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VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04845321
Recruitment Status : Terminated (Part 2 terminated, unrelated to safety.)
First Posted : April 14, 2021
Last Update Posted : June 21, 2022
Sponsor:
Collaborator:
Novotech (Australia) Pty Limited
Information provided by (Responsible Party):
Venatorx Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE April 10, 2021
First Posted Date  ICMJE April 14, 2021
Last Update Posted Date June 21, 2022
Actual Study Start Date  ICMJE June 23, 2021
Actual Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2021)
  • Part 1: Number of subjects with adverse events [ Time Frame: Up to 8 days after last administration of study drug ]
  • Part 2: Number of subjects with adverse events [ Time Frame: Up to 8 days after last administration of study drug ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2021)
  • Part 1: AUC0-tau [ Time Frame: Days 1-6 (Days 1-12 for fasted/fed cohort) ]
  • Part 1: Cmax [ Time Frame: Days 1-6 (Days 1-12 for fasted/fed cohort) ]
  • Part 1: tmax [ Time Frame: Days 1-6 (Days 1-12 for fasted/fed cohort) ]
  • Part 1: AUCinf [ Time Frame: Days 1-6 (Days 1-12 for fasted/fed cohort) ]
  • Part 1: t1/2 [ Time Frame: Days 1-6 (Days 1-12 for fasted/fed cohort) ]
  • Part 2: AUC0-tau [ Time Frame: Day 1 and Following Last Dose on Day 14 ]
  • Part 2: Cmax [ Time Frame: Day 1 and Following Last Dose on Day 14 ]
  • Part 2: tmax [ Time Frame: Day 1 and Following Last Dose on Day 14 ]
  • Part 2: t1/2 [ Time Frame: Following Last Dose on Day 14 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VNRX-9945 Safety and Pharmacokinetics in Healthy Adult Volunteers
Official Title  ICMJE Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Single and Multiple Ascending Doses of VNRX-9945 in Healthy Adult Volunteers
Brief Summary This is a 2-part first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-9945.
Detailed Description In Part 1, subjects will receive a single dose of VNRX-9945 or placebo. Subjects enrolled in the food effect cohort will receive a dose in a fasted and fed state (total 2 doses) of VNRX-9945 or placebo following an appropriate washout period between the doses. In Part 2, subjects will receive doses of VNRX-9945 or placebo daily for 14 days.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE
  • Drug: VNRX-9945
    Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)
  • Drug: Placebo for VNRX-9945
    Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)
Study Arms  ICMJE
  • Experimental: VNRX-9945
    Oral dosing
    Intervention: Drug: VNRX-9945
  • Placebo Comparator: Placebo
    Oral dosing
    Intervention: Drug: Placebo for VNRX-9945
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 Terminated
Actual Enrollment  ICMJE
 (submitted: June 14, 2022)
32
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2021)
80
Actual Study Completion Date  ICMJE October 31, 2021
Actual Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Healthy adults 18-55 years
  2. Males or non-pregnant, non-lactating females
  3. Body mass index (BMI) between 18 and 32.0 kg/m2 and total body weight >50 kg (110 lbs)
  4. Normal blood pressure
  5. Normal lab tests

Exclusion Criteria:

  1. Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder
  2. History of severe allergic or anaphylactic reaction
  3. Abnormal ECG or history of clinically significant abnormal rhythm disorder
  4. Positive alcohol, drug, or tobacco use/test
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04845321
Other Study ID Numbers  ICMJE VNRX-9945-101
Has Data Monitoring Committee Not Provided
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 Not Provided
Current Responsible Party Venatorx Pharmaceuticals, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Venatorx Pharmaceuticals, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Novotech (Australia) Pty Limited
Investigators  ICMJE Not Provided
PRS Account Venatorx Pharmaceuticals, Inc.
Verification Date June 2022

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