A Study to Evaluate the Pharmacokinetic Effects of Different Storage Conditions for a Long-Acting Nanosuspension of Rilpivirine on Pharmacokinetics

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02547870
• Date of registration: 10/09/2015
• Prospective Registration: No
• Primary sponsor: Janssen Infectious Diseases BVBA
• Public title: A Study to Evaluate the Pharmacokinetic Effects of Different Storage Conditions for a Long-Acting Nanosuspension of Rilpivirine on Pharmacokinetics
• Scientific title: A Phase 1 Open-Label, Randomized, Parallel-Group Study in Healthy Subjects to Investigate the Effect of Different Storage Conditions of a Long-Acting Nanosuspension of Rilpivirine on the Single-Dose Plasma Pharmacokinetics of Rilpivirine After Intramuscular Injection
• Date of first enrolment: August 14, 2015
• Target sample size: 61
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02547870
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Belgium

Contacts

• Name: Janssen Infectious Diseases BVBA Clinical Trial
• Affiliation: Janssen Infectious Diseases BVBA

Key inclusion & exclusion criteria

Inclusion Criteria:

- Each participant must sign an Informed Consent Form (ICF) indicating that he or she
understands the purpose of, and procedures required for, the study and are willing to
participate in the study

- Participant must be willing and able to adhere to the prohibitions and restrictions
specified in this protocol

- Participant must be healthy on the basis of a medical evaluation that reveals the
absence of any clinically significant abnormality and includes a physical examination,
medical history, vital signs, Electrocardiogram (ECG), and the results of blood
biochemistry, hematology and coagulation tests and a urinalysis performed at Screening

- A female participant of childbearing potential must have a negative serum (beta-human
chorionic gonadotropin [beta-hCG]) at Screening and a negative urine pregnancy test on
day 1

- Participant must be non-smoking for at least 3 months prior to selection

Exclusion Criteria:

- Female participant who is breastfeeding at Screening

- Participants 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, endocrine, neurologic,
hematologic, rheumatologic, psychiatric, neoplastic, or metabolic disturbances

- Has known allergies, hypersensitivity, or intolerance to rilpivirine (RPV) or its
excipients

- Has a history of drug allergy such as, but not limited to, sulfonamides and
penicillins, or drug allergy witnessed in previous studies with experimental drugs

- Having donated or lost more than 1 unit of blood (500 milliliter [mL]) within 60 days
or more than 1 unit of plasma within 7 days before the first dose of study drug



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Human Immunodeficiency Virus Type 1

Intervention(s)

Drug: Aged RPV-LA

Drug: Rilpivirine Long-Acting Parenteral Formulation (RPV-LA)

Drug: Rilpivirine (RPV)

Primary Outcome(s)

Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity]) [Time Frame: In session1: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours post-dose; In session 2: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168,216, 264, 336, 408, 528, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose]

Area Under the Plasma Concentration-Time Curve From Time Zero (Day 1) to Day 28 (AUC[0-d28]) [Time Frame: In session1: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours post-dose; In session 2: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 and 168 hours post-dose]

Maximum Observed Plasma Concentration (Cmax) [Time Frame: In session1: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours post-dose; In session 2: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168,216, 264, 336, 408, 528, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose]

Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last]) [Time Frame: In session1: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours post-dose; In session 2: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168,216, 264, 336, 408, 528, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose]

Secondary Outcome(s)

Elimination Rate Constant (Lambda [z]) of rilpivirine [Time Frame: In session1: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours post-dose; In session 2: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168,216, 264, 336, 408, 528, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose]

Time to reach the maximum observed plasma concentration (Tmax) [Time Frame: In session1: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours post-dose; In session 2: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168,216, 264, 336, 408, 528, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose]

Apparent Terminal Half-life (t[1/2]) of rilpivirine [Time Frame: In session1: Pre-dose, 0.5, 1, 2, 3, 4, 5, 6, 9, 12, 16, 24, 48, 72, 120 and 168 hours post-dose; In session 2: Pre-dose, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168,216, 264, 336, 408, 528, 672, 1344, 2016, 2688, 3360 and 4032 hours post-dose]

Number of Participants With Adverse Events [Time Frame: Up to 180 Days]

Secondary ID(s)

CR107976

2015-002259-92

TMC278LAHTX1001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors