A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 in Healthy Volunteers

Phase 1

Completed

• Conditions: Hereditary Angioedema
• Interventions: Drug: KVD900; Drug: Placebo to KVD900

• Registration Number: NCT04349800
• Lead Sponsor: KalVista Pharmaceuticals, Ltd.

Brief Summary

A safety, tolerability, pharmacokinetic and food effect study of KVD900 in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-04
• Primary Completion: 2018-09-10
• Study Completion: 2018-09-10
• Study First Submitted: 2020-03-09
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-14
• Last Update Submitted: 2020-04-14
• Study First Posted: 2020-04-16
• Last Update Posted: 2020-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 84

Inclusion Criteria

• Healthy male subjects between 18 and 55 years of age.
• Healthy subjects as determined by past medical history and as judged by the Chief Investigator or designee.
• Male subject willing to use a highly effective method of contraception.
• Subject with a body mass index (BMI) of 18-32 kg/m2.
• Subject with no clinically significant history of previous allergy or sensitivity to KVD900 or any of the excipients contained within the investigational medicinal product (IMP).
• Subject with no clinically significant abnormal serum biochemistry, haematology, clotting profiles, and urine examination values within 28 days before the first dose of IMP.
• Subject with a negative urinary drugs of abuse screen, determined within 28 days before the first dose of IMP
• Subject with negative human immunodeficiency virus (HIV) and hepatitis B surface antigen (Hep B) and hepatitis C virus antibody (Hep C) results.
• Subject with no clinically significant abnormalities in 12-lead electrocardiogram
• Subjects must not donate sperm from first dose until at least 3 months after last dose of IMP.
• Subjects without any special food restrictions that would hinder ability to consume the high fat breakfast provided during study Part C; such as lactose intolerance , vegan, low-fat, low sodium, etc.
• Subjects with no known allergy or sensitivity to lactose and/or any additional excipients contained in IMP.
• Subject must be available to complete the study (including all follow up visits).
• Subject must satisfy the Chief Investigator or designee about their fitness to participate in the study.
• Subject must provide written informed consent to participate in the study.

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Exclusion Criteria

• A clinically significant history of gastrointestinal disorder likely to influence IMP absorption.
• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements .
• Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular (no history of syncope or vasovagal events), or metabolic dysfunction.
• Subjects with a history of clotting abnormalities.
• A clinically significant history of drug or alcohol abuse in the last 5 years.
• Users of nicotine products i.e., current smokers or ex-smokers who have smoked within the 6 months prior to dosing with the study medication or users of cigarette replacements.
• Inability to communicate well with Investigators.
• Participation in a New Chemical Entity clinical study within the previous 3 months or a marketed drug clinical study within the 30 days before the first dose of IMP.
• Donation of 450 mL or more blood within the 3 months before the first dose of IMP.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single Ascending Dose - 10 mg	KVD900	-
Single Ascending Dose - 5 mg	KVD900	-
Single Ascending Dose - 10 mg	Placebo to KVD900	-
Single Ascending Dose - 20 mg	Placebo to KVD900	-
Single Ascending Dose - 160 mg	KVD900	-
Single Ascending Dose - 80 mg	Placebo to KVD900	-
Single Ascending Dose - 160 mg	Placebo to KVD900	-
Single Ascending Dose - 5 mg	Placebo to KVD900	-
Single Ascending Dose - 300 mg	Placebo to KVD900	-
Single Ascending Dose - 20 mg	KVD900	-
Single Ascending Dose - 600 mg	Placebo to KVD900	-
Food Effect	KVD900	-
Single Ascending Dose - 40 mg	KVD900	-
Single Ascending Dose - 40 mg	Placebo to KVD900	-
Single Ascending Dose - 80 mg	KVD900	-
Single Ascending Dose - 300 mg	KVD900	-
Single Ascending Dose - 600 mg	KVD900	-
Formulation Screen	KVD900	-

Primary Outcome Measures

Name	Time	Method
Number of participants with clinically significant changes in laboratory assessments	Throughout study until last visit, 5-7 days post dose.
Number of participants with clinically significant changes in vital signs	Throughout study until last visit, 5-7 days post dose.
Number of participants with clinically significant changes in electrocardiogram (ECG) measurements	Throughout study until last visit, 5-7 days post dose.
Number of Subjects with Serious Adverse Events	Change from pre-dose to last visit, 5-7 days post dose.
Number of Subjects with Adverse Events	Change from pre-dose to last visit, 5-7 days post dose.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics - AUC0-inf	Up to 48 hours post dose	Derived from time-concentration plasma levels of KVD900
Pharmacokinetics - food effect (Part C only)	Up to 24 hours post dose	90% confidence intervals of the ratios for AUC0-t and Cmax with and without food lie in the range 80-125
Pharmacokinetics - Cmax	Up to 48 hours post dose	Derived from time-concentration plasma levels of KVD900
Pharmacokinetics - AUC0-24	Up to 24 hours post dose	Derived from time-concentration plasma levels of KVD900
Pharmacokinetics - formulation bridge - relative bioavailability (Part B only)	Up to 24 hours post dose	90% confidence intervals of the ratios for AUC0-t and Cmax between the two dosages lie in the range 80-125
Pharmacokinetics - AUC0-t	Up to 48 hours post dose	Derived from time-concentration plasma levels of KVD900

Trial Locations

Locations (1)

KalVista Investigative Site; 🇬🇧 Wales, United Kingdom