A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants

Part of paid clinical trials in Orlando, Florida.

Sponsor
ViiV Healthcare
Study ID
NCT05418868
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • Cabotegravir 200 mg/mL — DRUG
    CAB 200 mg/mL will be administered.
  • Cabotegravir >=400 mg/mL — DRUG
    CAB \>=400 mg/mL will be administered by IM or SC injection.
  • Cabotegravir Formulation I — DRUG
    CAB Formulation I will be administered by IM injection.
  • CAB Formulation J — DRUG
    CAB Formulation J will be administered by IM injection.
  • rHuPH20 — DRUG
    rHuPH20 will be administered.
  • RPV — DRUG
    RPV will be administered by IM injection.

Study Details

This is an open-label, dose-escalation study to investigate the safety, tolerability and pharmacokinetics (PK) of single subcutaneous (SC) administration of long acting (LA) Cabotegravir (CAB) 200 milligrams per milliliter (mg/mL) with Recombinant Human Hyaluronidase PH20 (rHuPH20) (Part A), a single-dose or repeat-dose SC or intramuscular (IM) administration of LA CAB (greater than or equal to) \>=400 mg/mL (Part C), single-dose IM administration of LA CAB Formulation I (Part C Cohort C8) and LA CAB Formulation J (Part C Cohort C11), and a single-dose or repeat-dose IM administration of rilpivirine (RPV) (Part E). Part A of the study (CAB 200 mg/mL with rHuPh20) has been closed to further enrolment based on preliminary results. Part D of the study (CAB \>=400 mg/mL with rHuPH20) will not be conducted due to changes in the study design.

Key Dates

Start date
Jun 14, 2022
Status verified
Dec 2025
Primary completion
Jun 8, 2027
Completion
Jun 8, 2027

Study Design

Enrollment
214 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Participants receiving CAB 200 mg/mL with rHuPH20
    Part A of the study (CAB 200 mg/mL with rHuPh20) has been closed to further enrolment based on preliminary results.
  • Experimental: Part C: Participants receiving CAB >=400 mg/mL or CAB Formulation I or CAB Formulation J
  • Experimental: Part E: Participants receiving RPV

Primary Outcome Measure

Maximum observed plasma concentration (Cmax) of CAB and RPV [ Time Frame: Up to end of study (Week 78 for Cohorts C1 and C3 [Part C], Week 52 for Part A, Cohorts C2, C4, C5, C6, C7, C8, C9 [Part C], and Week 72 for Part E and Cohorts C10 and C11 [Part C]) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteOrlandoFlorida32806-
GSK Investigational SiteLas VegasNevada89113
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Shawn Searle (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteAustinTexas78744
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Katherine Sides (PRINCIPAL_INVESTIGATOR)

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