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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of RXC007.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Redx Pharma Plc
• Collaborator: Simbec Research

Criteria

Inclusion Criteria:

1. Healthy male participants, between 18 and 55 years of age, inclusive.

2. Male participant (and female partner of childbearing potential) willing to use a highly effective method of contraception or 2 effective methods of contraception, if applicable (unless anatomically sterile or where abstaining from sexual intercourse is in line with the preferred and usual lifestyle of the participant) from first dose until 3 months after last dose of IMP.

3. Participant with a body mass index (BMI) of 18.0-32.0 kg/m2.

4. Participant with a body weight of 60 kg or greater.

5. No clinically significant history of previous allergy / sensitivity to RXC007 or any of the excipients contained within the IMP.

6. No clinically significant abnormal test results for serum biochemistry, haematology and/or urine analyses within 28 days before the first dose administration of the IMP.

7. Haemoglobin and haematocrit above the lower limit of the normal range for the reference laboratory.

8. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) < 1.5 times the upper limit of the normal (ULN) range for the reference laboratory.

9. Participant with a negative urinary drugs of abuse (DOA) screen (including alcohol) test results, determined within 28 days before the first dose administration of the IMP.

10. Participant with negative human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCV Ab) test results at Screening.

11. No clinically significant abnormalities in 12-lead electrocardiogram (ECG) determined within 28 days before first dose of IMP including a PR interval > 220ms, QRS width > 120ms and QTcF interval > 450 ms.

12. No clinically significant abnormalities in vital signs (e.g., blood pressure (systolic blood pressure > 140 mmHg) / pulse rate, respiration rate, oral temperature) determined within 28 days before first dose of IMP.

13. Participant must be available to complete the study (including all follow-up visits).

14. Participant must satisfy an Investigator about his fitness to participate in the study.

15. Participant must provide written informed consent to participate in the study.

16. Participants with a negative COVID-19 reverse transcription polymerase chain reaction (RT-PCR) test on admission (if required).

Exclusion Criteria:

1. A clinically significant history of gastrointestinal disorder likely to influence IMP absorption.

2. A clinically significant history of infection in the last 3 months.

3. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements, any product known to be a substrate mainly metabolised by CYP enzymes within 28 days or 5 half-lives (whichever is longer) prior to the first dose of IMP.

4. Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.

5. Participants who are unable to demonstrate the ability to swallow multiple "dummy" capsules (i.e., an empty gelatin capsules) of the size proposed for administration in a particular cohort/dose level (up to and including size 00).

6. Participant with a glomerular filtration rate less than 80 mL/min/1.73m2 (calculated by Cockcroft-Gault equation.

7. 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.

8. Inability to communicate well with the Investigators (i.e., language problem, poor mental development or impaired cerebral function).

9. Participation in a 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).

10. Donation of 450 mL or more blood within the 3 months before the first dose of IMP.

11. Vegans, vegetarians or other dietary restrictions (e.g., restrictions for medical, religious or cultural reasons, etc.), which would prevent participants from consuming a high-fat breakfast or standardised meal.

12. Users of nicotine products i.e., current smokers or ex-smokers who have smoked within the 6 months prior to first dose administration with the study medication or users of cigarette replacements (i.e., e-cigarettes, nicotine patches or gums).

13. Participants who have received a COVID-19 vaccine injection within 28 days prior to the first dose of IMP.