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

NCT ID: NCT02690727

Last Updated: 2017-11-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Keywords

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Fasting Fed condition Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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RP6530 in fast condition

A single dose of RP6530 following fast condition

Group Type EXPERIMENTAL

RP6530

Intervention Type DRUG

Single oral dose

RP6530 in fed condition

A single dose of RP6530 following fed condition

Group Type EXPERIMENTAL

RP6530

Intervention Type DRUG

Single oral dose

Interventions

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RP6530

Single oral dose

Intervention Type DRUG

Other Intervention Names

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A dual PI3K delta/gamma inhibitor

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rhizen Pharmaceuticals SA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Sicard, M.D

Role: PRINCIPAL_INVESTIGATOR

Algorithme Pharma Inc

Locations

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Algorithme Pharma Inc

Québec, , Canada

Site Status

Countries

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Canada

Other Identifiers

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ISI-P5-416

Identifier Type: OTHER

Identifier Source: secondary_id

RP6530-1501

Identifier Type: -

Identifier Source: org_study_id