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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02016742
• Other study ID #: RDC5-1-01
• Secondary ID: 2013-003335-29
• Status: Completed
• Phase: Phase 1
• First received: December 16, 2013
• Last updated: March 11, 2014
• Start date: December 2013
• Est. completion date: February 2014

Study information

• Verified date: March 2014
• Source: Chronos Therapeutics Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• RDC5

Locations

Country	Name	City	State
United Kingdom	Simbec Research Ltd	Merthyr Tydfil

Sponsors (1)

Lead Sponsor	Collaborator
Chronos Therapeutics Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	AUC from time 0 to time of last observed concentration (AUC0-t)		Up to 6 days post dose	No
Secondary	Maximum observed concentration (Cmax)		Up to 6 days post dose	No
Secondary	Time at which Cmax occurred (tmax)		Up to 6 days post dose	No
Secondary	Elimination half-life (t1/2)		Up to 6 days post dose	No
Secondary	Terminal phase elimination rate constant (?z)		Up to 6 days post dose	No
Secondary	Apparent volume of distribution (Vd/F)		Up to 6 days post dose	No
Secondary	Apparent oral clearance (CL/F)		Up to 6 days post dose	No
Secondary	Number (%) healthy volunteers with treatment emergent adverse events (AEs)		10 weeks	Yes