Hereditary AngioedemaPhase 1NCT05118958
Phase 1 Crossover Study in Healthy Subjects to Evaluate the PK Profile of KVD824 Following Single and Multiple Doses of Modified Release (MR) Formulations
A Phase 1 study testing KVD824 Prototype 1 modified-release tablet, KVD824 Prototype 2 modified-release tablet and KVD824 Immediate-Release Capsule 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 crossover study in healthy subjects to evaluate the pharmacokinetic profile of KVD824 following single and multiple doses of novel KVD824 modified-release formulations compared with a reference KVD824 immediate release formulation. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hereditary Angioedema
- What is being tested?
- KVD824 Prototype 1 modified-release tablet, KVD824 Prototype 2 modified-release tablet and KVD824 Immediate-Release Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 May 2020to 1 Dec 2020
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or non-pregnant, non-lactating healthy females.
- Aged 18 to 55 years, inclusive at the time of signing informed consent.
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening.
- Must be willing and able to communicate and participate in the whole study.
- Must provide written informed consent.
- Must agree to adhere to the contraception requirements.
Who cannot join
- Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1.
- Subjects who are study site employees, sponsor employees, or immediate family members of site or sponsor employees.
- Subjects who have previously been administered IMP in this study. Subjects who have taken part in one part of this study are not permitted to take part in any other study part.
- History of any drug or alcohol abuse in the past 2 years.
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type).
- A confirmed positive alcohol breath test at screening or admission.
Show all 22Show fewer
- Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission.
- Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months.
- Females of childbearing potential who are pregnant or lactating (all female subjects must have a negative serum pregnancy test at screening and urine pregnancy test on admission).
- Subjects with pregnant or lactating partners.
- Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator or delegate at screening.
- Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis as judged by the investigator. Subjects with Gilbert's Syndrome are allowed.
- Confirmed positive drugs of abuse test result.
- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results.
- Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of <70 mL/min using the Cockcroft-Gault equation.
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator.
- Subjects with a history of cholecystectomy or gall stones.
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
- Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active.
- Donation or loss of greater than 400 mL of blood within the previous 3 months.
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day, HRT or hormonal contraception) in the 14 days before IMP administration.
- Failure to satisfy the investigator of fitness to participate for any other reason.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multiple Part, Phase 1 Crossover Study in Healthy Subjects to Evaluate the Pharmacokinetic (PK) Profile of KVD824 Following Single and Multiple Doses of Novel KVD824 Modified Release (MR) Formulations Compared to a Reference KVD824 Immediate Release (IR) Formulation
This is a 3 part, phase 1 crossover study in healthy subjects to evaluate the pharmacokinetic profile of KVD824 following single and multiple doses of novel KVD824 modified-release formulations compared with a reference KVD824 immediate release formulation.
Read the detailed description
Part 1 of the study was a single-centre, open-label, non-randomised, 6-period crossover study designed to investigate the PK and safety of KVD824 MR prototype formulations (with or without an additional KVD824 IR capsule) compared to a reference KVD824 IR capsule formulation in healthy male and female subjects. Part 2 was an optional part designed to investigate the PK and safety of a selected KVD824 MR prototype tablet formulation (with or without an additional KVD824 IR capsule) in healthy male and female subjects in both the fed and fasted state. Note: this Part was not conducted as sufficient information on food effect was collected in the other Parts of the study.
Part 3 was a single-centre, randomised, double-blind, placebo-controlled, multiple dose group study to investigate the PK and safety of a selected KVD824 MR prototype tablet formulation (with or without an additional KVD824 IR capsule) in healthy male and female subjects. Part 3 started following completion of Part 1.
- Conditions
- Hereditary Angioedema
- Being tested
- KVD824 Prototype 1 modified-release tablet, KVD824 Prototype 2 modified-release tablet, KVD824 Immediate-Release Capsule, Placebo to KVD824 Prototype 1, KVD824 Prototype 3 modified-release tablet
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KVD824 Prototype 1 modified-release tabletDrug
300 mg modified-release tablet
KVD824 Prototype 2 modified-release tabletDrug
300 mg modified-release tablet
KVD824 Immediate-Release CapsuleDrug
300 mg immediate-release capsule
Placebo to KVD824 Prototype 1Drug
Placebo to 300 mg KVD824 Prototype 1 modified-release tablet
KVD824 Prototype 3 modified-release tabletDrug
300 mg modified-release tablet
| Study group | Role | What they receive |
|---|---|---|
| Part 1 - Period 1 - Prototype 1 600 mg (single dose fasted) | Experimental | 600 mg (2 x 300 mg) KVD824 prototype 1 modified-release tablet dosed orally in fasted state as a single dose Receives: Drug: KVD824 Prototype 1 modified-release tablet |
| Part 1 - Period 3 - Prototype 2 600 mg (single dose fasted) | Experimental | 600 mg (2 x 300 mg) KVD824 prototype 2 modified-release tablet dosed orally in fasted state as a single dose Receives: Drug: KVD824 Prototype 2 modified-release tablet |
| Part 1 - Period 4 - Prototype 1 900 mg (single dose fasted) | Experimental | 900 mg (3 x 300 mg) KVD824 prototype 1 modified-release tablet dosed orally in fasted state as a single dose Receives: Drug: KVD824 Prototype 1 modified-release tablet |
| Part 1 - Period 5 - Prototype 1 600 mg and Prototype 3 300 mg (single dose fasted) | Experimental | 600 mg (2 x 300 mg) KVD824 prototype 1 modified-release tablet plus 300 mg (1 x 300 mg) Prototype 3 dosed orally in fasted state as a single dose Receives: Drug: KVD824 Prototype 1 modified-release tablet; Drug: KVD824 Prototype 3 modified-release tablet |
| Part 1 - Period 6 - Prototype 1 900 mg (single dose fed) | Experimental | 900 mg (3 x 300 mg) KVD824 prototype 1 modified-release tablet dosed orally in fed state as a single dose Receives: Drug: KVD824 Prototype 1 modified-release tablet |
| Part 3 - KVD824 Prototype 1 600 mg (multiple dose fed) | Experimental | 600 mg (2 x 300 mg) KVD824 prototype 1 modified-release tablet dosed orally twice daily in fed state for 13 days with a single dose on day 14. Receives: Drug: KVD824 Prototype 1 modified-release tablet |
| Part 3 - Placebo to KVD824 Prototype 1 600 mg (multiple dose fed) | Placebo comparator | Placebo to 600 mg KVD824 prototype 1 modified-release tablet dosed orally twice daily in fed state for 13 days with a single dose on day 14. Receives: Drug: Placebo to KVD824 Prototype 1 |
| Part 3 - KVD824 Prototype 1 900 mg (multiple dose fed) | Experimental | 900 mg (3 x 300 mg) KVD824 prototype 1 modified-release tablet dosed orally twice daily in fed state for 13 days with a single dose on day 14. Receives: Drug: KVD824 Prototype 1 modified-release tablet |
| Part 3 - Placebo to KVD824 Prototype 1 900 mg (multiple dose fed) | Placebo comparator | Placebo to 900 mg KVD824 prototype 1 modified-release tablet dosed orally twice daily in fed state for 13 days with a single dose on day 14. Receives: Drug: Placebo to KVD824 Prototype 1 |
| Part 3 - KVD824 Prototype 1 900 mg (multiple dose fasted) | Experimental | 900 mg (3 x 300 mg) KVD824 prototype 1 modified-release tablet dosed orally twice daily in fasted state for 13 days with a single dose on day 14. Receives: Drug: KVD824 Prototype 1 modified-release tablet |
| Part 3 - Placebo to KVD824 Prototype 1 900 mg (multiple dose fasted) | Placebo comparator | Placebo to 900 mg KVD824 prototype 1 modified-release tablet dosed orally twice daily in fasted state for 13 days with a single dose on day 14. Receives: Drug: Placebo to KVD824 Prototype 1 |
| Part 1 - Period 2 - KVD824 IR Capsule 600 mg (single dose fasted) | Active comparator | 600 mg (2 x 300 mg) KVD824 immediate release Capsule dosed orally in fasted state as a single dose Receives: Drug: KVD824 Immediate-Release Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics - Tlag
Time prior to the first measurable concentration after single and multiple doses of KVD824
Measured: Days 1, 10 and 14
Pharmacokinetics - Tmax
Time of maximum observed concentration after single and multiple doses of KVD824 with and without food
Measured: Days 1, 10 and 14
Pharmacokinetics - Cmax
Maximum observed concentration after single and multiple doses of KVD824 with and without food
Measured: Days 1, 10 and 14
Pharmacokinetics - Cmax/Dose
Maximum observed concentration divided by dose
Measured: Days 1, 10 and 14
Pharmacokinetics - C12
Plasma concentration observed at time 12 h after single and multiple doses
Measured: Days 1, 10 and 14
Pharmacokinetics - C24
Plasma concentration observed at time 24 h after single and multiple doses
Measured: Days 1, 10 and 14
Pharmacokinetics - Ctrough
Concentration prior to the morning dose on Days 2-14 and prior to the evening dose on Days 2-13
Measured: Days 2-14
Pharmacokinetics - Cmin
Minimum observed concentration during the dosing interval (between dose time and dose time plus tau) after single and multiple doses of KVD824 with and without food
Measured: Days 2-14
Pharmacokinetics - Cavg
Average concentration (AUC(0-tau)/tau)
Measured: Days 2-14
Pharmacokinetics - AUC(0-12)
Area under the curve from time 0 to 12 hours post-dose after single and multiple doses
Measured: Days 1, 10 and 14
Pharmacokinetics - AUC(0-12)/Dose
Area under the curve from time 0 to 12 hours post-dose divided by dose
Measured: Days 1, 10 and 14
Pharmacokinetics - AUC(0-24)
Area under the curve from time 0 to 24 hours post-dose after single and multiple doses
Measured: Days 1, 10 and 14
Pharmacokinetics - AUC(0-24)/Dose
Area under the curve from time 0 to 24 hours post-dose divided by dose
Measured: Days 1, 10 and 14
Pharmacokinetics - AUC(0-last)
Area under the curve from time 0 to the time of last measurable concentration after single and multiple doses
Measured: Days 1, 10 and 14
Pharmacokinetics - AUC(0-last)/Dose
Area under the curve from time 0 to the time of last measurable concentration divided by dose
Measured: Days 1, 10 and 14
Pharmacokinetics - AUC(0-tau)
Area under the curve for the defined interval between doses (tau)
Measured: Days 1, 10 and 14
Pharmacokinetics - AUC(0-inf)
Area under the curve from time 0 extrapolated to infinity
Measured: Days 1, 10 and 14
Pharmacokinetics - AUC(0-inf)/D
Area under the curve from time 0 extrapolated to infinity divided by dose
Measured: Days 1, 10 and 14
Pharmacokinetics - AUCextrap
Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity
Measured: Days 1, 10 and 14
Pharmacokinetics - T1/2
Terminal elimination half-life after single and multiple doses of KVD824 with and without food
Measured: Days 1, 10 and 14
Pharmacokinetics - Lambda-z
First order rate constant associated with the terminal (log-linear) portion of the curve after single and multiple doses
Measured: Days 1, 10 and 14
Pharmacokinetics - CL/F
Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown
Measured: Days 1, 10 and 14
Pharmacokinetics - CL/Ftau
Total body clearance calculated using AUC(0-tau) after repeated extravascular administration, where F (fraction of dose bioavailable) is unknown
Measured: Days 1, 10 and 14
Pharmacokinetics - Vz/F
Apparent volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown
Measured: Days 1, 10 and 14
Pharmacokinetics - Vz/Flau
Apparent volume of distribution based on the terminal phase calculated using AUC(0-tau) after extravascular administration where F (fraction of dose bioavailable) is unknown
Measured: Days 1, 10 and 14
Pharmacokinetics - Frel Cmax
Relative bioavailability based on Cmax
Measured: Days 1, 10 and 14
Pharmacokinetics - Frel AUC(0-12)
Relative bioavailability based on AUC(0-12)
Measured: Days 1, 10 and 14
Pharmacokinetics - Frel AUC(0-inf)
Relative bioavailability based on AUC(0-inf)
Measured: Days 1, 10 and 14
Pharmacokinetics - AR Cmax
Accumulation ratio based on Cmax repeated dose/Cmax single dose
Measured: Days 1, 10 and 14
Pharmacokinetics - Fluctuation
Peak to trough fluctuation (Cmax-Cmin)/Cavg × 100
Measured: Days 1, 10 and 14
Secondary outcomes (5)
Safety - Adverse Events
Number of Subjects with Adverse Events
Measured: Change from pre-dose to last visit (up to 14 days)
Safety - Serious Adverse Events
Number of Subjects with Serious Adverse Events
Measured: Change from pre-dose to last visit (up to 14 days)
Safety - Laboratory Assessments
Number of participants with clinically significant changes in laboratory assessments
Measured: Throughout the trial to last visit (up to 14 days)
Safety - Vital Signs
Number of participants with clinically significant changes in vital signs
Measured: Throughout the trial to last visit (up to 14 days)
Safety - ECG
Number of participants with clinically significant changes in electrocardiogram (ECG) measurements
Measured: Throughout the trial to last visit (up to 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start19 May 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118958
- Sponsor's protocol ID
- KVD824-102
- Status last verified
- Nov 2021
- First submitted
- 26 Oct 2021
- Last updated
- 12 Nov 2021
- 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 12 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Part, Phase 1 Crossover Study in Healthy Subjects to Evaluate the Pharmacokinetic (PK) Profile of KVD824 Following Single and Multiple Doses of Novel KVD824 Modified Release (MR) Formulations Compared to a Reference KVD824 Immediate Release (IR) Formulation
- ClinicalTrials.gov ID
- NCT05118958
- Acronym / sponsor ID
- KVD824-102
- Conditions
- Hereditary Angioedema
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- KalVista Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 May 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 12 Nov 2021 (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 crossover study in healthy subjects to evaluate the pharmacokinetic profile of KVD824 following single and multiple doses of novel KVD824 modified-release formulations compared with a reference KVD824 immediate release formulation.
Detailed description
Part 1 of the study was a single-centre, open-label, non-randomised, 6-period crossover study designed to investigate the PK and safety of KVD824 MR prototype formulations (with or without an additional KVD824 IR capsule) compared to a reference KVD824 IR capsule formulation in healthy male and female subjects. Part 2 was an optional part designed to investigate the PK and safety of a selected KVD824 MR prototype tablet formulation (with or without an additional KVD824 IR capsule) in healthy male and female subjects in both the fed and fasted state. Note: this Part was not conducted as sufficient information on food effect was collected in the other Parts of the study.
Part 3 was a single-centre, randomised, double-blind, placebo-controlled, multiple dose group study to investigate the PK and safety of a selected KVD824 MR prototype tablet formulation (with or without an additional KVD824 IR capsule) in healthy male and female subjects. Part 3 started following completion of Part 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Part 1 - Period 1 - Prototype 1 600 mg (single dose fasted) | Experimental | Drug: KVD824 Prototype 1 modified-release tablet600 mg (2 x 300 mg) KVD824 prototype 1 modified-release tablet dosed orally in fasted state as a single dose |
| Part 1 - Period 3 - Prototype 2 600 mg (single dose fasted) | Experimental | Drug: KVD824 Prototype 2 modified-release tablet600 mg (2 x 300 mg) KVD824 prototype 2 modified-release tablet dosed orally in fasted state as a single dose |
| Part 1 - Period 4 - Prototype 1 900 mg (single dose fasted) | Experimental | Drug: KVD824 Prototype 1 modified-release tablet900 mg (3 x 300 mg) KVD824 prototype 1 modified-release tablet dosed orally in fasted state as a single dose |
| Part 1 - Period 5 - Prototype 1 600 mg and Prototype 3 300 mg (single dose fasted) | Experimental | Drug: KVD824 Prototype 1 modified-release tablet, Drug: KVD824 Prototype 3 modified-release tablet600 mg (2 x 300 mg) KVD824 prototype 1 modified-release tablet plus 300 mg (1 x 300 mg) Prototype 3 dosed orally in fasted state as a single dose |
| Part 1 - Period 6 - Prototype 1 900 mg (single dose fed) | Experimental | Drug: KVD824 Prototype 1 modified-release tablet900 mg (3 x 300 mg) KVD824 prototype 1 modified-release tablet dosed orally in fed state as a single dose |
| Part 3 - KVD824 Prototype 1 600 mg (multiple dose fed) | Experimental | Drug: KVD824 Prototype 1 modified-release tablet600 mg (2 x 300 mg) KVD824 prototype 1 modified-release tablet dosed orally twice daily in fed state for 13 days with a single dose on day 14. |
| Part 3 - Placebo to KVD824 Prototype 1 600 mg (multiple dose fed) | Placebo comparator | Drug: Placebo to KVD824 Prototype 1Placebo to 600 mg KVD824 prototype 1 modified-release tablet dosed orally twice daily in fed state for 13 days with a single dose on day 14. |
| Part 3 - KVD824 Prototype 1 900 mg (multiple dose fed) | Experimental | Drug: KVD824 Prototype 1 modified-release tablet900 mg (3 x 300 mg) KVD824 prototype 1 modified-release tablet dosed orally twice daily in fed state for 13 days with a single dose on day 14. |
| Part 3 - Placebo to KVD824 Prototype 1 900 mg (multiple dose fed) | Placebo comparator | Drug: Placebo to KVD824 Prototype 1Placebo to 900 mg KVD824 prototype 1 modified-release tablet dosed orally twice daily in fed state for 13 days with a single dose on day 14. |
| Part 3 - KVD824 Prototype 1 900 mg (multiple dose fasted) | Experimental | Drug: KVD824 Prototype 1 modified-release tablet900 mg (3 x 300 mg) KVD824 prototype 1 modified-release tablet dosed orally twice daily in fasted state for 13 days with a single dose on day 14. |
| Part 3 - Placebo to KVD824 Prototype 1 900 mg (multiple dose fasted) | Placebo comparator | Drug: Placebo to KVD824 Prototype 1Placebo to 900 mg KVD824 prototype 1 modified-release tablet dosed orally twice daily in fasted state for 13 days with a single dose on day 14. |
| Part 1 - Period 2 - KVD824 IR Capsule 600 mg (single dose fasted) | Active comparator | Drug: KVD824 Immediate-Release Capsule600 mg (2 x 300 mg) KVD824 immediate release Capsule dosed orally in fasted state as a single dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy males or non-pregnant, non-lactating healthy females.
- Aged 18 to 55 years, inclusive at the time of signing informed consent.
- Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening.
- Must be willing and able to communicate and participate in the whole study.
- Must provide written informed consent.
Key exclusion criteria (22 listed)
- Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1.
- Subjects who are study site employees, sponsor employees, or immediate family members of site or sponsor employees.
- Subjects who have previously been administered IMP in this study. Subjects who have taken part in one part of this study are not permitted to take part in any other study part.
- History of any drug or alcohol abuse in the past 2 years.
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 Units = 125 mL glass of wine, depending on type).
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 |
|---|---|---|
| KVD824 Prototype 1 modified-release tablet300 mg modified-release tablet | Drug | Part 1 - Period 1 - Prototype 1 600 mg (single dose fasted), Part 1 - Period 4 - Prototype 1 900 mg (single dose fasted), Part 1 - Period 5 - Prototype 1 600 mg and Prototype 3 300 mg (single dose fasted), Part 1 - Period 6 - Prototype 1 900 mg (single dose fed), Part 3 - KVD824 Prototype 1 600 mg (multiple dose fed), Part 3 - KVD824 Prototype 1 900 mg (multiple dose fasted), Part 3 - KVD824 Prototype 1 900 mg (multiple dose fed) |
| KVD824 Prototype 2 modified-release tablet300 mg modified-release tablet | Drug | Part 1 - Period 3 - Prototype 2 600 mg (single dose fasted) |
| KVD824 Immediate-Release Capsule300 mg immediate-release capsule | Drug | Part 1 - Period 2 - KVD824 IR Capsule 600 mg (single dose fasted) |
| Placebo to KVD824 Prototype 1Placebo to 300 mg KVD824 Prototype 1 modified-release tablet | Drug | Part 3 - Placebo to KVD824 Prototype 1 600 mg (multiple dose fed), Part 3 - Placebo to KVD824 Prototype 1 900 mg (multiple dose fasted), Part 3 - Placebo to KVD824 Prototype 1 900 mg (multiple dose fed) |
| KVD824 Prototype 3 modified-release tablet300 mg modified-release tablet | Drug | Part 1 - Period 5 - Prototype 1 600 mg and Prototype 3 300 mg (single dose fasted) |
Primary outcome
Pharmacokinetics - Tlag
Time frame: Days 1, 10 and 14
Time prior to the first measurable concentration after single and multiple doses of KVD824
Pharmacokinetics - Tmax
Time frame: Days 1, 10 and 14
Time of maximum observed concentration after single and multiple doses of KVD824 with and without food
Pharmacokinetics - Cmax
Time frame: Days 1, 10 and 14
Maximum observed concentration after single and multiple doses of KVD824 with and without food
Pharmacokinetics - Cmax/Dose
Time frame: Days 1, 10 and 14
Maximum observed concentration divided by dose
Pharmacokinetics - C12
Time frame: Days 1, 10 and 14
Plasma concentration observed at time 12 h after single and multiple doses
Pharmacokinetics - C24
Time frame: Days 1, 10 and 14
Plasma concentration observed at time 24 h after single and multiple doses
Pharmacokinetics - Ctrough
Time frame: Days 2-14
Concentration prior to the morning dose on Days 2-14 and prior to the evening dose on Days 2-13
Pharmacokinetics - Cmin
Time frame: Days 2-14
Minimum observed concentration during the dosing interval (between dose time and dose time plus tau) after single and multiple doses of KVD824 with and without food
Pharmacokinetics - Cavg
Time frame: Days 2-14
Average concentration (AUC(0-tau)/tau)
Pharmacokinetics - AUC(0-12)
Time frame: Days 1, 10 and 14
Area under the curve from time 0 to 12 hours post-dose after single and multiple doses
Pharmacokinetics - AUC(0-12)/Dose
Time frame: Days 1, 10 and 14
Area under the curve from time 0 to 12 hours post-dose divided by dose
Pharmacokinetics - AUC(0-24)
Time frame: Days 1, 10 and 14
Area under the curve from time 0 to 24 hours post-dose after single and multiple doses
Pharmacokinetics - AUC(0-24)/Dose
Time frame: Days 1, 10 and 14
Area under the curve from time 0 to 24 hours post-dose divided by dose
Pharmacokinetics - AUC(0-last)
Time frame: Days 1, 10 and 14
Area under the curve from time 0 to the time of last measurable concentration after single and multiple doses
Pharmacokinetics - AUC(0-last)/Dose
Time frame: Days 1, 10 and 14
Area under the curve from time 0 to the time of last measurable concentration divided by dose
Pharmacokinetics - AUC(0-tau)
Time frame: Days 1, 10 and 14
Area under the curve for the defined interval between doses (tau)
Pharmacokinetics - AUC(0-inf)
Time frame: Days 1, 10 and 14
Area under the curve from time 0 extrapolated to infinity
Pharmacokinetics - AUC(0-inf)/D
Time frame: Days 1, 10 and 14
Area under the curve from time 0 extrapolated to infinity divided by dose
Pharmacokinetics - AUCextrap
Time frame: Days 1, 10 and 14
Area under the curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity
Pharmacokinetics - T1/2
Time frame: Days 1, 10 and 14
Terminal elimination half-life after single and multiple doses of KVD824 with and without food
Pharmacokinetics - Lambda-z
Time frame: Days 1, 10 and 14
First order rate constant associated with the terminal (log-linear) portion of the curve after single and multiple doses
Pharmacokinetics - CL/F
Time frame: Days 1, 10 and 14
Total body clearance calculated after a single extravascular administration where F (fraction of dose bioavailable) is unknown
Pharmacokinetics - CL/Ftau
Time frame: Days 1, 10 and 14
Total body clearance calculated using AUC(0-tau) after repeated extravascular administration, where F (fraction of dose bioavailable) is unknown
Pharmacokinetics - Vz/F
Time frame: Days 1, 10 and 14
Apparent volume of distribution based on the terminal phase calculated using AUC(0-inf) after a single extravascular administration where F (fraction of dose bioavailable) is unknown
Pharmacokinetics - Vz/Flau
Time frame: Days 1, 10 and 14
Apparent volume of distribution based on the terminal phase calculated using AUC(0-tau) after extravascular administration where F (fraction of dose bioavailable) is unknown
Pharmacokinetics - Frel Cmax
Time frame: Days 1, 10 and 14
Relative bioavailability based on Cmax
Pharmacokinetics - Frel AUC(0-12)
Time frame: Days 1, 10 and 14
Relative bioavailability based on AUC(0-12)
Pharmacokinetics - Frel AUC(0-inf)
Time frame: Days 1, 10 and 14
Relative bioavailability based on AUC(0-inf)
Pharmacokinetics - AR Cmax
Time frame: Days 1, 10 and 14
Accumulation ratio based on Cmax repeated dose/Cmax single dose
Pharmacokinetics - Fluctuation
Time frame: Days 1, 10 and 14
Peak to trough fluctuation (Cmax-Cmin)/Cavg × 100
5 secondary outcomes
Safety - Adverse Events
Time frame: Change from pre-dose to last visit (up to 14 days)
Safety - Serious Adverse Events
Time frame: Change from pre-dose to last visit (up to 14 days)
Safety - Laboratory Assessments
Time frame: Throughout the trial to last visit (up to 14 days)
Safety - Vital Signs
Time frame: Throughout the trial to last visit (up to 14 days)
Safety - ECG
Time frame: Throughout the trial to last visit (up to 14 days)
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 12 Nov 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Prototype 1 modified-release tablet, KVD824 Prototype 2 modified-release tablet and KVD824 Immediate-Release Capsule 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 6 inclusion and 22 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 12 Nov 2021. 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. Some participants in this study may receive a placebo. 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?
Pharmacokinetics - Tlag (time frame: Days 1, 10 and 14). The study lists 30 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 12 Nov 2021.