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

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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

Study Description
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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

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: RDC5 Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
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 Start Date : December 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014
Arms and Interventions
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Arm Intervention/treatment
Experimental: RDC5 dose level 1
Single dose of RDC5
 Drug: RDC5
Experimental: RDC5 dose level 2
Single dose of RDC5
 Drug: RDC5
Experimental: RDC5 dose level 3
Single dose of RDC5
 Drug: RDC5
Experimental: RDC5 dose level 4
Single dose of RDC5
 Drug: RDC5


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. AUC from time 0 to time of last observed concentration (AUC0-t) [ Time Frame: Up to 6 days post dose ]
  2. Maximum observed concentration (Cmax) [ Time Frame: Up to 6 days post dose ]
  3. Time at which Cmax occurred (tmax) [ Time Frame: Up to 6 days post dose ]
  4. Elimination half-life (t1/2) [ Time Frame: Up to 6 days post dose ]
  5. Terminal phase elimination rate constant (λz) [ Time Frame: Up to 6 days post dose ]
  6. Apparent volume of distribution (Vd/F) [ Time Frame: Up to 6 days post dose ]
  7. Apparent oral clearance (CL/F) [ Time Frame: Up to 6 days post dose ]
  8. Number (%) healthy volunteers with treatment emergent adverse events (AEs) [ Time Frame: 10 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016742


Locations
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United Kingdom
Simbec Research Ltd
Merthyr Tydfil, United Kingdom, CF48 4DR
Sponsors and Collaborators
Chronos Therapeutics Ltd
Investigators
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Principal Investigator: Girish Sharma Simbec Research
More Information
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Responsible Party: Chronos Therapeutics Ltd
ClinicalTrials.gov Identifier: NCT02016742    
Other Study ID Numbers: RDC5-1-01
2013-003335-29 ( EudraCT Number )
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: March 12, 2014
Last Verified: March 2014
Keywords provided by Chronos Therapeutics Ltd:
Pharmacokinetics