Healthy volunteers Other
Conditions
Interventions
This was a phase I, randomised, double blind, placebo-controlled study to assess the safety, tolerability, PK, PD/exploratory biomarkers of RXC008 in healthy participants following ascending single (P
Sponsors
Redx Pharma (United Kingdom)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Male between 18-50 years of age (extremes included), on the day of signing the informed consent form (ICF). 2. Participant with a body mass index (BMI) of 18-30kg/m². BMI = body weight (kg) / height (m)². 3. No clinically significant history of previous allergy / sensitivity to RXC008 or any of the excipients contained within the IMP. 4. No clinically significant abnormal test results for serum biochemistry, haematology and/or urine analyses within 35 days before the first dose administration of the IMP. 5. No clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 35 days before first dose of IMP including a PR interval > 220ms, QRS width > 120ms and QTcF interval > 450 ms. 6. No clinically significant abnormalities in vital signs (e.g., blood pressure (systolic blood pressure < 90 mmHg or diastolic blood pressure < 50mmHg) / heart rate, respiration rate, oral temperature) determined within 35 days before first dose of IMP. 7. Participant must be available to complete the study (including all follow-up visits). 8. Male participant (and partner of childbearing potential) willing to adhere to the contraceptive requirements in Section 10.6.1. 9. Participant must provide written informed consent to participate in the study. 10. Participant must be willing to comply with institutional COVID-19 testing policy. 11. Participant with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg)) and hepatitis C virus antibody (HCV Ab) test results at Screening. 12. Participant with a negative urinary drugs of abuse (DOA) screen (including alcohol) test results, determined within 35 days before the first dose administration of the IMP (N.B.: A positive test result may be repeated at the Investigator’s discretion). 13. Participant with a negative COVID-19 test on admission (if required). Part B Only 14. Participant must be considered fit to undergo two ileocolonoscopies, in the opinion of the Investigator.
Exclusion criteria
Exclusion criteria: 1. Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction. 2. A clinically significant history of drug or alcohol abuse (defined as the consumption of more than 14 units of alcohol a week) within the past two years. 3. Inability to communicate well with the Investigators (i.e., language problem, poor mental development or impaired cerebral function). 4. Prior treatment with RXC008. 5. Participation in a New Chemical Entity (NCE) clinical study within the previous 3 months or five half-lives, whichever is longer, or a marketed drug clinical study within the 30 days or five half-lives, whichever is longer, before the first dose of IMP. (Washout period between studies is defined as the period of time elapsed between the last dose of the previous study and the first dose of the next study). 6. Donation of 450 mL or more blood within the 3 months before the first dose of IMP. 7. Dietary restrictions that would prevent the subject from consuming a standardised meal or gelatine capsule. 8. Any concurrent illness, condition, disability, or clinically significant abnormality (including laboratory tests, or clinically significant illness in the three months prior to initial IMP administration) that, in the investigator's opinion, represents a safety risk participation in the study, may affect the interpretation of clinical safety or efficacy data, or may prevent the participant from safely completing the assessments required by the protocol. 9. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 35 days or 5 half-lives (whichever is longer) prior to the first dose of IMP. 10. Users of nicotine products i.e., current smokers or ex-smokers who have smoked within the 6 months prior to Screening or users of cigarette replacements (i.e., e-cigarettes, nicotine patches or gums). 11. Participants who are unable to demonstrate the ability to swallow multiple “dummy” capsules (i.e., empty gelatine capsules) of the size proposed for administration in a particular cohort/dose level (up to and including size 00).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The number of incidents of Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and discontinuations due to Adverse Events (AEs). 2. Laboratory safety (biochemistry, haematology, coagulation and urinalysis). 3. Vital signs (systolic/diastolic blood pressure [including ambulatory BP], heart rate, respiration rate, oral body temperature). 4. 12-lead ECG (heart rate, PR interval, QRS width, QT interval, QTcF interval). Timepoints for Assessment are as follows: Adverse Events & Serious Adverse Events - AEs & SAEs will be recorded from the point of informed consent up to final post-study follow up visit. Laboratory Safety Testing Part A: Set timepoints from Screening until Day 15 (end of study visit - applies to all treatment periods) Part B: Set timepoints from Screening until Day 28 (end of study visit) Vital Signs Part A: Set timepoints from Screening until Day 15 (end of study visit - applies to all treatment periods) Part B: Set timepoints from Screening until Day 28 (end of study visit) 12-Lead ECG Part A: Set timepoints from Screening until Day 15 (end of study visit - applies to all treatment periods) Part B: Set timepoints from Screening until Day 28 (end of study visit) | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters derived from analysis of plasma samples for concentrations of RXC008. Endpoints are defined as follows: PART A: 1. Plasma: Cmax, Tmax, AUC0-t PART B: 1. Plasma (Day 11/12 only): Cmax, Tmax, AUC0-t 2. Ileal and colon tissue: concentration only - C(n) Timepoints for Assessment are as follows: Plasma PK Sampling Part A: Set timepoints from Day 1 pre-dose until 24 hr post-dose (applies to all treatment periods) Part B: Set timepoints from Day 1 pre-dose until 24 hr post-dose & Day 11 pre-dose until 24 hr post-dose | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactHelen Timmis
Outcome results
None listed