Cabotegravir sodium (Oral Lead In)
DrugCAB 30 mg tablets administered orally.
NCT Number: NCT04484337
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.
Looking for future studies?
Notify Me18 year–50 year
All sexes
Interventional
Phase 1
GSK Investigational Site, Auckland, New Zealand
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CAB 30 mg tablets administered orally.
CAB 400 mg/mL administered intramascularly or subcutaneously.
CAB 200 mg/mL administered intramascularly or subcutaneously.
NSAID applied topically.
Steroid medication applied topically.
Placebo for NSAID applied topically.
rHuPH20 administered subcutaneously.
Placebo for steroid applied topically.
Time frame: Injection 1 - Day 1 to Week 4
Blood samples were collected for Pharmacokinetic (PK) analysis of CAB. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Time frame: Injection 2 - Day 1 to Week 52 follow-up
Blood samples were collected for PK analysis of CAB. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Time frame: Injection 1 - Day 1 to Week 12
Blood samples were collected for PK analysis of CAB after intramuscular (IM) administration. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Time frame: Injection 2 - Day 1 to Week 52 follow-up
Blood samples were collected for PK analysis of CAB after intramuscular (IM) administration. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Time frame: Injection 2 - Week 4 to Week 52 follow-up
Blood samples were collected at indicated time points. The PK parameters were calculated by non-compartmental analysis. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Time frame: Injection 2 - Week 12 to Week 52 follow-up
Blood samples were collected for PK analysis of CAB after intramuscular (IM) administration. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Time frame: Injection 2 - Week 4 to Week 52 follow-up
KALA defined as the rate at which a drug is absorbed into the bloodstream after administration. Blood samples were collected at indicated time points. PK parameters were determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Time frame: Injection 2 - Week 12 to Week 52 follow-up
KALA defined as the rate at which a drug is absorbed into the bloodstream after administration. Blood samples were collected at indicated time points. PK parameters were determined using standard non-compartmental methods. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Time frame: Injection 1 - Day 1 to Week 4
Blood samples were collected for PK analysis of CAB. Ctau is the trough concentration at the end of the dosing interval. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze and compare the data for participants that received CAB 400 mg/ml formulation in this study, and historical data for CAB 200 mg/mL in ATLAS /FLAIR studies.
Time frame: Injection 2 - Day 1 to Week 4
Blood samples were collected for PK analysis of CAB. Ctau is the trough concentration at the end of the dosing interval. PK parameter was determined using standard non-compartmental methods. The objective of this endpoint was to analyze and compare the data for participants that received CAB 400 mg/ml formulation in this study, and historical data for CAB 200 mg/mL in ATLAS /FLAIR studies.
Time frame: Injection 1 - Day 1 to Week 12
Blood samples were collected for PK analysis of CAB. PK parameter was determined using standard non-compartmental methods. Ctau is the trough concentration at the end of the dosing interval. Ctau was expressed as geometric mean. For ATLAS /FLAIR: Historical data of CAB200 group, the geometric mean following dose normalization to 800mg was presented. The objective of this endpoint was to analyze and compare the data for participants that received CAB 400 mg/ml formulation in this study, and historical data for CAB 200 mg/mL in ATLAS /FLAIR and ECLAIRE studies.
Time frame: Injection 1 - Day 1 to Week 4
Blood samples were collected for PK analysis of CAB. The PK parameters were calculated by non-compartmental analysis. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Time frame: Injection 2 - Day 1 to Week 4
Blood samples were collected for PK analysis of CAB. The PK parameters were calculated by non-compartmental analysis. The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Time frame: Injection 1 - Day 1 to Week 4
The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Time frame: Injection 2 - Day 1 to Week 4
The objective of this endpoint was to analyze data for participants that received CAB 400 mg/ml formulation, therefore results are presented for those groups only.
Time frame: From Injection 1 day 1 up to 52 weeks follow-up
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product.
The objective of this analysis is to present the data for participants that received at least an intramuscular or subcutaneous study injection of CAB 400 mg/mL or CAB 200 mg/mL with rHuPH20 formulation.
Time frame: From Injection 1 day 1 up to 52 weeks follow-up
Blood samples were collected at indicated timepoints to analyze the liver biochemistry parameters: alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), Bilirubin and Direct Bilirubin.
The objective of this analysis is to present the data for participants that received at least an intramuscular or subcutaneous study injection of CAB 400 mg/mL or CAB 200 mg/mL with rHuPH20 formulation.
Time frame: Up to Day 29
Blood samples were collected for PK analysis of CAB. PK parameter was determined using standard non-compartmental methods.
Time frame: Up to Day 29
Blood samples were collected for PK analysis of CAB. PK parameter was determined using standard non-compartmental methods.
Time frame: Up to Day 29
Blood samples were collected for PK analysis of CAB after subcutaneous administration. The PK parameters were calculated by non-compartmental analysis.
Time frame: At 24 hours
Time frame: Up to 24 hours on day 29 (Oral lead in phase)
Time frame: Injection 1 - Day 1 to Week 52 follow-up
Blood samples were collected for PK analysis of CAB after subcutaneous administration. PK parameter was determined using standard non-compartmental methods.
Time frame: Injection 1 - Day 1 to Week 52 follow-up
Blood samples were collected for PK analysis of CAB after subcutaneous administration. PK parameter was determined using standard non-compartmental methods.
Time frame: Injection 1 - Day 1 to Week 52 follow-up
Blood samples were collected for PK analysis of CAB after subcutaneous administration. PK parameters were determined using standard non-compartmental methods.
Time frame: Injection 1 - Day 1 to Week 52 follow-up
Blood samples were collected for PK analysis of CAB after subcutaneous administration. Ctau is the trough concentration at the end of the dosing interval. PK parameter was determined using standard non-compartmental methods. Ctau was expressed as geometric mean. For ATLAS /FLAIR: Historical data of CAB200 group, the geometric mean following dose normalization to 400mg was presented.
Time frame: Injection 1 - Day 1 to Week 52 follow-up
Blood samples were collected for PK analysis of CAB after subcutaneous administration. The PK parameters were calculated by non-compartmental analysis.
Time frame: Injection 1 - Day 1 to Week 52 follow-up
KALA defined as the rate at which a drug is absorbed into the bloodstream after administration. Blood samples were collected for PK analysis of CAB after subcutaneous administration. PK parameters were determined using standard non-compartmental methods.
ViiV Healthcare
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT03048422
Blood-Borne Infections, Communicable Diseases
Jacksonville, Florida, United States
View Trial DetailsNCT05388474
Blood-Borne Infections, Communicable Diseases
Los Angeles, California, United States
View Trial DetailsNCT03284710
Blood-Borne Infections, Communicable Diseases
Maputo, Mozambique
View Trial DetailsNCT02591420
Blood-Borne Infections, Communicable Diseases
Kericho, Kenya
View Trial Details