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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-02-28

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

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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RDC5 dose level 1

Single dose of RDC5

Group Type EXPERIMENTAL

RDC5

Intervention Type DRUG

RDC5 dose level 2

Single dose of RDC5

Group Type EXPERIMENTAL

RDC5

Intervention Type DRUG

RDC5 dose level 3

Single dose of RDC5

Group Type EXPERIMENTAL

RDC5

Intervention Type DRUG

RDC5 dose level 4

Single dose of RDC5

Group Type EXPERIMENTAL

RDC5

Intervention Type DRUG

Interventions

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RDC5

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes