Clinical Trials Logo

Clinical Trial Summary

This is a 3 part, phase 1 crossover study in healthy subjects to evaluate the pharmacokinetic profile of KVD824 following single and multiple doses of novel KVD824 modified-release formulations compared with a reference KVD824 immediate release formulation.


Clinical Trial Description

Part 1 of the study was a single-centre, open-label, non-randomised, 6-period crossover study designed to investigate the PK and safety of KVD824 MR prototype formulations (with or without an additional KVD824 IR capsule) compared to a reference KVD824 IR capsule formulation in healthy male and female subjects. Part 2 was an optional part designed to investigate the PK and safety of a selected KVD824 MR prototype tablet formulation (with or without an additional KVD824 IR capsule) in healthy male and female subjects in both the fed and fasted state. Note: this Part was not conducted as sufficient information on food effect was collected in the other Parts of the study. Part 3 was a single-centre, randomised, double-blind, placebo-controlled, multiple dose group study to investigate the PK and safety of a selected KVD824 MR prototype tablet formulation (with or without an additional KVD824 IR capsule) in healthy male and female subjects. Part 3 started following completion of Part 1. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05118958
Study type Interventional
Source KalVista Pharmaceuticals, Ltd.
Contact
Status Completed
Phase Phase 1
Start date May 19, 2020
Completion date December 1, 2020

See also
  Status Clinical Trial Phase
Completed NCT00997204 - EASSI - Evaluation of the Safety of Self-Administration With Icatibant Phase 3
Completed NCT00438815 - Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks Phase 3
Completed NCT00748202 - Berinert P Study of Subcutaneous Versus Intravenous Administration Phase 3
Completed NCT01426763 - A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase Phase 2
Recruiting NCT04091113 - Hereditary Angioedema Kininogen Assay
Completed NCT00432510 - Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects Phase 1
Completed NCT04030598 - A Study to Assess the Clinical Efficacy of IONIS-PKK-LRx in Participants With Hereditary Angioedema Phase 2
Completed NCT03712228 - A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE) Phase 2
Not yet recruiting NCT04957641 - A Study of the Burden of Illness and Treatment Patterns in Teenagers and Adults With Hereditary Angioedema
Recruiting NCT05047185 - Dose-ranging Study of Oral PHA-022121 for Prophylaxis Against Angioedema Attacks in Patients With Hereditary Angioedema Type I or Type II Phase 2
Recruiting NCT05121376 - A Gene Therapy Study of BMN 331 in Subjects With Hereditary Angioedema Phase 1/Phase 2
Completed NCT02303626 - 12-Week Safety and Efficacy Study of BCX4161 as an Oral Prophylaxis Against HAE Attacks Phase 2/Phase 3
Not yet recruiting NCT02159430 - Hereditary AngioEdema, Neurobiology and Psychopathology N/A
Completed NCT01984788 - Safety and Efficacy of Oral BCX4161 as a Prophylactic Treatment for HAE Phase 2
Recruiting NCT05120830 - NTLA-2002 in Adults With Hereditary Angioedema (HAE) Phase 1/Phase 2
Recruiting NCT04888650 - Assessment of the State of Health, Quality of Life and Expectations of Patients With Hereditary Angioedema
Completed NCT02448264 - First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BCX7353 in Healthy Western and Japanese Volunteers Phase 1
Recruiting NCT04739059 - Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks Phase 3
Completed NCT02819102 - An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates Phase 1
Completed NCT01679912 - A Call Center During HAE Attacks (SOS HAE) Phase 4