To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers
An Open Label, Randomized, Single Dose, Cross Over Study to Evaluate Food Effects on Relative Bioavailability of RP6530 Administered in Fasting and Fed Conditions in Healthy Volunteers
2 other identifiers
interventional
18
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy
Started Feb 2016
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 15, 2016
CompletedFirst Posted
Study publicly available on registry
February 24, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedResults Posted
Study results publicly available
June 16, 2017
CompletedNovember 28, 2017
February 1, 2016
29 days
February 15, 2016
December 15, 2016
November 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))
Pharmacokinetic parameters (Area under the plasma concentration versus time curve (AUC)) AUC0-T of RP6530 in fed and fast state.
up to 24 hours post-dose.
Secondary Outcomes (2)
Number of Participants Who Were Evaluated for Adverse Events
7 days
Pharmacokinetic Parameters
up to 24 hours post-dose.
Study Arms (2)
RP6530 in fast condition
EXPERIMENTALA single dose of RP6530 following fast condition
RP6530 in fed condition
EXPERIMENTALA single dose of RP6530 following fed condition
Interventions
Single oral dose
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Algorithme Pharma Inc
Québec, H3P 3P1, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Eric Sicard
- Organization
- Algorithme Pharma Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Eric Sicard, M.D
Algorithme Pharma Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2016
First Posted
February 24, 2016
Study Start
February 1, 2016
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
November 28, 2017
Results First Posted
June 16, 2017
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share