HealthyPhase 1NCT02690727
To Evaluate the Food Effect on Relative Bioavailability of RP6530 in Healthy Volunteers
A Phase 1 study testing RP6530 in people with Healthy, run by Rhizen Pharmaceuticals SA at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- RP6530
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2016to Mar 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed 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.
- Conditions
- Healthy
- Being tested
- RP6530
- Keywords
- Fasting, Fed condition, Pharmacokinetics
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RP6530Drug
Also called A dual PI3K delta/gamma inhibitor
Single oral dose
| Study group | Role | What they receive |
|---|---|---|
| RP6530 in fast condition | Experimental | A single dose of RP6530 following fast condition Receives: Drug: RP6530 |
| RP6530 in fed condition | Experimental | A single dose of RP6530 following fed condition Receives: Drug: RP6530 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 hours post-dose.
Secondary outcomes (2)
Number of Participants Who Were Evaluated for Adverse Events
Number of Participants Who Were Evaluated for Adverse Events as Assessed by CTCAE v4.0
Measured: 7 days
Pharmacokinetic Parameters
Peak Plasma Concentration (Cmax)
Measured: up to 24 hours post-dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhizen Pharmaceuticals SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Sicard, M.D, Principal investigator, Algorithme Pharma Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690727
- Sponsor's protocol ID
- RP6530-1501
- Other IDs
- ISI-P5-416
- Status last verified
- Feb 2016
- First submitted
- 15 Feb 2016
- Last updated
- 28 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02690727
- Acronym / sponsor ID
- RP6530-1501
- Conditions
- Healthy
- Keywords
- Fasting, Fed condition, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Rhizen Pharmaceuticals SAIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RP6530 in fast condition | Experimental | Drug: RP6530A single dose of RP6530 following fast condition |
| RP6530 in fed condition | Experimental | Drug: RP6530A single dose of RP6530 following fed condition |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RP6530Also: A dual PI3K delta/gamma inhibitorSingle oral dose | Drug | RP6530 in fast condition, RP6530 in fed condition |
Primary outcome
Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC))
Time frame: up to 24 hours post-dose.
Pharmacokinetic parameters (Area under the plasma concentration versus time curve (AUC)) AUC0-T of RP6530 in fed and fast state.
2 secondary outcomes
Number of Participants Who Were Evaluated for Adverse Events
Time frame: 7 days
Pharmacokinetic Parameters
Time frame: up to 24 hours post-dose.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Sicard, M.D principal investigator
Algorithme Pharma Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RP6530 in people with Healthy, run by Rhizen Pharmaceuticals SA at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Parameters (Area Under the Plasma Concentration Versus Time Curve (AUC)) (time frame: up to 24 hours post-dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.