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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: RDC5


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RDC5 dose level 1<br>Single dose of RDC5 | Drug: RDC5<br> <br> |
| Experimental: RDC5 dose level 2<br>Single dose of RDC5 | Drug: RDC5<br> <br> |
| Experimental: RDC5 dose level 3<br>Single dose of RDC5 | Drug: RDC5<br> <br> |
| Experimental: RDC5 dose level 4<br>Single dose of RDC5 | Drug: RDC5<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the concentration-time curve from time 0 to infinity (AUC0-inf) for the whole blood concentration of RDC5 |  | Up to 6 days post dose | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics