Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ISI-P5-416 | Other Identifier | Algorithme Pharma Inc. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RP6530 in fast condition | Experimental | A single dose of RP6530 following fast condition |
|
| RP6530 in fed condition | Experimental | A single dose of RP6530 following fed condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RP6530 | Drug | Single oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Were Evaluated for Adverse Events | Number of Participants Who Were Evaluated for Adverse Events as Assessed by CTCAE v4.0 | 7 days |
| Pharmacokinetic Parameters | Peak Plasma Concentration (Cmax) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric Sicard, M.D | Algorithme Pharma Inc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algorithme Pharma Inc | Québec | H3P 3P1 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | RP6530: Fast Condition First, Then Fed Condition | Fast Condition first, then Fed Condition RP6530: Single oral dose |
| FG001 | RP6530: Fed Condition First, Then Fast Condition | Fed Condition first, then Fast Condition RP6530: Single oral dose |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
18 healthy volunteers were enrolled to get at least 12 completed subjects to demonstrate food effect.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | A single dose of RP6530 following fasting and Fed condition RP6530: Single oral dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | subjects who provided evaluable data for both treatments (Fasting and fed conditions) | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour per millilitre (ng*h/mL) | up to 24 hours post-dose. |
|
Day 1 to Day 7
Subjects who entered the study and received at lease one of the treatments under study.
2 HV dropped in 2nd period in "Fast Condition first, then Fed Condition sequence" similarly, two HV dropped in second period in "Fed Condition first sequence", therefore each treatment had 16 HV for AE evaluation; Fasting 16 and fed 16
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RP6530 in Fast Condition | A single dose of RP6530 following fast condition RP6530: Single oral dose |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Sicard | Algorithme Pharma Inc. | (514) 858-6077 | esicard@algopharm.com |
Not provided
| ID | Term |
|---|---|
| D005215 | Fasting |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| C000706530 | tenalisib |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| up to 24 hours post-dose. |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight | Mean | Standard Deviation | Kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
| Secondary | Number of Participants Who Were Evaluated for Adverse Events | Number of Participants Who Were Evaluated for Adverse Events as Assessed by CTCAE v4.0 | Healthy volunteers | Posted | Count of Participants | Participants | 7 days |
|
|
|
| Secondary | Pharmacokinetic Parameters | Peak Plasma Concentration (Cmax) | Subjects who provided evaluable data for both treatments | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per millilitre (ng/mL) | up to 24 hours post-dose. |
|
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 5 |
| 16 |
| EG001 | RP6530 in Fed Condition | A single dose of RP6530 following fed condition RP6530: Single oral dose | 0 | 16 | 0 | 16 | 5 | 16 |
| Fatigue | General disorders | MedDRA (18.1) | Systematic Assessment |
|
| Vessel puncture site bleeding | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| vessel puncture site swelling | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Protein urine present | Investigations | MedDRA (18.1) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
|
Not provided