NCT05570058

Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of RXC007 in Idiopathic Pulmonary Fibrosis

A Multi-Cohort, Randomised, Placebo-Controlled Phase 2a Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of Ascending Doses of RXC007 in Patients With Idiopathic Pulmonary Fibrosis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Redx Pharma Ltd · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the safety and tolerability of RXC007 when given for 12 weeks (84 days), alone and in combination with nintedanib or pirfenidone.

Detailed description

The purpose of this study is to investigate the study drug RXC007. The main objectives of this study are as follows: * To determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of RXC007 when it is administered as twice daily doses over a period of up to 12 weeks (84 days). * To investigate the concentration of RXC007 (how much drug is in your blood), how this changes over a period of time and to evaluate whether there are differences in the concentration between different dose strengths of RXC007. * To investigate the effect of RXC007 on the body (known as pharmacodynamics) by analysing the levels of certain biomarkers in the body and to assess the effect of RXC007 on markers associated with Idiopathic Pulmonary Fibrosis (IPF). Biomarkers are markers within the body such as a molecule or compound made by cells in the body, which can be measured and used to identify a particular disease.

Conditions

• IPF
• Fibrosis

Interventions

Type	Name	Description
DRUG	RXC007	RXC007 will be administered in the form of oral capsules at 3 potential dose levels: 20 mg, 50mg and 70 mg in 5 cohorts. 12 patients of cohorts 1, 2 and the Expansion cohort will receive RXC007. The Dosage regimen is BID or QD.
DRUG	Placebo	The placebo will be administered in the form of oral capsules at each dose level to 4 of the 16 participants within cohorts 1, 2 and the Expansion cohort. The Dosage regimen is BID or QD

Timeline

• Start date: 2022-09-08
• Primary completion: 2024-06-25
• Completion: 2025-01-09
• First posted: 2022-10-06
• Last updated: 2024-08-23

Locations

31 sites across 8 countries: Austria, Belgium, Czechia, Italy, Poland, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study