Phase 1
N=18
To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT02690727 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC)) — 5277.01; 6726.99 nanogram*hour per millilitre (ng*h/mL) — p=0.0002
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- RP6530 (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Rhizen Pharmaceuticals SA
- Primary completion
- Mar 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC)) |
5277.01; 6726.99 | 0.0002 sig |
| SECONDARY Number of Participants Who Were Evaluated for Adverse Events |
16; 16 | — |
| SECONDARY Pharmacokinetic Parameters |
1311.77; 1753.78 | 0.0278 sig |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02690727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.