Clinical trial NCT05112939: A Study of a Rilpivirine Extended-Release Suspension in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-11-09
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Plasma Concentration of Rilpivirine (RPV)
timeFrame: Up to 72 weeks
measure: Plasma Concentration of Cabotegravir (CAB)
timeFrame: Up to 72 weeks
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 72 weeks
measure: Number of Participants with Injection-Site Reactions
timeFrame: Up to 72 weeks
measure: Number of Participants with Abnormalities in 12-Lead Electrocardiograms (ECGs)
timeFrame: Up to 72 weeks
measure: Pain Assessment using Visual Analogue Scale (VAS)
timeFrame: Up to 72 weeks
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: PRA Health Sciences
state: Kansas
city: Salt Lake City
country: United States
facility: PRA Health Sciences
state: Utah
city: Groningen
country: Netherlands
facility: PRA Health Sciences
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: