IPI-145 ADME and Absolute Bioavailability Study

March 15, 2021 updated by: SecuraBio

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Zuidlaren, Netherlands
        • Pharmaceuticals Research Association (PRA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IPI-145 and [14C] IPI-145
Drug: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SecuraBio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

April 1, 2013

First Submitted That Met QC Criteria

April 17, 2013

First Posted (Estimate)

April 22, 2013

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IPI-145-05
  • 2012-005425-75 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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