A first in human study of RXC007 in healthy volunteers
Research type
Research Study
Full title
A randomised, double-blind, placebo-controlled, single-ascending and multiple ascending dose, first-in-human, phase 1 study to evaluate the safety, tolerability and pharmacokinetics of RXC007 as a monotherapy followed by evaluation of potential interactions with rosuvastatin, metformin and food in healthy male participants.
IRAS ID
293180
Contact name
Annelize Koch
Contact email
Sponsor organisation
Redx Pharma Plc
Eudract number
2020-006043-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 months, 22 days
Research summary
Summary of Research
The purpose of this study is to investigate RXC007.The objectives of this study are:
- To determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of RXC007 when it is administered as single and multiple doses at different dose strengths over a period of up to 14 days.- To investigate the concentration of RXC007 in the blood, how this changes over a period of time and to evaluate whether there are differences in the concentration between different dose strengths over time and between single or multiple doses.
- To investigate the effect of food on the concentration of RXC007 in the blood and to investigate if there any effects/interactions between RXC007 and 2 other drugs (rosuvastatin and metformin).
This study will be split into 3 parts: Parts A, B & C.
Part A and Part B will investigate RXC007 when it is given as a single dose on one occasion (Part A) and a single dose once a day for up to 14 days (Part B) at different dose strengths. In addition, one group in Part A will investigate the effect of food on RXC007. Part A will enrol 6 planned groups of 6 participants and Part B will enrol 2 planned groups of 6 participants.
Part C will investigate drug-drug interactions (DDI) between RXC007 and 2 other drugs; rosuvastatin (a drug used to lower cholesterol) and metformin (a drug which is used to treat type 2 diabetes). Part C will consist of 2 groups of participants; Group 1 will investigate DDI between rosuvastatin and RXC007 and Group 2 will investigate DDI between metformin and RXC007.
Blood samples will be taken at set time points to measure the concentration profile of RXC007 in the blood, how this changes over time and how this compares between each study group.
Summary of Results
The purpose of this study was to investigate the study drug RXC007. The main objectives of this study were as follows:- To determine the safety and tolerability (degree to which side effects of a drug can be tolerated) of RXC007 when it was administered as single and multiple doses at different dose strengths over a period of up to 14 days (Part A & Part B).
- To investigate the concentration of RXC007 in the blood, how this changed over a period of time and to evaluate whether there were differences in the concentration between different dose strengths over time and between single or multiple doses (Part A & Part B).
- To investigate the effect of food on the concentration of RXC007 in the blood (Part A).
- To investigate if there were any effects/interactions between RXC007 and 2 other drugs, to evaluate how these interactions affected the safety, tolerability and concentration of RXC007 in the blood and to determine how RXC007 affected the safety, tolerability and concentration of rosuvastatin (a drug used to lower cholesterol) and metformin (a drug used to treat Type 2 Diabetes) in the blood (Part C).
As well as evaluating the above, the study also evaluated, as exploratory objectives, the effect of RXC007 on the body (known as pharmacodynamics) by analysing the levels of certain biomarkers in the body (applied to Part B only) and also measured the levels of RXC007 in the urine to evaluate how much of RXC007 was removed from the body in urine (applied to Part A & Part B only). This study was split into 3 separate parts: Part A, Part B & Part C.
During the study, participants either received RXC007 or a placebo (which contained no active drug). Both RXC007 and the placebo were administered in the form of one or more capsules. Blood samples were taken at set time points throughout the study in order to measure the concentration profile of RXC007 in the blood. In terms of the overall study, the results from each of the groups in each study part and between each study part have been analysed to determine if there are any significant differences in the safety profile of RXC007, the concentration of RXC007 in the blood, how this changed over time and whether there were any differences between different dose strengths, single and multiple doses, taking the drug with or without food (food effect) or taking the drug in combination with other drugs (drug-drug interactions). The purpose of the data generated in this study was to provide further information and guidance to support the study sponsor in the development of the study drug RXC007.
With respect to the safety objectives of the study, it was determined that RXC007 was considered to be safe and well tolerated across all dose strengths evaluated during the study (inclusive of up to 100 mg once daily and 70 mg twice a day for 14 days) and when administered alone versus in combination with rosuvastatin and metformin. All of the reported side effects in the study were considered to be mild to moderate in severity and resolved within 1 day or less following reporting. In addition, the majority of effects were considered to not be related to the study drug and resolved without treatment (other than administration of paracetamol and ibuprofen where required).
With respect to the other objectives of the study, the following outcomes were reported:
- The data suggests that the concentration of RXC007 and how this changes over time is unaffected when RXC0007 is administered with or without food.
- RXC007 has shown some drug-drug interaction potential following evaluation of co-administration with rosuvastatin and metformin and therefore, in future studies of RXC007 in patients, caution should be advised if patients are also taking these drugs, in addition to other drugs which are broken down in the body via the same pathway as rosuvastatin and metformin.
- The data generated during the study for the concentrations of RXC007 in the blood have shown sufficient evidence for selection of doses in future studies in patients with the condition that RXC007 is being developed to treat and supported the identification of which doses are likely to have the most therapeutic benefit in treatment.
In summary, the data gathered during the study was considered sufficient to meet the objectives of the study and warrant further studies and investigations of the study drug.
REC name
Wales REC 2
REC reference
21/WA/0069
Date of REC Opinion
12 Mar 2021
REC opinion
Favourable Opinion