| Trial ID: | L0365 |
| Source ID: | NCT04931147
|
| Associated Drug: |
RXC007
|
| Title: |
A 3-part Study to Evaluate Safety, Tolerability, Food Effect and Drug-drug Interactions of RXC007 in Healthy Volunteers
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Fibrosis|Inflammation|Idiopathic Pulmonary Fibrosis|Non-alcoholic Steatohepatitis|Liver Diseases|Kidney Diseases
|
| Interventions: |
Drug: RXC007|Drug: RXC007 Matching Placebo
|
| Outcome Measures: |
Treatment Emergent Adverse Events|Number of participants who report a change from normal range values for laboratory safety parameters (serum biochemistry, serum haematology or urinalysis) from first dose on Day 1 to post-study follow up visit.|Number of participants who report a change from normal range values for vital signs parameters (blood pressure, pulse rate, respiration rate, oral body temperature) from first dose on Day 1 to post-study follow up visit.|Number of participants who report a change from normal range values for any of the associated 12-Lead ECG parameters (heart rate, PR interval, QRS width, QT interval and QTcF interval) from first dose on Day 1 to post-study follow up visit.|Pharmacokinetic Parameters - Part A - Maximum observed concentration (Cmax)|Pharmacokinetic Parameters - Part A - Time to maximum observed concentration (Tmax)|Pharmacokinetic Parameters - Part A - Elimination rate constant (??z)|Pharmacokinetic Parameters - Part A - Terminal elimination half-life (t1/2)|Pharmacokinetic Parameters - Part A - Area under the concentration-time curve (AUC) from the time of dosing to the time of the last measurable concentration (AUC0-t)|Pharmacokinetic Parameters - Part A - Area under the concentration-time curve (AUC) extrapolated to infinity (AUC0-inf)|Pharmacokinetic Parameters - Part A - Residual Area (AUC%extrapolated)|Pharmacokinetic Parameters - Part A - Total apparent clearance following extravascular administration (CL/F)|Pharmacokinetic Parameters - Part A - Apparent volume of distribution following extravascular administration (Vz/F)|Pharmacokinetic Parameters - Part B - Maximum observed concentration (Cmax)|Pharmacokinetic Parameters - Part B - Time to maximum observed concentration (Tmax)|Pharmacokinetic Parameters - Part B - Elimination rate constant (??z)|Pharmacokinetic Parameters - Part B - Terminal elimination half-life (t1/2)|Pharmacokinetic Parameters - Part B - Area under the concentration-time curve (AUC) from 0 to ??, where ?? is the dosing interval (0 - 24 h) (AUC0-??)|Pharmacokinetic Parameters - Part B - Area under the concentration-time curve (AUC) from the time of dosing to the time of the last measurable concentration (AUC0-t)|Pharmacokinetic Parameters - Part B - Area under the concentration-time curve (AUC) extrapolated to infinity (AUC0-inf)|Pharmacokinetic Parameters - Part B - Residual area (AUC%extrapolated)|Pharmacokinetic Parameters - Part B - Accumulation ratio calculated from Cmax (ARCmax)|Pharmacokinetic Parameters - Part B - Accumulation ratio calculated from AUC (ARAUC)|Pharmacokinetic Parameters - Part B - Total apparent clearance following extravascular administration (CL/F)|Pharmacokinetic Parameters - Part B - Apparent volume of distribution following extravascular administration (Vz/F)
|
| Sponsor/Collaborators: |
Redx Pharma Plc|Simbec Research
|
| Gender: |
Male
|
| Age: |
18 Years to 55 Years ?? (Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
80
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Sequential Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
May 13, 2021
|
| Completion Date: |
December 31, 2021
|
| Results First Posted: |
--
|
| Last Update Posted: |
June 18, 2021
|
| Locations: |
Simbec-Orion Clinical Pharmacology, Merthyr Tydfil, Mid Glamorgan, United Kingdom
|
| URL: |
https://ClinicalTrials.gov/show/NCT04931147
|
