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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05112939
• Other study ID #: CR109089
• Secondary ID: TMC278LAHTX10032
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: November 16, 2021
• Est. completion date: May 23, 2024

Study information

• Verified date: March 2024
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 participants.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 126
• Est. completion date: May 23, 2024
• Est. primary completion date: May 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• RPV LA
RPV LA will be administered at different formulations.
• CAB LA
CAB LA will be administered at formulation 3.

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences	Groningen
United States	PRA Health Sciences	Lenexa	Kansas
United States	PRA Health Sciences	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Up to 72 weeks
Secondary	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.	Up to 72 weeks
Secondary	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.	Up to 72 weeks
Secondary	Pain Assessment using Visual Analogue Scale (VAS)	Pain assessments will be performed by collecting pain intensity scores using 100-millimetre (mm) VAS.	Up to 72 weeks