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

March 11, 2014 updated by: Chronos Therapeutics Ltd

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 6 days post dose

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chronos Therapeutics Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

December 16, 2013

First Submitted That Met QC Criteria

December 19, 2013

First Posted (Estimate)

December 20, 2013

Study Record Updates

Last Update Posted (Estimate)

March 12, 2014

Last Update Submitted That Met QC Criteria

March 11, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RDC5-1-01
  • 2013-003335-29 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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