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Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With Inzomelid

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ClinicalTrials.gov Identifier: NCT04015076
Recruitment Status : Completed
First Posted : July 10, 2019
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Inflazome UK Ltd

Tracking Information
First Submitted Date  ICMJE July 8, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date March 27, 2020
Actual Study Start Date  ICMJE July 16, 2019
Actual Primary Completion Date March 23, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2019)
  • Incidence of treatment emergent advert events [Safety and Tolerability] [ Time Frame: Day 1-8 for SAD, Day 1-16 for MAD ]
    Incidence, frequency and severity of treatment emergent advert events
  • Peak Plasma Concentration (Cmax)-single dose [ Time Frame: Day 1-3 ]
    Peak plasma concentration following single dose administration
  • Area under the plasma concentration versus time curve (AUC)- single dose [ Time Frame: Day 1-3 ]
    AUC following single dose administration
  • Peak Plasma Concentration (Cmax)-multiple dose [ Time Frame: Days 1-9 ]
    Peak plasma concentration following multiple dose administration
  • Area under the plasma concentration versus time curve (AUC)- multiple dose [ Time Frame: Days 1-9 ]
    AUC following multiple dose administration
  • Peak Plasma Concentration (Cmax)-multiple dose [ Time Frame: Days 1-16 ]
    Peak plasma concentration following multiple dose administration
  • Area under the plasma concentration versus time curve (AUC)- multiple dose [ Time Frame: Days 1-16 ]
    AUC following multiple dose administration
Original Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • Incidence of treatment emergent advert events [Safety and Tolerability] [ Time Frame: Day 1-8 for SAD, Day 1-16 for MAD ]
    Incidence, frequency and severity of treatment emergent advert events
  • Peak Plasma Concentration (Cmax)-single dose [ Time Frame: Day 1-3 ]
    Peak plasma concentration following single dose administration
  • Area under the plasma concentration versus time curve (AUC)- single dose [ Time Frame: Day 1-3 ]
    AUC following single dose administration
  • Peak Plasma Concentration (Cmax)-multiple dose [ Time Frame: Days 1-9 ]
    Peak plasma concentration following multiple dose administration
  • Area under the plasma concentration versus time curve (AUC)- multiple dose [ Time Frame: Days 1-9 ]
    AUC following multiple dose administration
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2019)
  • Pharmacodynamic activity [ Time Frame: Day 1-3 for SAD and Day 1-9 for MAD ]
    NLRP3 Inhibition in whole blood
  • Reduction in CAPS symptom scores [ Time Frame: Days 1-15 ]
    Reduction in Physician Assessed CAPS scores based on 8 point questionnaire
Original Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
Pharmacodynamic activity [ Time Frame: Day 1-3 for SAD and Day 1-9 for MAD ]
NLRP3 Inhibition in whole blood
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Tolerability, Pharmacokinetic and Pharmacodynamic Study With Inzomelid
Official Title  ICMJE A Phase 1, Randomised, Double-Blind, Placebo Controlled, Single and Multiple Ascending Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Effect of Inzomelid in Healthy Adult Participants as Well as an Open Label Cohort to Confirm the Safety, Pharmacokinetics, and Pharmacodynamics of Inzomelid in Adult Patients With Cryopyrin-Associated Periodic Syndromes
Brief Summary This is a first in human (FIH), single-centre, double blind, randomised, cross-over, SAD followed by a MAD study of Inzomelid. The study is designed to evaluate the safety, tolerability, PK, PD, and food effect of Inzomelid in healthy adult participants and to evaluate the safety, tolerability, PK, PD, and preliminary clinical efficacy of Inzomelid in adult patients with CAPS. Oversight will be provided by a safety monitoring committee (SMC) comprised of the Investigator, the Sponsor's Medical Monitor and an Independent Medical Monitor.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Inzomelid
    Active Drug
  • Drug: Placebo
    Placebo to Match
Study Arms  ICMJE
  • Experimental: Single Ascending Dose
    Inzomelid or Placebo
    Interventions:
    • Drug: Inzomelid
    • Drug: Placebo
  • Experimental: Multiple Ascending Dose
    Inzomelid or Placebo
    Interventions:
    • Drug: Inzomelid
    • Drug: Placebo
  • Experimental: Patients with CAPS
    Inzomelid Open Label
    Intervention: Drug: Inzomelid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2020)
80
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2019)
72
Actual Study Completion Date  ICMJE March 23, 2020
Actual Primary Completion Date March 23, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria- Healthy Volunteers:

  • Healthy male or female volunteers, aged 18 to 65 years (inclusive at the time of informed consent);
  • Participants must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening and/or before administration of the initial dose of study drug;
  • Participants must have a Body Mass Index (BMI) between ≥18.0 and ≤32.0 kg/m2 at Screening;

Inclusion Criteria- CAPS Patients:

* Patients with a confirmed diagnosis of CAPS (FCAS, NOMID, or MWS) aged 18 to 70 years (inclusive at the time of informed consent);

Exclusion Criteria- Healthy Volunteers:

  • Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period;
  • Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of the participant;
  • Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol;

Exclusion Criteria- CAPS Patients:

  • Live vaccinations within 3 months prior to Screening, for the duration of the study and for up to 3 months following the last dose of study drug;
  • Positive QuantiFERON test at the Screening visit or within 2 months prior to Screening.

Participants who have a positive QuantiFERON test with documentation of BCG vaccination, who are at low environmental risk for TB infection or reactivation, and have a negative chest X-ray can be included;

* Pregnant or lactating at Screening or planning to becomepregnant (self or partner) at any time during the study, including the follow-up period;

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04015076
Other Study ID Numbers  ICMJE IZD174-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Inflazome UK Ltd
Study Sponsor  ICMJE Inflazome UK Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ben Snyder, MB, BS Nucleus Network
PRS Account Inflazome UK Ltd
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP