A Phase 1 Study of the Pharmacokinetics of RDC5 in Healthy Volunteers
- Registration Number
- NCT02016742
- Lead Sponsor
- Chronos Therapeutics Ltd
- Brief Summary
The purpose of this study is to characterise the pharmacokinetics, safety and tolerability of RDC5 given as a single dose to healthy volunteers at a number of different dose levels
- Detailed Description
This is an open-label, randomised, single dose, 3-way crossover study to characterise and compare the PK, safety and tolerability of RDC5 in 15 healthy male volunteers. Eligible subjects will undergo 3 Treatment Periods, each separated by a washout period at least 14 days. Subjects will receive a single dose of RDC5 during each of the three Treatment Periods in line with their randomized treatment sequence. A total of 4 dose levels will be evaluated within the study, though each subject will only receive 3 doses. A Data Review Team (DRT) will review the pharmacokinetic (PK) data from Treatment Periods 1 and 2 and select the doses to be evaluated in Treatment Periods 2 and 3. Subjects will return for a follow visit 21 days after the last dose of RDC5.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 15
- Willing to use effective method of contraception
- Non smoker or ex-smoker within the previous 6 months
- History or presence of any clinically significant findings upon screening
- Participation in a New Chemical Entity clinical study within the previous 124 days or a marketed drug clinical study within the previous 93 days
- Positive result for human immunodeficiency virus (HIV) and/or hepatitis B or C test
- Positive result for urine alcohol and drug screen
- Blood donation ≥ 450 mL in the previous 12 weeks
- Receipt of prescription medicines and/or St John's Wort in the previous 2 weeks
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description RDC5 dose level 1 RDC5 Single dose of RDC5 RDC5 dose level 2 RDC5 Single dose of RDC5 RDC5 dose level 3 RDC5 Single dose of RDC5 RDC5 dose level 4 RDC5 Single dose of RDC5
- Primary Outcome Measures
Name Time Method Area under the concentration-time curve from time 0 to infinity (AUC0-inf) for the whole blood concentration of RDC5 Up to 6 days post dose
- Secondary Outcome Measures
Name Time Method AUC from time 0 to time of last observed concentration (AUC0-t) Up to 6 days post dose Maximum observed concentration (Cmax) Up to 6 days post dose Time at which Cmax occurred (tmax) Up to 6 days post dose Elimination half-life (t1/2) Up to 6 days post dose Terminal phase elimination rate constant (λz) Up to 6 days post dose Apparent volume of distribution (Vd/F) Up to 6 days post dose Apparent oral clearance (CL/F) Up to 6 days post dose Number (%) healthy volunteers with treatment emergent adverse events (AEs) 10 weeks
Trial Locations
- Locations (1)
Simbec Research Ltd
🇬🇧Merthyr Tydfil, United Kingdom