Hereditary Angioedema
Conditions
Keywords
Sebetralstat
Brief summary
A safety, tolerability, pharmacokinetic and food effect study of KVD900 in healthy volunteers.
Interventions
DRUGKVD900
Active
DRUGPlacebo to KVD900
Placebo
Sponsors
KalVista Pharmaceuticals, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Adverse Events | Change from pre-dose to 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics - Cmax | Up to 48 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 |
| Pharmacokinetics - AUC0-24 | Up to 24 hours post dose | Derived from time-concentration plasma levels of KVD900 |
| 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 |
Countries
United Kingdom
Outcome results
None listed