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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug825 | Cabotegravir sodium (Oral Lead In) Wiki | 1.00 |
| drug821 | Cabotegravir 400 mg/mL Wiki | 1.00 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
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.
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 22Description: 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 52Description: 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 10Description: 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 64Description: 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 22Description: 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 52Description: 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 10Description: 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 64Description: 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 22Description: 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 52Description: 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 10Description: 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 64Description: 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 22Description: 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 52Description: 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 10Description: 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 64Description: 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 52Description: 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 64Description: 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 52Description: 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 64Description: 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 4Description: 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 12Description: 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 8Description: 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)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 injectionDescription: 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 injectionDescription: 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 injectionDescription: 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 injectionDescription: Participants with liver biochemistry abnormalities will be assessed.
Measure: Number of participants with liver biochemistry abnormalities Time: Up to 52 weeks post last injectionAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports