CompletedPhase 1

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

United Kingdom90 participantsStarted 2021-05-13

Plain-language summary

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

Who can participate

Age range18 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy male participants, between 18 and 55 years of age, inclusive.
✓. 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/NIMP.
✓. Participant with a body mass index (BMI) of 18.0-32.0 kg/m2.
✓. Participant with a body weight of 60 kg or greater.
✓. No clinically significant history of previous allergy / sensitivity to RXC007, rosuvastatin or metformin, or any of the excipients contained within the IMP/NIMP.
✓. 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/NIMP.
✓. Haemoglobin and haematocrit above the lower limit of the normal range for the reference laboratory.
✓. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \< 1.5 times the upper limit of the normal (ULN) range for the reference laboratory.

Exclusion criteria

✕. A clinically significant history of gastrointestinal disorder likely to influence IMP/NIMP absorption.
✕. A clinically significant history of infection in the last 3 months.
✕. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements, antacids (Part C Cohort 1 only), 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/NIMP.
✕. Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
✕. 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).
✕. Participant with a glomerular filtration rate less than 80 mL/min/1.73m2 (calculated by Cockcroft-Gault equation.
✕. 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.
✕. Inability to communicate well with the Investigators (i.e., language problem, poor mental development or impaired cerebral function).

What they're measuring

Treatment Emergent Adverse Events

Timeframe: Collection of TEAEs occurs through ad hoc reporting from the participants from the point of first dose administration (Day 1 in each part) through to study completion (up to 6 weeks for Part A & up to 8 weeks for Part B & C).

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.

Timeframe: Part A: From Day 1 to post-study follow up visit (up to 6 weeks) & Part B/C: From Day 1 to post-study follow up visit (up to 8 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 post-study follow up visit.

Timeframe: Part A: From Day 1 to post-study follow up visit (up to 6 weeks) & Part B/C: From Day 1 to post-study follow up visit (up to 8 weeks)

Number of participants who report a change from normal range values for any of the associated 12-Lead ECG parameters (heart rate, PR interval, QRS width, QT interval and QTcF interval) from first dose on Day 1 to post-study follow up visit.

Timeframe: Part A: From Day 1 to post-study follow up visit (up to 6 weeks) & Part B/C: From Day 1 to post-study follow up visit (up to 8 weeks)

Trial details

NCT IDNCT04931147

SponsorRedx Pharma Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-08

View on ClinicalTrials.gov More Fibrosis trials

Who can participate

Age range18 Years – 55 Years

SexMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Healthy male participants, between 18 and 55 years of age, inclusive.
✓. 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/NIMP.
✓. Participant with a body mass index (BMI) of 18.0-32.0 kg/m2.
✓. Participant with a body weight of 60 kg or greater.
✓. No clinically significant history of previous allergy / sensitivity to RXC007, rosuvastatin or metformin, or any of the excipients contained within the IMP/NIMP.
✓. 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/NIMP.
✓. Haemoglobin and haematocrit above the lower limit of the normal range for the reference laboratory.
✓. Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) \< 1.5 times the upper limit of the normal (ULN) range for the reference laboratory.

Exclusion criteria

✕. A clinically significant history of gastrointestinal disorder likely to influence IMP/NIMP absorption.
✕. A clinically significant history of infection in the last 3 months.
✕. Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements, antacids (Part C Cohort 1 only), 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/NIMP.
✕. Evidence of renal, hepatic, central nervous system, respiratory, cardiovascular or metabolic dysfunction.
✕. 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).
✕. Participant with a glomerular filtration rate less than 80 mL/min/1.73m2 (calculated by Cockcroft-Gault equation.
✕. 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.
✕. Inability to communicate well with the Investigators (i.e., language problem, poor mental development or impaired cerebral function).

What they're measuring

Treatment Emergent Adverse Events

Timeframe: Part A: From Day 1 to post-study follow up visit (up to 6 weeks) & Part B/C: From Day 1 to post-study follow up visit (up to 8 weeks)