IPI-145 ADME and Absolute Bioavailability Study

SecuraBio6 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

IPI-145DRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Pharmaceuticals Research Association (PRA)

Zuidlaren, Netherlands

Outcomes

Primary Outcomes

PK parameters (AUC) of IPI-145 in plasma

Time frame: over 48 hours

PK parameters (AUC) and radioactivity excreted in urine and feces

Time frame: over 144 hours

PK parameters (Cmax) of IPI-145 in plasma

Time frame: over 48 hours

PK parameters (t1/2) of IPI-145 in plasma

Time frame: over 48 hours

PK parameters (Cmax) and radioactivity excreted in urine and feces

Time frame: over 144 hours

PK parameters (t1/2) and radioactivity excreted in urine and feces

Time frame: over 144 hours

Secondary Outcomes

Number of participants with adverse events following a single dose administration of IPI-145

Time frame: over 4 weeks

Data from ClinicalTrials.gov

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