NCT02016742

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 12, 2014

Status Verified

March 1, 2014

Enrollment Period

2 months

First QC Date

December 16, 2013

Last Update Submit

March 11, 2014

Conditions

Healthy Volunteers

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • 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 (8)

  • 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

  • +3 more secondary outcomes

Study Arms (4)

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

RDC5DRUG
RDC5 dose level 1RDC5 dose level 2RDC5 dose level 3RDC5 dose level 4

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Willing to use effective method of contraception
  • Non smoker or ex-smoker within the previous 6 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simbec Research Ltd

Merthyr Tydfil, CF48 4DR, United Kingdom

Location

Study Officials

  • Girish Sharma

    Simbec Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2013

First Posted

December 20, 2013

Study Start

December 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 12, 2014

Record last verified: 2014-03

Locations

GB(1)