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

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ClinicalTrials.gov Identifier: NCT04349800
Recruitment Status : Completed
First Posted : April 16, 2020
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
KalVista Pharmaceuticals, Ltd.

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

Condition or disease Intervention/treatment Phase
Hereditary Angioedema Drug: KVD900 Drug: Placebo to KVD900 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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
Actual Study Start Date : January 4, 2018
Actual Primary Completion Date : September 10, 2018
Actual Study Completion Date : September 10, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single Ascending Dose - 5 mg Drug: KVD900
Active

Drug: Placebo to KVD900
Placebo

Experimental: Single Ascending Dose - 10 mg Drug: KVD900
Active

Drug: Placebo to KVD900
Placebo

Experimental: Single Ascending Dose - 20 mg Drug: KVD900
Active

Drug: Placebo to KVD900
Placebo

Experimental: Single Ascending Dose - 40 mg Drug: KVD900
Active

Drug: Placebo to KVD900
Placebo

Experimental: Single Ascending Dose - 80 mg Drug: KVD900
Active

Drug: Placebo to KVD900
Placebo

Experimental: Single Ascending Dose - 160 mg Drug: KVD900
Active

Drug: Placebo to KVD900
Placebo

Experimental: Single Ascending Dose - 300 mg Drug: KVD900
Active

Drug: Placebo to KVD900
Placebo

Experimental: Single Ascending Dose - 600 mg Drug: KVD900
Active

Drug: Placebo to KVD900
Placebo

Experimental: Formulation Screen Drug: KVD900
Active

Experimental: Food Effect Drug: KVD900
Active




Primary Outcome Measures :
  1. Number of Subjects with Adverse Events [ Time Frame: Change from pre-dose to last visit, 5-7 days post dose. ]
  2. Number of Subjects with Serious Adverse Events [ Time Frame: Change from pre-dose to last visit, 5-7 days post dose. ]
  3. Number of participants with clinically significant changes in laboratory assessments [ Time Frame: Throughout study until last visit, 5-7 days post dose. ]
  4. Number of participants with clinically significant changes in vital signs [ Time Frame: Throughout study until last visit, 5-7 days post dose. ]
  5. Number of participants with clinically significant changes in electrocardiogram (ECG) measurements [ Time Frame: Throughout study until last visit, 5-7 days post dose. ]

Secondary Outcome Measures :
  1. Pharmacokinetics - Cmax [ Time Frame: Up to 48 hours post dose ]
    Derived from time-concentration plasma levels of KVD900

  2. Pharmacokinetics - AUC0-t [ Time Frame: Up to 48 hours post dose ]
    Derived from time-concentration plasma levels of KVD900

  3. Pharmacokinetics - AUC0-24 [ Time Frame: Up to 24 hours post dose ]
    Derived from time-concentration plasma levels of KVD900

  4. Pharmacokinetics - AUC0-inf [ Time Frame: Up to 48 hours post dose ]
    Derived from time-concentration plasma levels of KVD900

  5. Pharmacokinetics - food effect (Part C only) [ Time Frame: 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

  6. Pharmacokinetics - formulation bridge - relative bioavailability (Part B only) [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04349800


Locations
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United Kingdom
KalVista Investigative Site
Wales, United Kingdom
Sponsors and Collaborators
KalVista Pharmaceuticals, Ltd.
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Responsible Party: KalVista Pharmaceuticals, Ltd.
ClinicalTrials.gov Identifier: NCT04349800    
Other Study ID Numbers: KVD900-101
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn