Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Phase 1 Study of the Pharmacokinetics of RDC5 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02016742
Recruitment Status : Completed
First Posted : December 20, 2013
Last Update Posted : March 12, 2014
Sponsor:
Information provided by (Responsible Party):
Chronos Therapeutics Ltd

Tracking Information
First Submitted Date  ICMJE December 16, 2013
First Posted Date  ICMJE December 20, 2013
Last Update Posted Date March 12, 2014
Study Start Date  ICMJE December 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
Area under the concentration-time curve from time 0 to infinity (AUC0-inf) for the whole blood concentration of RDC5 [ Time Frame: Up to 6 days post dose ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02016742 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2013)
  • AUC from time 0 to time of last observed concentration (AUC0-t) [ Time Frame: Up to 6 days post dose ]
  • Maximum observed concentration (Cmax) [ Time Frame: Up to 6 days post dose ]
  • Time at which Cmax occurred (tmax) [ Time Frame: Up to 6 days post dose ]
  • Elimination half-life (t1/2) [ Time Frame: Up to 6 days post dose ]
  • Terminal phase elimination rate constant (λz) [ Time Frame: Up to 6 days post dose ]
  • Apparent volume of distribution (Vd/F) [ Time Frame: Up to 6 days post dose ]
  • Apparent oral clearance (CL/F) [ Time Frame: Up to 6 days post dose ]
  • Number (%) healthy volunteers with treatment emergent adverse events (AEs) [ Time Frame: 10 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 1 Study of the Pharmacokinetics of RDC5 in Healthy Volunteers
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE Drug: RDC5
Study Arms  ICMJE
  • Experimental: RDC5 dose level 1
    Single dose of RDC5
    Intervention: Drug: RDC5
  • Experimental: RDC5 dose level 2
    Single dose of RDC5
    Intervention: Drug: RDC5
  • Experimental: RDC5 dose level 3
    Single dose of RDC5
    Intervention: Drug: RDC5
  • Experimental: RDC5 dose level 4
    Single dose of RDC5
    Intervention: Drug: RDC5
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 19, 2013)
15
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02016742
Other Study ID Numbers  ICMJE RDC5-1-01
2013-003335-29 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chronos Therapeutics Ltd
Study Sponsor  ICMJE Chronos Therapeutics Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Girish Sharma Simbec Research
PRS Account Chronos Therapeutics Ltd
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP