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

Chronos Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: RDC5

Study type: Interventional

Funder types: Industry

Identifiers

NCT02016742

2013-003335-29 (EudraCT Number)

RDC5-1-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

15 participants in 4 patient groups

RDC5 dose level 1

Experimental group

Description:

Single dose of RDC5

Treatment:

Drug: RDC5

RDC5 dose level 2

Experimental group

Description:

Single dose of RDC5

Treatment:

Drug: RDC5

RDC5 dose level 3

Experimental group

Description:

Single dose of RDC5

Treatment:

Drug: RDC5

RDC5 dose level 4

Experimental group

Description:

Single dose of RDC5

Treatment:

Drug: RDC5