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

NCT05118958 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2021-11-12

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • KalVista Pharmaceuticals, Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-19
Primary Completion
2020-12-01
Completion
2020-12-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05118958 on ClinicalTrials.gov