Status:
COMPLETED
A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 (Sebetralstat) in Healthy Volunteers
Lead Sponsor:
KalVista Pharmaceuticals, Ltd.
Conditions:
Hereditary Angioedema
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
A safety, tolerability, pharmacokinetic and food effect study of KVD900 in healthy volunteers.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2018
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04349800
Start Date
January 4 2018
End Date
September 10 2018
Last Update
April 29 2025
Active Locations (1)
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1
KalVista Investigative Site
Wales, United Kingdom