This is an active control, randomized study to investigate the safety, tolerability and PK of repeat dose administration of long-acting CAB 400 mg/mL formulation intramuscular (IM) (gluteus medius and vastus lateralis) and subcutaneous (SC) (abdominal) injections in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
138
CAB will be available as 30 mg tablets for oral administration.
CAB 400 mg/mL will be available for administration by IM injection or SC Injection.
CAB 200 mg/mL will be available for administration by IM injection or SC Injection.
GSK Investigational Site
Orlando, Florida, United States
GSK Investigational Site
Las Vegas, Nevada, United States
GSK Investigational Site
Berlin, New Jersey, United States
GSK Investigational Site
Austin, Texas, United States
Maximum observed Plasma concentration (Cmax) for cabotegravir (Part 1 Injection 1)
Time frame: Injection 1 Day 1 to Injection 1 Week 4
Cmax for cabotegravir (Part 1 Injection 2)
Time frame: Injection 2 Day 1 to Week 52 follow-up
Cmax for cabotegravir (Part 2 Injection 1)
Time frame: Injection 1 Day 1 to Injection 1 Week 12
Cmax for cabotegravir (Part 2 Injection 2)
Time frame: Injection 2 Day 1 to Week 52 follow-up
Time of maximum observed plasma concentration (Tmax) for cabotegravir (Part 1 Injection 1)
Time frame: Injection 1 Day 1 to Injection 1 Week 4
Tmax for cabotegravir (Part 1 Injection 2)
Time frame: Injection 2 Day 1 to Week 52 follow-up
Tmax for cabotegravir (Part 2 Injection 1)
Time frame: Injection 1 Day 1 to Injection 1 Week 12
Tmax for cabotegravir (Part 2 Injection 2)
Time frame: Injection 2 Day 1 to Week 52 follow-up
Area under the concentration - time curve from time zero to last quantifiable time point (AUC[0-t]) for cabotegravir (Part 1 Injection 1)
Time frame: Injection 1 Day 1 to Injection 1 Week 4
AUC(0-t) for cabotegravir (Part 1 Injection 2)
Time frame: Injection 2 Day 1 to Injection 2 Week 4
AUC(0-t) for cabotegravir (Part 2 Injection 1)
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Non-steroidal anti-inflammatory drug will be available for topical application
Steroid will be available for topical application
Placebo creams/gels will be available for topical application
rHuPH20 will be available for administration by SC Injection
GSK Investigational Site
Auckland, New Zealand
Time frame: Injection 1 Day 1 to Injection 1 Week 12
AUC(0-t) for cabotegravir (Part 2 Injection 2)
Time frame: Injection 2 Day 1 to Injection 2 Week 12
Trough concentrations (Ctau) for cabotegravir (Part 1 Injection 1)
Time frame: Injection 1 Day 1 to Injection 1 Week 4
Ctau for cabotegravir (Part 1 Injection 2)
Time frame: Injection 2 Day 1 to Injection 2 Week 4
Ctau for cabotegravir (Part 2 Injection 1)
Time frame: Injection 1 Day 1 to Injection 1 Week 12
Ctau for cabotegravir (Part 2 Injection 2)
Time frame: Injection 2 Day 1 to Injection 2 Week 12
Apparent terminal phase half-life (T1/2) for cabotegravir (Part 1 Injection 2)
Time frame: Injection 2 Week 4 to Week 52 follow-up
T1/2 for cabotegravir (Part 2 Injection 2)
Time frame: Injection 2 Week 12 to Week 52 follow-up
Absorption rate constant (KALA) for cabotegravir (Part 1 Injection 2)
Time frame: Injection 2 Week 4 to Week 52 follow-up
KALA for cabotegravir (Part 2 Injection 2)
Time frame: Injection 2 Week 12 to Week 52 follow-up
Geometric mean ratio of plasma Ctau of CAB for Cohorts 1,2,3,4, 4b & 4h at Week4 (Part 1 Injection 1) compared to historical data of CAB 200 mg/mL IM (gluteus medius) (Week 8 Ctau following first injection at Week 4 in ATLAS [201585]/FLAIR [201584]Study)
Time frame: At Injection 1 Week 4
Geometric mean ratio of plasma Ctau of CAB for Cohorts 1,2,3,4, 4b at Week 4 (Part 1 Injection 2) compared to historical data of CAB 200 mg/mL IM (gluteus medius) (Week 12 Ctau following first injection at Week 8 in ATLAS [201585]/FLAIR [201584]Study)
Time frame: At Injection 2 Week 4
Geometric mean ratio of plasma Ctau of CAB for Cohorts 5 and 6 at Week 12(Part 2 Injection 1) compared to historical data of CAB 200 mg/mL IM (gluteus medius) (Week 8 Ctau following first injection at Week 4 in ATLAS [201585]/FLAIR [201584]Study)
Time frame: At Injection 1 Week 12
Geometric mean ratio of plasma trough concentration (Ctau) of cabotegravir at Week 4 (Part 1 Injection 1) for each pairwise comparison between Cohorts 1, 2, 3, 4, 4b and 4h
Time frame: At Injection 1 Week 4
Geometric mean ratio of plasma trough concentration (Ctau) of cabotegravir at Week 4 (Part 1 Injection 2) for each pairwise comparison between Cohorts 1, 2, 3, 4 and 4b
Time frame: At Injection 2 Week 4
Geometric mean ratio of Plasma AUC(0-t) of cabotegravir at Week 4 (Part 1 Injection 1) for each pairwise comparison between Cohorts 1, 2, 3, 4, 4b and 4h
Time frame: At Injection 1 Week 4
Geometric mean ratio of Plasma Cmax of cabotegravir at Week 4 (Part 1 Injection 2) for each pairwise comparison between Cohorts 1, 2, 3, 4 and 4b
Time frame: At Injection 2 Week 4
Geometric mean ratio of Plasma Cmax of cabotegravir at Week 4 (Part 1 Injection 1) for each pairwise comparison between Cohorts 1, 2, 3, 4, 4b and 4h
Time frame: At Injection 1 Week 4
Geometric mean ratio of Plasma AUC(0-t) of cabotegravir at Week 4 (Part 1 Injection 2) for each pairwise comparison between Cohorts 1, 2, 3, 4 and 4b
Time frame: At Injection 2 Week 4
Parts 1 and 2: Number of participants with adverse events (AEs)
Time frame: Up to 52 weeks follow-up
Number of participants with liver biochemistry abnormalities
Time frame: Up to 52 weeks follow-up
Cmax for cabotegravir following oral 30 mg administration
Time frame: Up to Day 29
Tmax for cabotegravir following oral 30 mg administration
Time frame: Up to Day 29
AUC(0-t) for cabotegravir following oral 30 mg administration
Time frame: Up to Day 29
Concentration at 24 hours (C24) for cabotegravir following oral 30 mg administration
Time frame: At 24 hours
Ctau for cabotegravir at Day 29 following oral 30 mg administration
Time frame: Up to Day 29
Cmax of cabotegravir for cohort 4h
Time frame: Injection 1 Day 1 to Week 52 follow-up
Tmax of cabotegravir for cohort 4h
Time frame: Injection 1 Day 1 to Week 52 follow-up
AUC(0-t) of cabotegravir for cohort 4h
Time frame: Injection 1 Day 1 to Week 52 follow-up
Ctau of cabotegravir for cohort 4h
Time frame: Injection 1 Day 1 to Week 52 follow-up
T1/2 of cabotegravir for cohort 4h
Time frame: Injection 1 Day 1 to Week 52 follow-up
KALA of cabotegravir for cohort 4h
Time frame: Injection 1 Day 1 to Week 52 follow-up