IPI-145 ADME and Absolute Bioavailability Study

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01836861

Enrollment

Registered

2013-04-22

Start date

2013-03-31

Completion date

2013-05-31

Last updated

2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Phase I, healthy male volunteers, ADME, Bioavailability, PI3K inhibitor, Absorption, Distribution, Metabolism, Excretion, safety

Brief summary

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

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.

Interventions

DRUGIPI-145

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
Number of participants with adverse events following a single dose administration of IPI-145	over 4 weeks

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026