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CompletedNCT02016742Updated Mar 12, 2014

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

A Phase 1 interventional study of RDC5 in Healthy Volunteers, sponsored by Chronos Therapeutics Ltd. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-03-12.

Sponsored by Chronos Therapeutics Ltd · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study 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

Read the 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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Pharmacokinetics
03

In context

Lead sponsor

This is the only study on the registry with Chronos Therapeutics Ltd as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Willing to use effective method of contraception
  • Non smoker or ex-smoker within the previous 6 months

Exclusion criteria

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
05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • 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

Interventions

  • DrugRDC5
06

What researchers measure

Primary outcomes

  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 outcomes

  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

07

Study locations

1 site
  • Simbec Research Ltd
    Merthyr Tydfil, CF48 4DR, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02016742
Lead sponsor
Chronos Therapeutics Ltd
Responsible party
Sponsor
First posted
Dec 20, 2013
Start date
Dec 2013
Primary completion
Feb 2014
Completion
Feb 2014
Last update
Mar 12, 2014

Study contacts

Girish Sharma
principal investigator · Simbec Research

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.

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