A Phase 1 Study of the Pharmacokinetics of RDC5 in Health... | NCT02016742

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

NCT02016742

Sponsor

Chronos Therapeutics Ltd

Status

Completed

Last Update Posted

Mar 12, 2014Estimated

Enrollment

15Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

RDC5

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2013-003335-29	EudraCT Number

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2013

Primary Completion Date

Feb 2014Actual

Completion Date

Feb 2014Actual

First Submitted Date

Dec 16, 2013

First Submission Date that Met QC Criteria

Dec 19, 2013

First Posted Date

Dec 20, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2014

Last Update Posted Date

Mar 12, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RDC5 dose level 1	Experimental	Single dose of RDC5	Drug: RDC5
RDC5 dose level 2	Experimental	Single dose of RDC5	Drug: RDC5
RDC5 dose level 3	Experimental	Single dose of RDC5	Drug: RDC5
RDC5 dose level 4	Experimental	Single dose of RDC5	Drug: RDC5

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RDC5	Drug		RDC5 dose level 1 RDC5 dose level 2 RDC5 dose level 3 RDC5 dose level 4

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Girish Sharma	Simbec Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Simbec Research Ltd		Merthyr Tydfil		CF48 4DR	United Kingdom