A 3-part Study to Evaluate Safety, Tolerability, Food Effect and Drug-drug Interactions of RXC007 in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

May 13, 2021

Primary Completion Date

March 8, 2023

Study Completion Date

March 8, 2023

Conditions
FibrosisInflammationIdiopathic Pulmonary FibrosisNon-alcoholic SteatohepatitisLiver DiseasesKidney Diseases
Interventions
DRUG

RXC007

"RXC007 will be administered in the form of oral capsules at selected doses starting at 2 mg to 4 of the 6 participants within each cohort in Part A and Part B. For Part A, dosing frequency is one single dose on one occasion and for Part B, dosing frequency is single doses once daily for 14 days. If required, following dose escalation data review, dosing frequency and duration may be modified in Part B.~All participants in Part C (24) will receive active RXC007 in the form of oral capsules as single doses."

DRUG

RXC007 Matching Placebo

"The matching placebo for RXC007 will be administered in the form of oral capsules matched to the number of active RXC007 capsules at each dose level to 2 of the 6 participants within each cohort in Part A and Part B. For Part A, dosing frequency is one placebo dose on one occasion and for Part B, dosing frequency is single placebo doses once daily for 14 days. If required, following dose escalation data review, dosing frequency and duration may be modified in Part B.~There is no placebo intervention for Part C of the study."

Trial Locations (1)

CF48 4DR

Simbec-Orion Clinical Pharmacology, Merthyr Tydfil

All Listed Sponsors
collaborator

Simbec Research

INDUSTRY

lead

Redx Pharma Ltd

INDUSTRY