Hereditary AngioedemaPhase 1NCT05178355
A Single and Multiple Doses Safety, Tolerability, Pharmacokinetics and Food Effect Study of KVD824 in Healthy Volunteers
A Phase 1 study testing KVD824 in people with Hereditary Angioedema, run by KalVista Pharmaceuticals, Ltd. at 1 site in United Kingdom.
Trial summary
This is a 3 part phase 1, randomized, double-blind, placebo-controlled, study of the safety, tolerability, and pharmacokinetics of KVD824 following administration of single and multiple ascending oral doses; followed by a crossover food effect sub-study in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hereditary Angioedema
- What is being tested?
- KVD824
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 12 Feb 2019to 21 Jun 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 / deputy.
- Male subject willing to wear a condom and whose partner of child bearing potential uses a highly effective method of contraception (e.g. partner use of intrauterine device (IUD)) or an effective method of contraception, i.e., established method of contraception + condom, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from first dose until 3 months after last dose of IMP. Men whose partners are already pregnant must continue to use a condom during the trial and for three months thereafter.
- Subject with a body mass index (BMI) of 18-32 kg/m2.
- Subject with no clinically significant history of previous allergy / sensitivity to KVD824 or any of the excipients contained within the Investigational Medicinal Product.
- Subject with no clinically significant abnormal serum biochemistry, haematology, clotting profiles, and urine examination values within 28 days before the first dose of Investigational Medicinal Product.
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- Subject with a negative urinary drugs of abuse screen, determined within 28 days before the first dose of Investigational Medicinal Product (N.B. a positive result may be repeated at the Chief Investigator's discretion).
- 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 (QTcF ≤ 430 ms and PR interval 120-220 ms) determined within 28 days before first dose of Investigational Medicinal Product.
- Subject with no clinically significant abnormalities in vital signs (supine systolic (≤140 mmHg) and diastolic blood pressure (≤ 90 mmHg), pulse (≤ 100 bpm), oral temperature (≤ 37.5°C)) determined within 28 days before first dose of Investigational Medicinal Product.
- Subjects must not donate sperm from first dose until at least 3 months after last dose of Investigational Medicinal Product.
- Subjects without any special food restrictions that would hinder ability to consume gelatin (Part A and Part B placebo), or the high fat breakfast provided during study Part C; such as vegetarian, lactose intolerance, vegan, low-fat, low sodium, etc.
- Subjects with no known allergy or sensitivity to lactose and/or any additional excipients contained in Investigational Medicinal Product.
- Subject must be available to complete the study (including all follow up visits).
- Subject must satisfy the Chief Investigator / deputy about their fitness to participate in the study.
- Subject must provide written informed consent to participate in the study.
Who cannot join
- A clinically significant history of gastrointestinal disorder likely to influence Investigational Medicinal Product absorption.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 28 days or 5 half-lives (which ever is longer) prior to the first dose of Investigational Medicinal Product, unless in the opinion of the Chief Investigator the medication will not interfere with the study procedures or compromise subject safety.
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular 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 (e.g., e-cigarettes, nicotine patches or gums).
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- Inability to communicate well with Investigators (i.e., language problem, poor mental development or impaired cerebral function).
- 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 Investigational Medicinal Product. (Washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study).
- Donation of 450 mL or more blood within the 3 months before the first dose of Investigational Medicinal Product.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Doses Study of the Safety, Tolerability, and Pharmacokinetics of KVD824 Followed by Crossover Food Effect Sub-study in Healthy Volunteers
This is a 3 part phase 1, randomized, double-blind, placebo-controlled, study of the safety, tolerability, and pharmacokinetics of KVD824 following administration of single and multiple ascending oral doses; followed by a crossover food effect sub-study in healthy male volunteers.
Read the detailed description
Part A was a single-centre randomized, double blinded, placebo control to investigate the safety and tolerability of single ascending doses of KVD824 administered to healthy male volunteers.
Part B was a single centre, randomized, double blinded, placebo control to investigate the safety and tolerability of multiple ascending doses of KVD824 administered to healthy male volunteers.
Part C was a single-centre, open labelled to investigate the food effect.
- Conditions
- Hereditary Angioedema
- Being tested
- KVD824, Placebo to KVD824
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KVD824Drug
Active
Placebo to KVD824Drug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Part A - KVD824 - 10 mg | Experimental | 6 participants were administered10 mg of KVD824 in capsule form (1 x 10 mg capsule) on one occasion on Day 1. 2 participants received matching placebo. Receives: Drug: KVD824; Drug: Placebo to KVD824 |
| Part A - KVD824 - 20 mg | Experimental | 6 participants were administered 20mg of KVD824 in capsule form ( 2 x 10 mg capsules) on one occasion on Day 1. 2 participants received matching placebo. Receives: Drug: KVD824; Drug: Placebo to KVD824 |
| Part A - KVD824 - 40 mg | Experimental | 6 participants were administered 40mg of KVD824 in capsule form (1 x 40 mg capsule) on one occasion on Day 1. 2 participants received matching placebo. Receives: Drug: KVD824; Drug: Placebo to KVD824 |
| Part A - KVD824 - 80 mg | Experimental | 6 participants were administered 80mg of KVD824 in capsule form (2 x 40 mg capsules) on one occasion on Day 1. 2 participants received matching placebo. Receives: Drug: KVD824; Drug: Placebo to KVD824 |
| Part A - KVD824 - 160mg | Experimental | 6 participants were administered 160mg of KVD824 in capsule form (1 x 160 mg capsule) on one occasion on Day 1. 2 participants received matching placebo. Receives: Drug: KVD824; Drug: Placebo to KVD824 |
| Part A - KVD824 - 320 mg | Experimental | 6 participants were administered 320mg of KVD824 in capsule form (1 x 320 mg capsule) on one occasion on Day 1. 2 participants received matching placebo. Receives: Drug: KVD824; Drug: Placebo to KVD824 |
| Part A - KVD824 - 640 mg | Experimental | 6 participants were administered 640 mg of KVD824 in capsule form (2 x 320 mg capsule) on one occasion on Day 1. 2 participants received matching placebo. Receives: Drug: KVD824; Drug: Placebo to KVD824 |
| Part A - KVD824 - 1280 mg | Experimental | 6 participants were administered 1280 mg of KVD824 in capsule form (4 x 320 mg capsule) on one occasion on Day 1. 2 participants received matching placebo. Receives: Drug: KVD824; Drug: Placebo to KVD824 |
| Part B - KVD824 - 80 mg Multi-Dose | Experimental | 6 participants were administered 80 mg of KVD824 in capsule form (2 x 40 mg capsules) in multiple doses over a period of 5 days (twice a day on Days 1-4 and once in morning of Day 5; the first dose on each day was administered fasted). 2 participants received matching placebo. Receives: Drug: KVD824; Drug: Placebo to KVD824 |
| Part B - KVD824 - 160 mg Multi-Dose | Experimental | 6 participants were administered 160mg of KVD824 in capsule form (1 x 160 mg capsule) in multiple doses over a period of 5 days (twice a day on Days 1-4 and once in morning of Day 5; the first dose on each day was administered fasted). 2 participants received matching placebo. Receives: Drug: KVD824; Drug: Placebo to KVD824 |
| Part B - KVD824 - 320 mg Multi-Dose | Experimental | 6 participants were administered 320mg of KVD824 in capsule form (1 x 320 mg capsule) in multiple doses over a period of 5 days (twice a day on Days 1-4 and once in morning of Day 5; the first dose on each day was administered fasted). 2 participants received matching placebo. Receives: Drug: KVD824; Drug: Placebo to KVD824 |
| Part B - KVD824 - 640 mg Multi-Dose | Experimental | 6 participants were administered 640mg of KVD824 in capsule form (2 x 320 mg capsules) in multiple doses over a period of 5 days (twice a day on Days 1-4 and once in morning of Day 5; the first dose on each day was administered fasted). 2 participants received matching placebo. Receives: Drug: KVD824; Drug: Placebo to KVD824 |
| Part C - KVD824 - 320 mg Fasted | Experimental | 12 participants were administered 320 mg of KVD824 in capsule form (1 x 320 mg capsule) on one occasion on Day 1 in a fasted state. Receives: Drug: KVD824 |
| Part C - KVD824 - 320 mg High fat breakfast | Experimental | 12 participants were administered 320 mg of KVD824 in capsule form (1 x 320 mg capsule) on one occasion on Day 1 following consumption of a high fat breakfast. Receives: Drug: KVD824 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - Treatment Emergent Adverse Events
Number of Subjects with Treatment Emergent Adverse Events
Measured: Part A Days 0-10; Part B Days 0-12
Safety - Vital signs
Number of participants with clinically significant changes in vital signs
Measured: Part A: Days (-1)-10;Part B: Days (-1)-12
Safety - Laboratory Parameters
Number of participants with clinically significant changes in laboratory assessments
Measured: Part A: Days (-1)-10;Part B: Days (-1)-12
Safety - ECG change in QTcF
Number of subjects who had any increase in QTcF parameters.
Measured: Part A: Days (-1)-10; Part B: Days (-1)-12
Secondary outcomes (16)
Pharmacokinetic - Maximum Concentration (Cmax)
Evaluation of Cmax in all cohorts of Part A, B and C.
Measured: Part A: Predose and up to 18 samples over a 48 hour period post dose; Part B: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5; Part C: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Time to maximum concentration (Tmax)
Evaluation of Tmax for Part A, Part B and Part C
Measured: Part A: Predose and up to 18 samples over a 48 hour period post dose; Part B: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5; Part C: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Terminal Elimination Rate Constant (Kel)
Evaluation of Kel in Part A, Part B and Part C
Measured: Part A: Predose and up to 18 samples over a 48 hour period post dose; Part B: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5; Part C: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Terminal elimination half-life (t1/2)
Evaluation of t1/2 in Part A, Part B and Part C
Measured: Part A: Predose and up to 18 samples over a 48 hour period post dose; Part B: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5; Part C: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Area under the concentration-time curve from time 0 to 24 hour post dose (AUC0-24)
Evaluation of AUC (0-24) in Part A, Part B and Part C
Measured: Part A: Predose and up to 18 samples over a 48 hour period post dose; Part B: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5; Part C: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-t)
Evaluation of AUC (0-t) in Part A and Part C
Measured: Part A: Predose and up to 18 samples over a 48 hour period post dose; Part B: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5; Part C: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Evaluation of AUC (0-inf) in Part A, Part B and Part C
Measured: Part A: Predose and up to 18 samples over a 48 hour period post dose; Part B: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5; Part C: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Residual Area under the curve (AUC%extrap)
Evaluation of AUC%extrap in Part A, Part B and Part C
Measured: Part A: Predose and up to 18 samples over a 48 hour period post dose; Part B: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5; Part C: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Apparent total body clearance (CL/F)
Evaluation of CL/F in Part A, Part B and Part C
Measured: Part A: Predose and up to 18 samples over a 48 hour period post dose; Part B: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5; Part C: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Apparent Volume of Distribution (Vz/F)
Evaluation of Vz/F in Part A, Part B and Part C
Measured: Part A: Predose and up to 18 samples over a 48 hour period post dose; Part B: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5; Part C: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Area under the curve from time of first dose to 12 h post-dose (AUC0-12)
Evaluation of AUC0-12 in Part B
Measured: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5
Pharmacokinetic - Area under the curve from time of second dose to 12 h post-dose (AUC12-24)
Evaluation of AUC12-24 in Part B
Measured: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5
Pharmacokinetic - Apparent total body clearance at steady state (CLss/F)
Evaluation of Clss/F in Part B
Measured: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5
Pharmacokinetic - Maximum Concentration (Cmax) - Bioavailability Ratio Fed/Fasted
Evaluation of Cmax Bioavailability Ratio Fed/Fasted in Part C
Measured: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Area under the curve from the time of dosing to the time of the last measurable concentration (AUC 0-t) - Bioavailability Fed/Fasted Ratio
Evaluation of AUC0-t Bioavailability Ratio Fed/Fasted in Part C
Measured: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Area under the concentration-time curve from time 0 to infinity(AUC0-inf) - Bioavailability Fed/Fasted Ratio
Evaluation of AUC0-inf Bioavailability Ratio Fed/Fasted in Part C
Measured: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start12 Feb 2019
- Primary completion21 Jun 2019
- Study completion21 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hereditary AngioedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, KalVista Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05178355
- Sponsor's protocol ID
- KVD824-101
- Status last verified
- Feb 2022
- First submitted
- 16 Dec 2021
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Doses Study of the Safety, Tolerability, and Pharmacokinetics of KVD824 Followed by Crossover Food Effect Sub-study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05178355
- Acronym / sponsor ID
- KVD824-101
- Conditions
- Hereditary Angioedema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 21 Jun 2019 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a 3 part phase 1, randomized, double-blind, placebo-controlled, study of the safety, tolerability, and pharmacokinetics of KVD824 following administration of single and multiple ascending oral doses; followed by a crossover food effect sub-study in healthy male volunteers.
Detailed description
Part A was a single-centre randomized, double blinded, placebo control to investigate the safety and tolerability of single ascending doses of KVD824 administered to healthy male volunteers.
Part B was a single centre, randomized, double blinded, placebo control to investigate the safety and tolerability of multiple ascending doses of KVD824 administered to healthy male volunteers.
Part C was a single-centre, open labelled to investigate the food effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Part A - KVD824 - 10 mg | Experimental | Drug: KVD824, Drug: Placebo to KVD8246 participants were administered10 mg of KVD824 in capsule form (1 x 10 mg capsule) on one occasion on Day 1. 2 participants received matching placebo. |
| Part A - KVD824 - 20 mg | Experimental | Drug: KVD824, Drug: Placebo to KVD8246 participants were administered 20mg of KVD824 in capsule form ( 2 x 10 mg capsules) on one occasion on Day 1. 2 participants received matching placebo. |
| Part A - KVD824 - 40 mg | Experimental | Drug: KVD824, Drug: Placebo to KVD8246 participants were administered 40mg of KVD824 in capsule form (1 x 40 mg capsule) on one occasion on Day 1. 2 participants received matching placebo. |
| Part A - KVD824 - 80 mg | Experimental | Drug: KVD824, Drug: Placebo to KVD8246 participants were administered 80mg of KVD824 in capsule form (2 x 40 mg capsules) on one occasion on Day 1. 2 participants received matching placebo. |
| Part A - KVD824 - 160mg | Experimental | Drug: KVD824, Drug: Placebo to KVD8246 participants were administered 160mg of KVD824 in capsule form (1 x 160 mg capsule) on one occasion on Day 1. 2 participants received matching placebo. |
| Part A - KVD824 - 320 mg | Experimental | Drug: KVD824, Drug: Placebo to KVD8246 participants were administered 320mg of KVD824 in capsule form (1 x 320 mg capsule) on one occasion on Day 1. 2 participants received matching placebo. |
| Part A - KVD824 - 640 mg | Experimental | Drug: KVD824, Drug: Placebo to KVD8246 participants were administered 640 mg of KVD824 in capsule form (2 x 320 mg capsule) on one occasion on Day 1. 2 participants received matching placebo. |
| Part A - KVD824 - 1280 mg | Experimental | Drug: KVD824, Drug: Placebo to KVD8246 participants were administered 1280 mg of KVD824 in capsule form (4 x 320 mg capsule) on one occasion on Day 1. 2 participants received matching placebo. |
| Part B - KVD824 - 80 mg Multi-Dose | Experimental | Drug: KVD824, Drug: Placebo to KVD8246 participants were administered 80 mg of KVD824 in capsule form (2 x 40 mg capsules) in multiple doses over a period of 5 days (twice a day on Days 1-4 and once in morning of Day 5; the first dose on each day was administered fasted). 2 participants received matching placebo. |
| Part B - KVD824 - 160 mg Multi-Dose | Experimental | Drug: KVD824, Drug: Placebo to KVD8246 participants were administered 160mg of KVD824 in capsule form (1 x 160 mg capsule) in multiple doses over a period of 5 days (twice a day on Days 1-4 and once in morning of Day 5; the first dose on each day was administered fasted). 2 participants received matching placebo. |
| Part B - KVD824 - 320 mg Multi-Dose | Experimental | Drug: KVD824, Drug: Placebo to KVD8246 participants were administered 320mg of KVD824 in capsule form (1 x 320 mg capsule) in multiple doses over a period of 5 days (twice a day on Days 1-4 and once in morning of Day 5; the first dose on each day was administered fasted). 2 participants received matching placebo. |
| Part B - KVD824 - 640 mg Multi-Dose | Experimental | Drug: KVD824, Drug: Placebo to KVD8246 participants were administered 640mg of KVD824 in capsule form (2 x 320 mg capsules) in multiple doses over a period of 5 days (twice a day on Days 1-4 and once in morning of Day 5; the first dose on each day was administered fasted). 2 participants received matching placebo. |
| Part C - KVD824 - 320 mg Fasted | Experimental | Drug: KVD82412 participants were administered 320 mg of KVD824 in capsule form (1 x 320 mg capsule) on one occasion on Day 1 in a fasted state. |
| Part C - KVD824 - 320 mg High fat breakfast | Experimental | Drug: KVD82412 participants were administered 320 mg of KVD824 in capsule form (1 x 320 mg capsule) on one occasion on Day 1 following consumption of a high fat breakfast. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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 / deputy.
- Male subject willing to wear a condom and whose partner of child bearing potential uses a highly effective method of contraception (e.g. partner use of intrauterine device (IUD)) or an effective method of contraception, i.e., established method of contraception + condom, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the subject) from first dose until 3 months after last dose of IMP. Men whose partners are already pregnant must continue to use a condom during the trial and for three months thereafter.
- Subject with a body mass index (BMI) of 18-32 kg/m2.
- Subject with no clinically significant history of previous allergy / sensitivity to KVD824 or any of the excipients contained within the Investigational Medicinal Product.
Key exclusion criteria (9 listed)
- A clinically significant history of gastrointestinal disorder likely to influence Investigational Medicinal Product absorption.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 28 days or 5 half-lives (which ever is longer) prior to the first dose of Investigational Medicinal Product, unless in the opinion of the Chief Investigator the medication will not interfere with the study procedures or compromise subject safety.
- Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
- Subjects with a history of clotting abnormalities.
- A clinically significant history of drug or alcohol abuse in the last 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KVD824Active | Drug | Part A - KVD824 - 10 mg, Part A - KVD824 - 1280 mg, Part A - KVD824 - 160mg, Part A - KVD824 - 20 mg, Part A - KVD824 - 320 mg, Part A - KVD824 - 40 mg, Part A - KVD824 - 640 mg, Part A - KVD824 - 80 mg, Part B - KVD824 - 160 mg Multi-Dose, Part B - KVD824 - 320 mg Multi-Dose, Part B - KVD824 - 640 mg Multi-Dose, Part B - KVD824 - 80 mg Multi-Dose, Part C - KVD824 - 320 mg Fasted, Part C - KVD824 - 320 mg High fat breakfast |
| Placebo to KVD824Placebo | Drug | Part A - KVD824 - 10 mg, Part A - KVD824 - 1280 mg, Part A - KVD824 - 160mg, Part A - KVD824 - 20 mg, Part A - KVD824 - 320 mg, Part A - KVD824 - 40 mg, Part A - KVD824 - 640 mg, Part A - KVD824 - 80 mg, Part B - KVD824 - 160 mg Multi-Dose, Part B - KVD824 - 320 mg Multi-Dose, Part B - KVD824 - 640 mg Multi-Dose, Part B - KVD824 - 80 mg Multi-Dose |
Primary outcome
Safety - Treatment Emergent Adverse Events
Time frame: Part A Days 0-10; Part B Days 0-12
Number of Subjects with Treatment Emergent Adverse Events
Safety - Vital signs
Time frame: Part A: Days (-1)-10;Part B: Days (-1)-12
Number of participants with clinically significant changes in vital signs
Safety - Laboratory Parameters
Time frame: Part A: Days (-1)-10;Part B: Days (-1)-12
Number of participants with clinically significant changes in laboratory assessments
Safety - ECG change in QTcF
Time frame: Part A: Days (-1)-10; Part B: Days (-1)-12
Number of subjects who had any increase in QTcF parameters.
16 secondary outcomes
Pharmacokinetic - Maximum Concentration (Cmax)
Time frame: Part A: Predose and up to 18 samples over a 48 hour period post dose; Part B: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5; Part C: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Time to maximum concentration (Tmax)
Time frame: Part A: Predose and up to 18 samples over a 48 hour period post dose; Part B: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5; Part C: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Terminal Elimination Rate Constant (Kel)
Time frame: Part A: Predose and up to 18 samples over a 48 hour period post dose; Part B: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5; Part C: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Terminal elimination half-life (t1/2)
Time frame: Part A: Predose and up to 18 samples over a 48 hour period post dose; Part B: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5; Part C: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Area under the concentration-time curve from time 0 to 24 hour post dose (AUC0-24)
Time frame: Part A: Predose and up to 18 samples over a 48 hour period post dose; Part B: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5; Part C: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Area under the concentration-time curve from time 0 to last measurable time-point (AUC0-t)
Time frame: Part A: Predose and up to 18 samples over a 48 hour period post dose; Part B: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5; Part C: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Area under the concentration-time curve from time 0 to infinity (AUC0-inf)
Time frame: Part A: Predose and up to 18 samples over a 48 hour period post dose; Part B: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5; Part C: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Residual Area under the curve (AUC%extrap)
Time frame: Part A: Predose and up to 18 samples over a 48 hour period post dose; Part B: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5; Part C: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Apparent total body clearance (CL/F)
Time frame: Part A: Predose and up to 18 samples over a 48 hour period post dose; Part B: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5; Part C: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Apparent Volume of Distribution (Vz/F)
Time frame: Part A: Predose and up to 18 samples over a 48 hour period post dose; Part B: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5; Part C: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Area under the curve from time of first dose to 12 h post-dose (AUC0-12)
Time frame: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5
Pharmacokinetic - Area under the curve from time of second dose to 12 h post-dose (AUC12-24)
Time frame: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5
Pharmacokinetic - Apparent total body clearance at steady state (CLss/F)
Time frame: Pre-dose and up to 11 samples over a 24 hour period post morning dose, day 1 and 5
Pharmacokinetic - Maximum Concentration (Cmax) - Bioavailability Ratio Fed/Fasted
Time frame: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Area under the curve from the time of dosing to the time of the last measurable concentration (AUC 0-t) - Bioavailability Fed/Fasted Ratio
Time frame: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Pharmacokinetic - Area under the concentration-time curve from time 0 to infinity(AUC0-inf) - Bioavailability Fed/Fasted Ratio
Time frame: Predose and up to 16 samples over a 24 hour period post dose per treatment period.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
KalVista Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KVD824 in people with Hereditary Angioedema, run by KalVista Pharmaceuticals, Ltd. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - Treatment Emergent Adverse Events (time frame: Part A Days 0-10; Part B Days 0-12). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.