NCT05118958

Phase 1 Crossover Study in Healthy Subjects to Evaluate the PK Profile of KVD824 Following Single and Multiple Doses of Modified Release (MR) Formulations

A Multiple Part, Phase 1 Crossover Study in Healthy Subjects to Evaluate the Pharmacokinetic (PK) Profile of KVD824 Following Single and Multiple Doses of Novel KVD824 Modified Release (MR) Formulations Compared to a Reference KVD824 Immediate Release (IR) Formulation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: KalVista Pharmaceuticals, Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Hereditary Angioedema

Interventions

Type	Name	Description
DRUG	KVD824 Prototype 1 modified-release tablet	300 mg modified-release tablet
DRUG	KVD824 Prototype 2 modified-release tablet	300 mg modified-release tablet
DRUG	KVD824 Immediate-Release Capsule	300 mg immediate-release capsule
DRUG	Placebo to KVD824 Prototype 1	Placebo to 300 mg KVD824 Prototype 1 modified-release tablet
DRUG	KVD824 Prototype 3 modified-release tablet	300 mg modified-release tablet

Timeline

• Start date: 2020-05-19
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2021-11-12
• Last updated: 2021-11-12

Locations

1 site across 1 country: United Kingdom