Clinical trial NCT02016742: A Phase 1 Study of the Pharmacokinetics of RDC5 in Healthy Volunteers
Official title: A Phase I, Open-label, Randomised, 3-way Crossover Study to Characterise and Compare the Pharmacokinetics, Safety and Tolerability of RDC5 Given as a Single Dose to Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Pharmacokinetics
Lead sponsor: Chronos Therapeutics Ltd
Sponsor class: INDUSTRY
First posted: 2013-12-20
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Area under the concentration-time curve from time 0 to infinity (AUC0-inf) for the whole blood concentration of RDC5
timeFrame: Up to 6 days post dose
Secondary outcomes:
measure: AUC from time 0 to time of last observed concentration (AUC0-t)
timeFrame: Up to 6 days post dose
measure: Maximum observed concentration (Cmax)
timeFrame: Up to 6 days post dose
measure: Time at which Cmax occurred (tmax)
timeFrame: Up to 6 days post dose
measure: Elimination half-life (t1/2)
timeFrame: Up to 6 days post dose
measure: Terminal phase elimination rate constant (λz)
timeFrame: Up to 6 days post dose
measure: Apparent volume of distribution (Vd/F)
timeFrame: Up to 6 days post dose
measure: Apparent oral clearance (CL/F)
timeFrame: Up to 6 days post dose
measure: Number (%) healthy volunteers with treatment emergent adverse events (AEs)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Merthyr Tydfil
country: United Kingdom
facility: Simbec Research Ltd
Study officials:
affiliation: Simbec Research
name: Girish Sharma
role: PRINCIPAL_INVESTIGATOR
References: