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

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | 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:
- 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

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
United Kingdom | |
Simbec Research Ltd | |
Merthyr Tydfil, United Kingdom, CF48 4DR |
Principal Investigator: | Girish Sharma | Simbec Research |
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 |
Pharmacokinetics |