Healthy Volunteers
Conditions
Keywords
Pharmacokinetics
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.
Interventions
DRUGRDC5
Sponsors
Chronos Therapeutics Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Willing to use effective method of contraception * Non smoker or ex-smoker within the previous 6 months
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| AUC from time 0 to time of last observed concentration (AUC0-t) | 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 |
| Terminal phase elimination rate constant (λz) | Up to 6 days post dose |
Countries
United Kingdom
Outcome results
None listed