IPI-145 ADME and Absolute Bioavailability Study

Sponsor

SecuraBio (Industry)

Overall Status

Completed

CT.gov ID

NCT01836861

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: IPI-145	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

6 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Study Start Date :

Mar 1, 2013

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Number of participants with adverse events following a single dose administration of IPI-145 [over 4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts 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)