IPI-145 ADME and Absolute Bioavailability Study

Study Overview
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Brief Summary
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This is an open-label, 2-period, absorption, distribution, metabolism and excretion (ADME) and absolute bioavailability study in 6 healthy adult male subjects.

Detailed Description
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In Period 1, subjects will receive a single oral dose of 25 mg IPI-145, followed by a 15-minute IV infusion of approximately 2.8 μg 14C-IPI-145 containing 14.8 kBq of radioactivity. In Period 2, the same subjects will receive a single dose of 25 mg 14C-IPI-145 as an oral suspension, containing approximately 3.15 MBq of radioactivity. There will be a washout period of at least 14 days between Period 1 and Period 2.

Official Title
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A Phase 1, Open-Label Study of the Absorption, Distribution, Metabolism and Excretion of 14C-Labeled IPI-145 and the Absolute Bioavailability of IPI-145 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: IPI-145


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males, between 18 and 45 years of age, inclusive Body Mass Index (BMI) : 18.0-30.0 kg/m2 In good health, determined by no clinically significant findings from medical history, physical examination (Check-in), 12-lead ECG, and vital signs Provision of signed and dated, written informed consent prior to any study specific procedures Exclusion Criteria: Evidence of clinically significant medical conditions History of gastrointestinal surgery that may affect drug absorption Positive or indeterminate QuantiFERON-TB Gold test at screening Any active infection at the time of screening or admission Participation in another ADME study with a radiation burden >0.1 mSv in the period of 1 year before screening Irregular defecation pattern (less than once per 2 days)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPI-145 and [14C] IPI-145<br> | Drug: IPI-145<br>* Intravenous infusion: approximately 2.8 μg IPI-145 containing 14.8 kBq of radioactivity; Oral suspension: 25 mg IPI-145 containing approximately 3.15 MBq of radioactivity; Oral capsule: 25 mg IPI-145<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters (AUC) of IPI-145 in plasma |  | over 48 hours | 
| PK parameters (AUC) and radioactivity excreted in urine and feces |  | over 144 hours | 
| PK parameters (Cmax) of IPI-145 in plasma |  | over 48 hours | 
| PK parameters (t1/2) of IPI-145 in plasma |  | over 48 hours | 
| PK parameters (Cmax) and radioactivity excreted in urine and feces |  | over 144 hours | 
| PK parameters (t1/2) and radioactivity excreted in urine and feces |  | over 144 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events following a single dose administration of IPI-145 |  | over 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase I, healthy male volunteers, ADME, Bioavailability, PI3K inhibitor, Absorption, Distribution, Metabolism, Excretion, safety