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Cabotegravir 200 mg/mLWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug595 Cabotegravir 400 mg/mL Wiki 1.00
drug596 Cabotegravir sodium (Oral Lead In) Wiki 1.00

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D015658 HIV Infections NIH 0.32

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Phase 1, Two-part, Double-blind, Active-control, Randomized Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Repeat-Dose Cabotegravir (CAB 400 mg/mL Formulation) Long-Acting Injection Following Subcutaneous or Intramuscular Administration in Healthy Adult Participants

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. The study will assess the relative bioavailability of the CAB 400 mg/mL formulation administered by IM (vastus lateralis) and SC routes compared to the CAB 400 mg/mL administered via IM (gluteus medius) and also compared with historical data of CAB 200 mg/mL formulation administered via IM (gluteus medius). This is a two part study and will consist of a screening period, a 28-day oral lead-in with CAB 30 mg once daily, a 7 to 14-day washout period, an injection phase (up to Week 8 in Part 1 and up to Week 24 in Part 2) and a follow-up phase up to Week 52 post last injection.

NCT04484337 HIV Infections Drug: Cabotegravir sodium (Oral Lead In) Drug: Cabotegravir 400 mg/mL Drug: Cabotegravir 200 mg/mL
MeSH:HIV Infections

Primary Outcomes

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.

Measure: Maximum observed Plasma concentration (Cmax) for cabotegravir (Part 1 Injection 1)

Time: Pre-dose and at 1, 2, 8 hours (Day 1), 24 hours (Day 2), Day 3, 5, 6, 7, 8, 10, 14 or 15, 17 and 22

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.

Measure: Cmax for cabotegravir (Part 1 Injection 2)

Time: Pre-dose, 1, 2, 8 hours (Day 28/Week 4), 24 hours (Day 29), Day 30, 32, 33, 34, 35, 37, 41, 42, 44, 49, 56 (Week 8), Week 12, 16, 24, 32, 40, 48 and 52

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.

Measure: Cmax for cabotegravir (Part 2 Injection 1)

Time: Pre-dose, 1, 2, 8 hours (Day 1), 24 hours (Day 2), Day 3, 5, 6, 7, 8, 10, 14 or 15, 17, 22, Week 4, 6, 8 and 10

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.

Measure: Cmax for cabotegravir (Part 2 Injection 2)

Time: Pre-dose, 1, 2, 8 hours (Week 12-Day 1), 24 hours (Week 12-Day 2), Week 12-Day 3, Week 12-Day 5, Week 12-Day 6, Week 12-Day 7, Week 12-Day 8, Week 12-Day 10, Week 12-Day 14or15, Week 12-Day 17, Week 12-Day 22, Week 16, 18, 20, 22, 24, 36, 52 and 64

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.

Measure: Time of maximum observed plasma concentration (Tmax) for cabotegravir (Part 1 Injection 1)

Time: Pre-dose, 1, 2, 8 hours (Day 1), 24 hours (Day 2), Day 3, 5, 6, 7, 8, 10, 14 or 15, 17 and 22

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.

Measure: Tmax for cabotegravir (Part 1 Injection 2)

Time: Pre-dose, 1, 2, 8 hours (Day 28/Week 4), 24 hours (Day 29), Day 30, 32, 33, 34, 35, 37, 41, 42, 44, 49, 56 (Week 8), Week 12, 16, 24, 32, 40, 48 and 52

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.

Measure: Tmax for cabotegravir (Part 2 Injection 1)

Time: Pre-dose, 1, 2, 8 hours (Day 1), 24 hours (Day 2), Day 3, 5, 6, 7, 8, 10, 14 or 15, 17, 22, Week 4, 6, 8 and 10

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.

Measure: Tmax for cabotegravir (Part 2 Injection 2)

Time: Pre-dose, 1, 2, 8 hours (Week 12-Day 1), 24 hours (Week 12-Day 2), Week 12-Day 3, Week 12-Day 5, Week 12-Day 6, Week 12-Day 7, Week 12-Day 8, Week 12-Day 10, Week 12-Day 14or15, Week 12-Day 17, Week 12-Day 22, Week 16, 18, 20, 22, 24, 36, 52 and 64

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.

Measure: Area under the concentration - time curve from time zero to last quantifiable time point (AUC[0-t]) for cabotegravir (Part 1 Injection 1)

Time: Pre-dose and at 1, 2, 8 hours (Day 1), 24 hours (Day 2), Day 3, 5, 6, 7, 8, 10, 14 or 15, 17 and 22

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.

Measure: AUC(0-t) for cabotegravir (Part 1 Injection 2)

Time: Pre-dose, 1, 2, 8 hours (Day 28/Week 4), 24 hours (Day 29), Day 30, 32, 33, 34, 35, 37, 41, 42, 44, 49, 56 (Week 8), Week 12, 16, 24, 32, 40, 48 and 52

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.

Measure: AUC(0-t) for cabotegravir (Part 2 Injection 1)

Time: Pre-dose, 1, 2, 8 hours (Day 1), 24 hours (Day 2), Day 3, 5, 6, 7, 8, 10, 14 or 15, 17, 22, Week 4, 6, 8 and 10

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.

Measure: AUC(0-t) for cabotegravir (Part 2 Injection 2)

Time: Pre-dose, 1, 2, 8 hours (Week 12-Day 1), 24 hours (Week 12-Day 2), Week 12-Day 3, Week 12-Day 5, Week 12-Day 6, Week 12-Day 7, Week 12-Day 8, Week 12-Day 10, Week 12-Day 14or15, Week 12-Day 17, Week 12-Day 22, Week 16, 18, 20, 22, 24, 36, 52 and 64

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.

Measure: Trough concentrations (Ctau) for cabotegravir (Part 1 Injection 1)

Time: Pre-dose and at 1, 2, 8 hours (Day 1), 24 hours (Day 2), Day 3, 5, 6, 7, 8, 10, 14 or 15, 17 and 22

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.

Measure: Ctau for cabotegravir (Part 1 Injection 2)

Time: Pre-dose, 1, 2, 8 hours (Day 28/Week 4), 24 hours (Day 29), Day 30, 32, 33, 34, 35, 37, 41, 42, 44, 49, 56 (Week 8), Week 12, 16, 24, 32, 40, 48 and 52

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.

Measure: Ctau for cabotegravir (Part 2 Injection 1)

Time: Pre-dose, 1, 2, 8 hours (Day 1), 24 hours (Day 2), Day 3, 5, 6, 7, 8, 10, 14 or 15, 17, 22, Week 4, 6, 8 and 10

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.

Measure: Ctau for cabotegravir (Part 2 Injection 2)

Time: Pre-dose, 1, 2, 8 hours (Week 12-Day 1), 24 hours (Week 12-Day 2), Week 12-Day 3, Week 12-Day 5, Week 12-Day 6, Week 12-Day 7, Week 12-Day 8, Week 12-Day 10, Week 12-Day 14or15, Week 12-Day 17, Week 12-Day 22, Week 16, 18, 20, 22, 24, 36, 52 and 64

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.

Measure: Apparent terminal phase half-life (T½) for cabotegravir (Part 1 Injection 2)

Time: Pre-dose, 1, 2, 8 hours (Day 28/Week 4), 24 hours (Day 29), Day 30, 32, 33, 34, 35, 37, 41, 42, 44, 49, 56 (Week 8), Week 12, 16, 24, 32, 40, 48 and 52

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.

Measure: T½ for cabotegravir (Part 2 Injection 2)

Time: Pre-dose, 1, 2, 8 hours (Week 12-Day 1), 24 hours (Week 12-Day 2), Week 12-Day 3, Week 12-Day 5, Week 12-Day 6, Week 12-Day 7, Week 12-Day 8, Week 12-Day 10, Week 12-Day 14or15, Week 12-Day 17, Week 12-Day 22, Week 16, 18, 20, 22, 24, 36, 52 and 64

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.

Measure: Absorption rate constant (KALA) for cabotegravir (Part 1 Injection 2)

Time: Pre-dose, 1, 2, 8 hours (Day 28/Week 4), 24 hours (Day 29), Day 30, 32, 33, 34, 35, 37, 41, 42, 44, 49, 56 (Week 8), Week 12, 16, 24, 32, 40, 48 and 52

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir.

Measure: KALA for cabotegravir (Part 2 Injection 2)

Time: Pre-dose, 1, 2, 8 hours (Week 12-Day 1), 24 hours (Week 12-Day 2), Week 12-Day 3, Week 12-Day 5, Week 12-Day 6, Week 12-Day 7, Week 12-Day 8, Week 12-Day 10, Week 12-Day 14or15, Week 12-Day 17, Week 12-Day 22, Week 16, 18, 20, 22, 24, 36, 52 and 64

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir. Geometric mean ratio of plasma Ctau of cabotegravir will be calculated for Cohorts 1, 2, 3, and 4 at Week 4 compared to historical CAB 200 mg/ml data (Week 8 Ctau following first injection at Week 4b in ATLAS [Study 201585]/FLAIR [Study 201584]).

Measure: Geometric mean ratio of plasma trough concentrations (Ctau) of cabotegravir for Cohorts 1, 2, 3, and 4 at Week 4 compared to historical CAB data at Week 8

Time: Pre-dose,1,2,8 hours (Day28/Week4) and at Week 4

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir. Geometric mean ratio of plasma trough concentrations (Ctau) of cabotegravir will be calculated for Cohorts 1, 2, 3, and 4 at Week 8 compared to historical CAB 200 mg/ml data (Week 12 Ctau following second injection at Week 8 in ATLAS [Study 201585]/FLAIR [Study 201584]).

Measure: Geometric mean ratio of plasma Ctau of cabotegravir for Cohorts 1, 2, 3, and 4 at Week 8 compared to historical CAB data at Week 12

Time: At Week 8 and at Week 12

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir. Geometric mean ratio of plasma Ctau of cabotegravir will be calculated for Cohorts 5 and 6 at Week 12 compared to historical CAB 200 mg/ml data (Week 8 Ctau following first injection at Week 4b in ATLAS [Study 201585]/FLAIR [Study 201584]).

Measure: Geometric mean ratio of plasma Ctau of cabotegravir for Cohorts 5 and 6 at Week 12 compared to historical CAB 200 data at Week 8

Time: At Week 12 and at Week 8

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir. Geometric mean ratio will be calculated by pair-wise comparisons between cohorts 1, 2, 3, and 4.

Measure: Geometric mean ratio of Plasma AUC(0-t) of cabotegravir

Time: Pre-dose and at 1,2,8hours (Day 1), 24 hours (Day 2), Day 3,5,6,7,8,10,14 or 15,17 and 22(injection 1); Pre-dose, 1,2,8hours (Day 28/Week 4), 24hours (Day 29), Day 30,32,33,34,35,37,41,42,44,49,56 (Week 8), Week 12,16,24,32,40,48 and 52 (Injection 2)

Description: Blood samples will be collected at indicated time points for pharmacokinetic analysis of cabotegravir. Geometric mean ratio will be calculated by pair-wise comparisons between cohorts 1, 2, 3, and 4.

Measure: Geometric mean ratio of Cmax of cabotegravir

Time: Pre-dose, 1,2,8 hours(Day1), 24hours (Day2), Day3,5,6,7,8,10,14 or 15,17 and 22(injection 1); Pre-dose,1,2,8 hours(Day28/Week4), 24 hours(Day29), Day 30, 32, 33, 34, 35, 37, 41, 42, 44, 49, 56 (Week8), Week12, 16, 24, 32, 40, 48 and 52 (Injection 2)

Secondary Outcomes

Description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention

Measure: Number of participants with adverse events (AEs) (Part 1)

Time: Up to 52 weeks post last injection

Description: An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention

Measure: Number of participants with AEs (Part 2)

Time: Up to 52 weeks post last injection

Description: PIN questionnaire contains 21 items that are grouped into 4 dimensions ("Acceptance of ISRs", "Bother of ISRs", "Sleep" and "Leg movement" and 5 individual items. Scores range from 1 to 5, and questions are phrased in such a way as to ensure that 1 always equated with the most favorable perception of injection, and 5 the most unfavorable. PIN does not produce a total score.

Measure: Number of participants with acceptance of injection site reactions (ISRs) as assessed by Perception of Injection (PIN) questionnaire

Time: At Day 8 post injection

Description: Participants will be asked to rate their maximum level of pain since last assessment with the NRS on a scale of 0 (No pain) and 10 (extreme pain).

Measure: Number of participants with maximum level of pain assessed using Numeric Rating Scale (NRS)

Time: At Days 1, 2, 5, 8 post each injection

Description: Participants with liver biochemistry abnormalities will be assessed.

Measure: Number of participants with liver biochemistry abnormalities

Time: Up to 52 weeks post last injection

No related HPO nodes (Using clinical trials)