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

Hereditary Angioedema Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of KVD900 Followed by Crossover Sub-studies of KVD900 Formulations, and Food Effect in Healthy Male Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04349800
• Other study ID #: KVD900-101
• Status: Completed
• Phase: Phase 1
• Start date: January 4, 2018
• Est. completion date: September 10, 2018

Study information

• Verified date: April 2020
• Source: KalVista Pharmaceuticals, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: September 10, 2018
• Est. primary completion date: September 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema

Intervention

Drug:
• KVD900
Active
• Placebo to KVD900
Placebo

Locations

Country	Name	City	State
United Kingdom	KalVista Investigative Site	Wales

Sponsors (1)

Lead Sponsor	Collaborator
KalVista Pharmaceuticals, Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Subjects with Adverse Events		Change from pre-dose to last visit, 5-7 days post dose.
Primary	Number of Subjects with Serious Adverse Events		Change from pre-dose to last visit, 5-7 days post dose.
Primary	Number of participants with clinically significant changes in laboratory assessments		Throughout study until last visit, 5-7 days post dose.
Primary	Number of participants with clinically significant changes in vital signs		Throughout study until last visit, 5-7 days post dose.
Primary	Number of participants with clinically significant changes in electrocardiogram (ECG) measurements		Throughout study until last visit, 5-7 days post dose.
Secondary	Pharmacokinetics - Cmax	Derived from time-concentration plasma levels of KVD900	Up to 48 hours post dose
Secondary	Pharmacokinetics - AUC0-t	Derived from time-concentration plasma levels of KVD900	Up to 48 hours post dose
Secondary	Pharmacokinetics - AUC0-24	Derived from time-concentration plasma levels of KVD900	Up to 24 hours post dose
Secondary	Pharmacokinetics - AUC0-inf	Derived from time-concentration plasma levels of KVD900	Up to 48 hours post dose
Secondary	Pharmacokinetics - food effect (Part C only)	90% confidence intervals of the ratios for AUC0-t and Cmax with and without food lie in the range 80-125	Up to 24 hours post dose
Secondary	Pharmacokinetics - formulation bridge - relative bioavailability (Part B only)	90% confidence intervals of the ratios for AUC0-t and Cmax between the two dosages lie in the range 80-125	Up to 24 hours post dose