IPI-145 ADME and Absolute Bioavailability Study

NCT ID: NCT01836861

Last Updated: 2021-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-05-31

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

IPI-145 and [14C] IPI-145

Group Type: EXPERIMENTAL

IPI-145

Intervention Type: DRUG

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

Interventions

IPI-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

Intervention Type: DRUG

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

SecuraBio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hagop Youssoufian, MD

Role: STUDY_CHAIR

Verastem, Inc.

Locations

Pharmaceuticals Research Association (PRA)

Zuidlaren, , Netherlands

Countries

Netherlands

Other Identifiers

2012-005425-75

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

IPI-145-05

Identifier Type: -

Identifier Source: org_study_id