To characterize the single-dose pharmacokinetic (PK) of RPV after SC administration of RPV LA suspensions with different doses and/or different particle size (PS) to support further dose and formulation selection, in healthy adult participants.To…
ID
Source
Brief title
Condition
- Immunodeficiency syndromes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Characterize the single-dose pharmacokinetic (PK) of rilpivirine (RPV) after SC
administration of rilpivirine long-acting.
Characterize the single-dose pharmacokinetic (PK) of cabotegravir (CAB) after
SC administration of cabotegravir long-acting
Secondary outcome
Evaluate the safety and tolerability of SC administration of rilpivirine
long-acting.
Adverse events, injection site reactions, vital signs, physical examination,
laboratory parameters, nd electrocardiogram (ECG) parameters.
Background summary
The drug being studied is called rilpivirine long-acting (RPV LA).
Rilpivirine is currently approved as an intramuscular injection (IM, into the
muscle) in combination with cabotegravir injection, for the treatment of HIV-1
infection.
The current study will explore giving RPV LA subcutaneously (SC, under the
skin) at different doses and/or formulations.
Study objective
To characterize the single-dose pharmacokinetic (PK) of RPV after SC
administration of RPV LA suspensions with different doses and/or different
particle size (PS) to support further dose and formulation selection, in
healthy adult participants.
To characterize the single-dose PK of RPV after subcutaneous co-administration
of CAB LA with RPV LA, in healthy adult
participants.
To characterize the single-dose PK of CAB after subcutaneous co-administration
of CAB LA with RPV LA, in healthy adult
participants.
Study design
For the study it is necessary that subjects stay in the research center for 7
days (6 nights). This will be followed by 20 visits to the research center,
including a follow-up visit.
Intervention
Panel A: Rilpivirine (RPV) Long-acting (LA)
Participants will receive one dose of RPV LA (formulation 1) under different
conditions (Treatment A and B) on Day 1.
Panel B: RPV LA
Participants will receive one dose of RPV LA (formulation 2) under different
conditions (Treatment C and D) on Day 1.
Panel C: RPV LA
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
and/or B.
Panel D: RPV LA
Participatns 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 A
and/or B.
Panel E:
Participants will receive one dose of RPV LA (formulation 1) and a single dose
of CAB LA (Treatment I)
Study burden and risks
Blood draw
Taking blood samples may cause bruising at the place where the needle goes into
the skin. Fainting, and in rare cases infection, may occur.
In total, we will take less than 220 milliliters (mL) of blood from screening
to follow-up (if no unscheduled blood draws). This amount does not cause any
problems in adults. To compare: a blood donation involves 500 mL of blood being
taken each time at once. If the investigator thinks it is necessary for the
safety of a participant, extra samples might be taken for possible additional
testing. If this happens, the total amount of blood drawn may be more than the
amount indicated above.
Heart tracing
There is generally no risk with having an ECG. The sticky patches may pull the
skin or cause redness or itching.
Coronavirus test
With a sterile swab, a smear will be made of the mucous membranes at the back
of the nose. This is done by inserting the swab into the nostril until
resistance is felt; the swab is then rotated for sample collection and removed
from the nostril. Taking the samples only takes a few seconds, but can cause
discomfort and can give an unpleasant feeling. Taking a sample from the back of
the throat may cause subject to gag. When the sample is taken from the back of
the nose, they may experience a stinging sensation and the eyes may become
watery.
Turnhoutseweg 30
Beerse B-2340
BE
Turnhoutseweg 30
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Listed location countries
Age
Inclusion criteria
Each potential participant must satisfy all of the following criteria to be
enrolled in the study:
1. Participant must be 18 to 55 years of age, extremes included, at screening.
2. Participant must be healthy on the basis of physical examination, medical
history, vital signs, and 12-lead ECG performed at screening.
3. Participant must be healthy on the basis of clinical laboratory tests
performed at screening.
4. Body mass index between 18.0 and 35.0 kg/m2, extremes included, and body
weight not less than 50.0 kg at screening.
5. Male or female.
Further criteria apply
Exclusion criteria
1. 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.
2. 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).
3. Participant has known allergies, hypersensitivity, or intolerance to
Rilpivirine, rHuPH20, or their excipients
4. Participant has a history of clinically relevant arrhythmias or history of
risk factors for Torsade de Pointes .
5. Participants with the following ECG findings, if clinically significant:
abnormal PR, QRS, and QTc intervals; rhythm abnormalities; evidence of acute
ischemic changes.
Further criteria apply
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2021-002697-31-NL |
| CCMO | NL79472.056.21 |