

Participants will receive one dose of RPV LA (formulation 1) with CAB LA (formulation 3) (Treatment I) on Day 1.

Drug: RPV LA; Drug: CAB LA

Interventions

RPV LA DRUG

RPV LA will be administered at different formulations.

Also known as: TMC278

Panel A: Rilpivirine (RPV) Long-acting (LA); Panel B: RPV LA; Panel C: RPV LA; Panel D: RPV LA; Panel E: RPV LA + Cabotegravir (CAB) LA

CAB LA DRUG

CAB LA will be administered at formulation 3.

Also known as: GSK1265744

Panel E: RPV LA + Cabotegravir (CAB) LA

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (3)

PRA Health Sciences

Lenexa, Kansas, 66219, United States

Location

PRA Health Sciences

Salt Lake City, Utah, 84124, United States

Location

PRA Health Sciences

Groningen, NZ 9728, Netherlands

Location

MeSH Terms

Interventions

Rilpivirine; cabotegravir

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 9, 2021
• Study Start: November 16, 2021
• Primary Completion: May 23, 2024
• Study Completion: May 23, 2024
• Last Updated: February 28, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

US (2); NL (1)