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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04845321
Other study ID # VNRX-9945-101
Secondary ID
Status Terminated
Phase Phase 1
First received
Last updated
Start date June 23, 2021
Est. completion date October 31, 2021

Study information

Verified date June 2022
Source Venatorx Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a 2-part first-in-human dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-9945.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 32
Est. completion date October 31, 2021
Est. primary completion date October 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
VNRX-9945
Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)
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)

Locations

Country Name City State
New Zealand New Zealand Clinical Research Auckland

Sponsors (2)

Lead Sponsor Collaborator
Venatorx Pharmaceuticals, Inc. Novotech (Australia) Pty Limited

Country where clinical trial is conducted

New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Part 1: Number of subjects with adverse events Up to 8 days after last administration of study drug
Primary Part 2: Number of subjects with adverse events Up to 8 days after last administration of study drug
Secondary Part 1: AUC0-tau Days 1-6 (Days 1-12 for fasted/fed cohort)
Secondary Part 1: Cmax Days 1-6 (Days 1-12 for fasted/fed cohort)
Secondary Part 1: tmax Days 1-6 (Days 1-12 for fasted/fed cohort)
Secondary Part 1: AUCinf Days 1-6 (Days 1-12 for fasted/fed cohort)
Secondary Part 1: t1/2 Days 1-6 (Days 1-12 for fasted/fed cohort)
Secondary Part 2: AUC0-tau Day 1 and Following Last Dose on Day 14
Secondary Part 2: Cmax Day 1 and Following Last Dose on Day 14
Secondary Part 2: tmax Day 1 and Following Last Dose on Day 14
Secondary Part 2: t1/2 Following Last Dose on Day 14
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