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

October 17, 2023 updated by: Redx Pharma Plc

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Wien, Austria, 1090
        • Not yet recruiting
        • Medical University of Vienna
        • Contact:
        • Principal Investigator:
          • Marko Idzko, MD
  • Belgium
      • Leuven, Belgium, 3000
      • Liège, Belgium, 4000
        • Recruiting
        • CHU de Liège
        • Contact:
        • Contact:
        • Principal Investigator:
          • Julien Guiot, MD
  • Czechia
      • Praha, Czechia, 140 59
        • Recruiting
        • Pneumologicka klinika 1.LF UK a
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martina Sterclova, MD
  • Italy
      • Ancona, Italy, 60126
        • Recruiting
        • Azienda Ospedaliero-Universitaria "Ospedali-Riuniti" di Ancona
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martina Bonifazi, MD
      • Catania, Italy, 95123
        • Recruiting
        • Azienda Ospedaliero Universitaria Policlinico ''G.Rodolico-San Marco''
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carlo Vancheri, MD
      • Foggia, Italy, 71122
        • Recruiting
        • Colonello D'avanzo Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Donato Lacedonia, MD
      • Lecce, Italy, 73100
        • Recruiting
        • PO Vito Fazzi
        • Contact:
        • Contact:
        • Principal Investigator:
          • Roberto Giaffreda, MD
      • Milan, Italy, 20123
        • Recruiting
        • Ospedale S. Giuseppe Milano
        • Principal Investigator:
          • Sergio Harari, MD
        • Contact:
      • Modena, Italy, 41124
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario A. Gemelli
        • Contact:
          • Luca Richeldi, MD
          • Phone Number: +39 0630157857
        • Contact:
        • Principal Investigator:
          • Luca Richeldi, MD
      • Verona, Italy, 37126
        • Recruiting
        • Azienda Ospedaliera Universitaria Integrata Verona
        • Contact:
        • Contact:
        • Principal Investigator:
          • Claudio Micheletto, MD
  • Poland
      • Gdansk, Poland, 01-138
        • Not yet recruiting
        • University Clinical Centre in Gdansk
        • Principal Investigator:
          • Alicja Siemińska, MD
        • Contact:
      • Lodz, Poland
      • Warsaw, Poland, 01-138
        • Not yet recruiting
        • Institute of Tuberculosis and Lung Diseases in Warsaw
        • Contact:
        • Principal Investigator:
          • Witold Tomkowski, MD
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Universitario Clinic de Barcelona
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jacobo Sellares, MD
      • Barcelona, Spain, 08006
        • Recruiting
        • Policlinica Barcelona
        • Contact:
          • Juan Roldán Sánchez, MD
          • Phone Number: +34 627 94 28 76
        • Contact:
        • Principal Investigator:
          • Juan Roldan Sanchez, MD
      • Barcelona, Spain, 08907
      • Madrid, Spain, 28046
        • Recruiting
        • Hospital Universitario La Paz
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carlos Segura, MD
      • Oviedo, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
          • Miguel Arias Guillén, MD
          • Phone Number: 37781 +34 985108000
        • Principal Investigator:
          • Miguel Arias Guillen, MD
        • Contact:
      • Santander, Spain, 39008
        • Recruiting
        • Hospital Universitario Marques de Valdecilla
        • Contact:
        • Contact:
        • Principal Investigator:
          • José Manuel Cifrián Martínez, MD
      • Santiago De Compostela, Spain, 15706
        • Recruiting
        • Hospital Clinico Universitario de Santiago de Compostela
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Suarez Antelo, MD
  • Switzerland
      • Geneva, Switzerland
        • Not yet recruiting
        • University Hospital of Geneve
        • Principal Investigator:
          • Anne Bergeron, MD
        • Contact:
  • United Kingdom
      • Belfast, United Kingdom, BT97AB
      • Birmingham, United Kingdom, B15 2GW
      • Cambridge, United Kingdom, CB2 0AY
        • Recruiting
        • Royal Papworth Hospital NHSFT
        • Contact:
        • Principal Investigator:
          • Helen Parfrey, MD
        • Contact:
      • Edinburgh, United Kingdom, EH16 4SA
      • London, United Kingdom, SE1 9RT
      • London, United Kingdom, SW3 6HP
        • Recruiting
        • Royal Brompton Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Philip Molyneaux, MD
      • Londonderry, United Kingdom, BT476SB
      • Oxford, United Kingdom, OX7 3LE
        • Recruiting
        • Churchill Hospital, Oxford University Hospitals NHS Trust
        • Contact:
        • Principal Investigator:
          • Peter Saunders, MD
        • Contact:
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Not yet recruiting
        • University of Southern California - Center for Advanced Lung Disease
        • Principal Investigator:
          • Toby Maher, MD
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Not yet recruiting
        • Temple University, Dept of Thoracic Medicine & Surgery (TMS)
        • Principal Investigator:
          • Gerard Criner, MD
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

38 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged ≥40 to 80 years at the time of signing the informed consent.
  • Diagnosis of IPF within 5 years of Screening based on the modified ATS/ERS/JRS/ALAT IPF guidelines for diagnosis and management of IPF (Raghu et al, 2018) and confirmed on independent central imaging review.
  • Combination of HRCT pattern, as assessed by central reviewers, consistent with diagnosis of IPF (see the modified ATS/ERS/JRS/ALAT IPF guidelines [Raghu et al, 2018]).
  • FVC % predicted ≥50% predicted of normal at Screening, with no clinically significant deterioration between the Screening Visit and randomisation, as determined by the Investigator.
  • DLco (Hb-adjusted) at screening ≥30%.
  • In the main study, participants receiving treatment for IPF with nintedanib or pirfenidone are allowed if on treatment for at least 3 months and on a stable dose for at least 4 weeks prior to Screening and during Screening.
  • In patients who are not on any treatment for IPF but have previously received nintedanib or pirfenidone, there needs to be a washout period ≥4 weeks prior to Screening.
  • No clinically significant abnormalities, in the opinion of the investigator, in vital signs (e.g., blood pressure, pulse rate, respiration rate, oral temperature) within 28 days before first dose of IMP.

Exclusion Criteria:

  • Currently receiving or planning to initiate treatment for IPF with agents not approved for that indication.
  • FEV1/FVC ratio <0.7 at Screening, pre-bronchodilator use.

  • Lower respiratory tract infection requiring antibiotics within 4 weeks of Screening or during Screening.

    4. The extent of emphysema in the lungs exceeds fibrosis, based on central review of HRCT scans.

  • Need for continuous oxygen supplementation, defined as >15 hours/day.
  • Acute IPF exacerbation within 6 months of Screening or during Screening.
  • Clinical diagnosis of any connective-tissue disease (including, but not limited to, scleroderma, polymyositis/dermatomyositis, systemic lupus erythematosus, and rheumatoid arthritis) or a diagnosis of interstitial pneumonia with autoimmune features as determined by the Investigator applying the recent ERS/ATS research statement [Fischer et al 2015]. Note: Serological testing is not needed if not clinically indicated.
  • Disease other than IPF with a life expectancy of less than 12 weeks.

Additional exclusion criteria for the Translational Science Sub Study

  • Participants with any contra-indication to bronchoscopy and alveolar lavage including tracheal stenosis, pulmonary hypertension, severe hypoxia, or hypercapnia.
  • Patients in the sub study are not permitted to receive nintedanib or pirfenidone within 3 weeks of randomisation and throughout the Treatment period. (Note: background IPF treatment should not be stopped for the purpose of eligibility)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
12:4 (RXC007 : Placebo) Dose level 1: 12 weeks (84 days) dosing
Drug: RXC007
RXC007 will be administered in the form of oral capsules at 3 dose levels: 20 mg, 50mg and 70 mg in 5 cohorts. 12 patients of cohorts 1, 2 and 3 will receive RXC007 and 6 patients of cohorts 1B and 3B. 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 3. In Cohorts 1B and 3B, the placebo will be received by 2 of the 8 patients. The Dosage regimen is BID or QD
Experimental: Cohort 2
12:4 (RXC007 : Placebo) Dose level 2: 12 weeks (84 days) dosing
Drug: RXC007
RXC007 will be administered in the form of oral capsules at 3 dose levels: 20 mg, 50mg and 70 mg in 5 cohorts. 12 patients of cohorts 1, 2 and 3 will receive RXC007 and 6 patients of cohorts 1B and 3B. 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 3. In Cohorts 1B and 3B, the placebo will be received by 2 of the 8 patients. The Dosage regimen is BID or QD
Experimental: Cohort 3
12:4 (RXC007 : Placebo) Dose level 3: 12 weeks (84 days) dosing
Drug: RXC007
RXC007 will be administered in the form of oral capsules at 3 dose levels: 20 mg, 50mg and 70 mg in 5 cohorts. 12 patients of cohorts 1, 2 and 3 will receive RXC007 and 6 patients of cohorts 1B and 3B. 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 3. In Cohorts 1B and 3B, the placebo will be received by 2 of the 8 patients. The Dosage regimen is BID or QD
Experimental: Cohort 1B
6:2 (RXC007 : Placebo) Dose level 1; 12 weeks (28 days) dosing, Pre- and on-treatment bronchoscopy
Drug: RXC007
RXC007 will be administered in the form of oral capsules at 3 dose levels: 20 mg, 50mg and 70 mg in 5 cohorts. 12 patients of cohorts 1, 2 and 3 will receive RXC007 and 6 patients of cohorts 1B and 3B. 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 3. In Cohorts 1B and 3B, the placebo will be received by 2 of the 8 patients. The Dosage regimen is BID or QD
Experimental: Cohort 3B
6:2 (RXC007 : Placebo) Dose level 3; 12 weeks (28 days) dosing, Pre- and on-treatment bronchoscopy
Drug: RXC007
RXC007 will be administered in the form of oral capsules at 3 dose levels: 20 mg, 50mg and 70 mg in 5 cohorts. 12 patients of cohorts 1, 2 and 3 will receive RXC007 and 6 patients of cohorts 1B and 3B. 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 3. In Cohorts 1B and 3B, the placebo will be received by 2 of the 8 patients. The Dosage regimen is BID or QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of AEs and SAEs Changes in safety laboratory parameters, vital signs, and ECGs
Time Frame: From Day 1 to post-study follow up visit (12 weeks)
The primary endpoints of the study include the incidence and severity of AEs and SAEs
From Day 1 to post-study follow up visit (12 weeks)
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.
Time Frame: From Day 1 to post-study follow up visit (12 weeks)
This primary endpoint will report the number of participants within all cohorts of study who record a value which is deemed as outside of the normal range (regardless of clinical significance) for any of the serum biochemistry, serum haematology or urinalysis parameters as defined in the study protocol following first dose administration on Day 1 up to completion of the post-study visit
From Day 1 to post-study follow up visit (12 weeks)
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 12 weeks of treatment
Time Frame: From Day 1 to post-study follow up visit (12 weeks)
This primary endpoint will report the number of participants within all cohorts of the study who record a value which is deemed as outside of the normal range (regardless of clinical significance) for any of the vital signs parameters (systolic/diastolic blood pressure, pulse rate, respiration rate, oral body temperature) as defined in the study protocol following first dose administration on Day 1 up to completion of the post-study visit
From Day 1 to post-study follow up visit (12 weeks)
Number of participants who report a change from normal range values for any of the associated 12-Lead ECG parameters (heart rate, QT interval and QTcF interval) from first dose on Day 1 up to completion of the post-study visit.
Time Frame: From Day 1 to post-study follow up visit (12 weeks)
This primary endpoint will report the number of participants within all cohorts of the study who record a value which is deemed as outside of the normal range (regardless of clinical significance) for any of the 12-Lead ECG parameters (heart rate, QT interval and QTcF interval) as defined in the study protocol following first dose administration on Day 1 up to 12 weeks of treatment
From Day 1 to post-study follow up visit (12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic Parameters - Maximum plasma concentration (Cmax)
Time Frame: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the maximum observed concentration (Cmax) of RXC007 in plasma for all cohorts.
For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Minimum observed plasma concentration (Cmin)
Time Frame: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the minimum observed concentration (Cmin) of RXC007 in plasma for all cohorts.
For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Pharmacokinetic Parameters - Time to maximum observed concentration (Tmax)
Time Frame: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the time to maximum observed concentration (Tmax) of RXC007 in plasma for all cohorts.
For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Pharmacokinetic Parameters - Terminal elimination half-life (t1/2)
Time Frame: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the terminal elimination half-life (t1/2) of RXC007 in plasma for all cohorts
For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Pharmacokinetic Parameters - Elimination rate constant (λz)
Time Frame: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the elimination rate constant (λz) of RXC007 in plasma for all cohorts.
For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Pharmacokinetic Parameters - Area under the concentration-time curve (AUC) extrapolated to infinity (AUC0-inf)
Time Frame: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the area under the concentration-time curve (AUC) extrapolated to infinity (AUC0-inf) of RXC007 in plasma for all cohorts.
For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Pharmacokinetic Parameters - Total apparent clearance following extravascular administration (CL/F)
Time Frame: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the total apparent clearance following extravascular administration (CL/F) of RXC007 in plasma for all cohorts.
For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Pharmacokinetic Parameters - Apparent volume of distribution following extravascular administration (Vz/F)
Time Frame: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the apparent volume of distribution following extravascular administration (Vz/F) of RXC007 in plasma for all cohorts.
For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Pharmacokinetic Parameters - Area under the plasma concentration-time curve during a dosing interval at steady state (AUCss)
Time Frame: For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
Plasma samples will be obtained in order to evaluate defined plasma pharmacokinetic parameters for RXC007. This endpoint will report the summary of derived pharmacokinetic parameters for the area under the concentration-time curve (AUC) at steady state of RXC007 in plasma for all cohorts.
For Cycle1 Day1 pre-dose, 1, 2, 3, 4, 8 h post-dose. For Cycle1 Day8 pre-dose, 1, 2, 3, 4, 8 h post-dose for all BID schedules. If the schedule is changed to QD, for Cycle1 Day8 will include a 24 h post-dose sample (Cycle1 Day9). On Cycle2 Day1 pre-dose.
% predicted and absolute volume change from baseline in Forced Vital Capacity (FVC) at 12 weeks [central review]
Time Frame: At Screening (Day28 to Day-1), Cycle1 Day1 pre-dose and post-dose, Cycle1 Day8, Cycle1 Day15, Cycle1 Day22, Cycle2 Day1(The day after Cycle1 Day28), Cycle2 Day15, Cycle3 Day1, Cycle3 Day28, End Of Treatment: last day of the dosing Day 21
Information on Forced Vital Capacity (FVC) for the 6 months prior to study entry will be collected. Spirometry testing (without bronchodilator use) will be performed at all scheduled study visits in clinic. For each patient, spirometry testing should be conducted at approximately the same time of day.
At Screening (Day28 to Day-1), Cycle1 Day1 pre-dose and post-dose, Cycle1 Day8, Cycle1 Day15, Cycle1 Day22, Cycle2 Day1(The day after Cycle1 Day28), Cycle2 Day15, Cycle3 Day1, Cycle3 Day28, End Of Treatment: last day of the dosing Day 21
% predicted and absolute change from baseline in carbon monoxide diffusion capacity (DLCO)
Time Frame: At Screening (day28 to Day-1), Cycle1 Day1 pre-dose, Cycle1 Day15, Cycle2 Day1 (The day after Cycle1 Day28)
Carbon monoxide diffusion capacity will be measured in clinic
At Screening (day28 to Day-1), Cycle1 Day1 pre-dose, Cycle1 Day15, Cycle2 Day1 (The day after Cycle1 Day28)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Redx Pharma Plc

Collaborators

Simbec Research

Investigators

  • Principal Investigator: Philip Molyneaux, MD, Royal Brompton & Harefield NHS Foundation Trust
  • Principal Investigator: Toby Maher, MD, University of Southern California, USA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2022

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

September 28, 2022

First Submitted That Met QC Criteria

October 3, 2022

First Posted (Actual)

October 6, 2022

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 17, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RXC007/0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

At this stage, it is not planned that any IPD information will be shared with other researchers outside of the Sponsor and Clinical Research Organisation undertaking the conduct of this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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