To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers

R

Rhizen Pharmaceuticals

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: RP6530

Study type

Interventional

Funder types

Industry

Identifiers

NCT02690727
ISI-P5-416 (Other Identifier)
RP6530-1501

Details and patient eligibility

About

This is a single centre, open label, randomized, two-treatment, two-period, two-sequence, single dose crossover food effect study in 18 subjects. The subjects will receive the study medication under either fed or fast during each treatment period.

Full description

The present study will be conducted in healthy male volunteers. A single oral dose will be administered to the subject in each treatment period (under either fasting or fed state). Each treatment period will be separated by at least 7 calendar days. Post dose PK blood samples will be collected in each treatment period to evaluate the food effect on bioavailability of RP6530. The safety and tolerability of single dose will also be evaluated.

Enrollment

18 patients

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Healthy male volunteers; aged 18 to 45 years;
  • Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive, weight ≥ 50 kg;
  • Non- smokers or ex-smokers;
  • Able to give informed consent.

Exclusion criteria

  • Subjects with evidence or history of clinically significant disease;
  • Positive results to HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests;
  • Subjects who have received any investigational drug in the previous 28 days;
  • Subjects participated in a study with PI3k inhibitors at least once in past year;
  • Subjects who have received drugs metabolised by CYP3A4 enzyme in the previous 28 days.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

18 participants in 2 patient groups

RP6530 in fast condition
Experimental group
Description:
A single dose of RP6530 following fast condition
Treatment:
Drug: RP6530
RP6530 in fed condition
Experimental group
Description:
A single dose of RP6530 following fed condition
Treatment:
Drug: RP6530

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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