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

C

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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